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KDSWRJORELQODFWDWHGHK\GURJHQDVH /'+ DQGSHULSKHUDOEORRGVPHDU $SSURSULDWHOLYHULPDJLQJLIFOLQLFDOO\LQGLFDWHG x $SSURSULDWHEORRGVDPSOLQJIRUSKDUPDFRNLQHWLFDQDO\VLVLIWKLVKDVQRWDOUHDG\EHHQ FROOHFWHG x +HSDWRORJ\FRQVXOW OLYHUELRSV\PD\EHFRQVLGHUHGLQFRQVXOWDWLRQZLWKDQ KHSDWRORJLVW x )ROORZWKHVXEMHFWDQGWKHODERUDWRU\WHVWV $/7$677%/,15 XQWLODOOODERUDWRU\ DEQRUPDOLWLHVUHWXUQWREDVHOLQHRUQRUPDORUFRQVLGHUHGVWDEOHE\WKH LQYHVWLJDWRU7KH³FORVHREVHUYDWLRQSHULRG´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roduct: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 1 of 80 Amendment 2 Protocol Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention Amgen Protocol Number AMG 334 20120309 Amendment Date: 05 June 2017 Rationale: This is Amendment 2 for AMG 334 Study 20120309. Amendment 1 for this protocol was not implemented and therefore, the changes captured in this document reflect changes made in both Amendment 1 and Amendment 2. The primary change to the protocol is to include a Clinical Home Use (CHU) substudy during the open-label phase. The purpose of the CHU substudy is to assess subject’s ability to administer a full dose of AMG 334 in home use, using either 2 pre-filled 70 mg/mL autoinjectors/pens (Als/pens) or 1 pre-filled 140 mg/mL Al/pen. In addition, the following were clarified to ensure alignment with study procedures: • Updated the open-label treatment phase to include AMG 334 dose increase to 140 mg/mL. • Update the number of subjects that have received at least 1 dose of AMG 334 to date. • Update pregnancy, lactation, and contraception requirements in alignment with Core Risk & Discomforts language. • To align Section 6 (Treatment Procedures), Section 7 (Study Procedures), and Section 10 (Statistical Considerations) with changes made in the pivotal 20120296 study. • To align Section 9 (Safety Data Collection, Recording, and Reporting), Section 12.6 (Publication Policy), and End of Study language with new Amgen protocol template language. • Administration, typographical, and formatting changes were made throughout the protocol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roduct: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 3 of 80 Section: Protocol Synopsis, Clinical Home Use Substudy (During the Open-label Treatment Phase [OLTP]) Objectives Add: Clinical Home Use Substudy (During the Open-label Treatment Phase [OLTP]) Objectives: • Primary Objective: To assess users’ ability to administer a full dose (140 mg) of AMG 334 in home-use, using either 2 pre-filled 70 mg/mL autoinjectors/pens (Als/pens) or 1 pre-filled 140 mg/mL AI/pen • Secondary Objective: To assess the safety and tolerability of AMG 334 administered using either 2 pre-filled 70 mg/mL AIs/pens or 1 pre-filled 140 mg/mL AI/pen Section: Protocol Synopsis, Hypothesis Add: In subjects with episodic migraine, AMG 334 reduces the mean monthly migraine days from baseline, compared to placebo. In the clinical home use (CHU) substudy, it is hypothesized that users will be able to administer a full dose of AMG 334 comparably using 2 pre-filled 70 mg/mL AIs/pens or 1 pre-filled 140 mg/mL AI/pen. No formal hypotheses will be tested in the CHU substudy. Section: Protocol Synopsis, Clinical Home Use Substudy (During the OLTP) Endpoints Add: Clinical Home Use Substudy (During the OLTP) Endpoints: Primary Endpoint: Subject-reported outcome of attempted full-dose administration at day 29 and day 57. Secondary Endpoint: Subject incidence of adverse events, serious adverse events, and adverse device effects Section: Protocol Synopsis, Study Design, Paragraph 2 Add: Approximately 50 subjects will be enrolled in the AMG 334 20120309 CHU substudy to assess the subject’s ability to self-administer 140 mg of AMG 334 for in-home use. Subjects will be randomized 1:1 to use either 2 pre-filled 70 mg/mL AIs/pens or 1 pre-filled 140 mg/mL AI/pen. Participation in the substudy is optional, and no additional samples will be collected for the substudy. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 4 of 80 Section: Protocol Synopsis, Amgen Investigational Product Dosage and Administration, Paragraph 1 Replace: Double-blind AMG 334 140 mg, AMG 334 70 mg, AMG 334 28 mg, or placebo will be administered during the 24-week double-blind treatment phase (ie, at day 1 and weeks 4, 8, 12, 16, and 20) and AMG 334 70 mg will be administered during the 52-week open-label treatment phase (ie, at weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72). With: Double-blind AMG 334 140 mg, AMG 334 70 mg, AMG 334 28 mg, or placebo will be administered during the 24-week double-blind treatment phase (ie, at day 1 and weeks 4, 8, 12, 16, and 20). During the OLTP, AMG 334 70 mg or 140 mg QM SC will be administered, depending on the subject’s visit completion status after institutional review board (IRB) approval of Protocol Amendment 2. Section: Protocol Synopsis, Procedures, Paragraph 1 Replace: At the week 24 visit, subjects will be entered into the 52-week open-label treatment phase and will begin to receive open-label AMG 334 70 mg QM SC. A safety follow-up visit occurs 16 weeks after the last dose of investigational product. Subjects will use an electronic diary (eDiary) every day throughout the baseline phase, double-blind treatment phase and for the first 6 months and last month of the open-label treatment phase to report information about their migraine and non-migraine headaches and acute headache medication use. Subjects will have in-clinic study visits monthly after the week 4 visit. For a full list of study procedures, including the timing of each procedure, please refer to Section 7 and the Schedule of Assessments (Table 2). With: At the week 24 visit, subjects will be entered into the 76-week OLTP and will begin to receive open-label AMG 334. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 5 of 80 After IRB approval of Protocol Amendment 2, the 24-week double-blind treatment phase is followed by a 76- week OLTP with the dose determined by the subject’s week 48 status: (1) Subjects who have already completed the week 48 visit will continue to receive open-label AMG 334 70 mg QM SC (OL70) for a total of 76 weeks. (2) Subjects who have not yet completed the double-blind treatment phase and are not yet in the open-label phase will receive AMG 334 140 mg QM SC (OL140) upon entering the open-label phase and continue receiving open-label AMG 334 140 mg QM SC for 76 weeks. (3) Subjects who have not yet completed the week 48 visit but are in the open-label phase receiving AMG 334 70 mg QM SC must increase their dose to AMG 334 140 mg QM SC and continue receiving open-label AMG 334 140 mg QM SC until the week 100 visit (OL70-140 ) for a total open label phase duration of 76 weeks. The dose increase should be done at the first available opportunity, defined as the first visit after IRB approval of Protocol Amendment 2. Refer to Table 3 for assessments to be collected at the visit of the dose increase and 12 weeks after the dose increase. At the time of the dose increase, the End of Open-label 70 mg electronic case report form (eCRF) page will need to be completed as subjects will be transitioning from 70 mg to 140 mg. As a result of Protocol Amendment 2, there will be 3 possible dose sequences in the open-label phase, depending on completion of week 48 visit as noted above: (1) subjects receiving only AMG 334 70 mg QM SC in the open-label phase (OL70), (2) subjects receiving only AMG 334 140 mg QM SC in the open-label phase (OL140), (3) subjects receiving both AMG 334 70 mg (for up to 24 weeks) and 140 mg QM SC (OL70-OL140). Subjects assigned to receive AMG 334 140 mg QM SC during the open-label phase will not have the option to decrease open-label AMG 334 from 140 mg QM to 70 mg QM. A safety follow-up visit occurs 16 weeks after the last dose of investigational product. Subjects will use an electronic diary (eDiary) every day throughout the baseline phase and double-blind treatment phase and for the first 6 months and between the week 72 and week 76 study visits and between the week 96 and week 100/early termination (ET) study visits of the OLTP to report information about their migraine CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 6 of 80 and non-migraine headaches and acute headache medication use. Subjects will have in-clinic study visits monthly after the week 4 visit. For a full list of study procedures, including the timing of each procedure, please refer to Section 7 and the Schedule of Assessments (Table 2-Table 3, and Table 4 for CHU substudy). Section: Protocol Synopsis, Statistical Considerations, Paragraph 1 Replace: The final analysis for the study will occur after all subjects have completed safety follow-up through week 88 or discontinued from the study. With: The final analysis for the study will occur after all subjects have completed safety follow-up through week 112 or discontinued from the study. Section: Protocol Synopsis, Statistical Considerations, Paragraph 3 Replace: For the open-label treatment phase, follow-up time adjusted subject incidence rate of treatment-emergent adverse events will be tabulated overall. With: For the OLTP, exposure-adjusted subject incidence rate of treatment-emergent adverse events will be tabulated overall. Section: Protocol Synopsis, Statistical Considerations, Paragraph 4 Add: The proportion of subjects who administer a full dose of AMG 334 in home-use will be summarized by treatment group at CHU day 29 and day 57. Subject incidence of adverse events, serious adverse events, and adverse device effects will be summarized by system organ class and preferred term for subjects enrolled in the CHU substudies. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 7 of 80 Section: Protocol Synopsis, Study Design and Treatment Schema, Replace: Study Design and Treatment Schema CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 8 of 80 With: Study Design and Treatment Schema for Subjects That Completed Week 48 under Protocol Amendment 2 (OL70 subjects) CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 9 of 80 Section: Protocol Synopsis, Study Design and Treatment Schema Add: Study Design and Treatment Schema for Subjects Still in the Double-blind Treatment Phase Protocol Amendment 2 (OL140 Subjects) IP = investigational product; QM = monthly; SC = subcutaneous CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 10 of 80 Section: Protocol Synopsis, Study Design and Treatment Schema Add: Study Design and Treatment Schema for Subjects in the Open-label Phase AND Not Yet Completed W48 Under Protocol Amendment 2 (OL70-140 Subjects) IP = investigational product; QM = monthly; SC = subcutaneous CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 11 of 80 Section: Study Glossary Add: AI/Pen Autoinjector/pen ANCOVA Analysis of covariance CHU Clinical home use CMH Cochran-Mantel-Haenszel eCRF Electronic case report form IFU Instructions for use MAR Missing at random MI Multiple imputation MNAR Missing not at random Section: Study Glossary Delete: AE Adverse event Section: Study Glossary Replace: End of Trial The time when the last subject is assessed or receives an intervention for evaluation in the study (ie, when the last subject completes the study, which includes the safety follow-up visit 16 weeks after the last dose of investigational product, or is discontinued from the study) Primary Completion The time when the last subject is assessed or receives an intervention for the purposes of final collection of data for the primary analysis (ie, when the last subject completes the week 24 assessment or is discontinued from the study) CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 12 of 80 Women not of Any female who: childbearing potential • Is post-menopausal by history, defined as: o Age ≥ 55 years with cessation of menses for 12 or more months, OR o Age < 55 years but no spontaneous menses for at least 2 years, OR o Age < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved. OR • Underwent bilateral oophorectomy OR • Underwent hysterectomy OR • Underwent bilateral salpingectomy. With: End of Study The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, the last subject last visit), following any additional parts in the study (eg, long-term follow-up), as applicable. Primary Completion The primary completion date is defined as the time when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint(s), for the purpose of conducting the primary analysis, whether the study concluded as planned in the protocol or was terminated early. The primary completion date is the date when the last subject has completed the assessments for week 24 or is discontinued from the study. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 13 of 80 Women not of • Any female who: childbearing potential o Is post-menopausal by history, defined as: o Age ≥ 55 years with cessation of menses for 12 or more months, OR o Age < 55 years but no spontaneous menses for at least 2 years, OR o Age < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), AND with a follicle-stimulating hormone level > 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved. OR • Underwent bilateral oophorectomy OR • Underwent hysterectomy OR • Underwent bilateral salpingectomy. Section: 1.3 Exploratory, Bullet 18 Replace: • To evaluate the long-term safety, tolerability and maintenance of effect of AMG 334 after 76 weeks of treatment With: • To evaluate the long-term safety, tolerability and maintenance of effect of AMG 334 after 100 weeks of treatment Section: 1.4 Clinical Home Use Substudy Add: 1.4 Clinical Home Use Substudy 1.4.1 Primary The primary objective of the clinical home use (CHU) substudy (during the open-label treatment phase [OLTP]) is to assess users’ ability to administer a full dose (140 mg) of AMG 334 in home-use, using either 2 pre-filled 70 mg/mL autoinjectors/pens (Als/pens) or 1 pre-filled 140 mg/mL AI/pen. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 14 of 80 1.4.2 Secondary Secondary objective of the CHU substudy (OLTP): To assess the safety and tolerability of AMG 334 administered using either 2 pre-filled 70 mg/mL Als/pens or 1 pre-filled 140 mg/mL AI/pen. Section: 2.2 Amgen Investigational Product AMG 334 Background, Paragraph 5 Replace: As of November 2014, approximately 100 subjects (healthy subjects and migraineurs) had participated in Phase 1 studies, and 103 subjects with hot flashes associated with menopause participated in a Phase 2a study. Approximately 152 subjects had received single or multiple doses of AMG 334 in the Phase 1 and Phase 2a studies. AMG 334 has demonstrated a favorable safety and tolerability profile similar to placebo in these studies. Refer to the AMG 334 Investigator’s Brochure for details. With: As of January 2017, approximately 3623 subjects (2786.43 subject years) have received at least 1 dose of AMG 334. This includes 613 healthy volunteers and 2917 migraine subjects. AMG 334 has to date, demonstrated a favorable safety and tolerability profile similar to placebo in these studies. Refer to the AMG 334 Investigator’s Brochure for details. Section: 2.3 Rationale, Paragraph 1 Replace: Migraine prophylaxis is an area of a large unmet medical need, with existing therapies having modest efficacy and being poorly tolerated. With: Migraine prophylaxis is an area of a large unmet medical need, with existing therapies having modest efficacy and poor tolerability. Section: 2.3 Rationale, Rationale for AMG 334 Doses, Paragraph 1 Add: In the open-label phase, the dose of AMG 334 is being increased to 140 mg in a subset of subjects to provide continuous 1-year safety data for subjects receiving either AMG 334 70 mg or 140 mg. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 15 of 80 Section: 2.3 Rationale, Rationale for AMG 334 Doses, Paragraph 3 Delete: AMG 334 140 mg currently is being evaluated in the ongoing chronic migraine study (Study 20120295) and efficacy data are being collected. Section: 2.3 Rationale, Rationale for AMG 334 Doses, Paragraph 5 Replace: In the global Phase 2 episodic migraine study (Study 20120178), treatment-emergent adverse events (AEs) were reported by 165 (51.7%) subjects across all AMG 334 arms, and 82 (53.6%) subjects in the placebo arm. With: In the double blind treatment phase of the global Phase 2 episodic migraine study (Study 20120178), treatment-emergent adverse events were reported by 165 (51.7%) subjects across all AMG 334 arms, and 82 (53.6%) subjects in the placebo arm. Section: 2.3 Rationale, Rationale for AMG 334 Doses, Paragraph 5 Replace: The safety and tolerability data generated to date support further evaluation of the 70-mg dose in the Phase 3 studies. The study 20120178 open-label treatment phase is ongoing. With: The safety and tolerability data generated to date supported further evaluation of the 70-mg dose in the Phase 3 studies. The study 20120178 OLTP is ongoing and the protocol has been amended to increase the open-label dose from 70 mg to 140 mg. Section: 2.3 Rationale, Rationale for AMG 334 Doses, Paragraph 6 and 7 Replace: The 140 mg of AMG 334 is included in the ongoing chronic migraine study (Study 20120295). As of 13 November 2014, 165 subjects had been randomized 3:2:2 to placebo, AMG 334 70 mg, or AMG 334 140 mg, respectively. Approximately 47 subjects had been randomized to the 140 mg group. Blinded interim safety review did CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 16 of 80 not reveal any safety signal. Among all subjects who were randomized in study 20120295, four (4) subjects had discontinued investigational product, with two (2) subjects who discontinued investigational product due to adverse event (constipation, gastroesophageal reflux disease). Most commonly reported adverse events (≥ 2% in any group) included fatigue, muscle spasms, and nasopharyngitis. Five serious adverse events (cholecystectomy, non-cardiac chest pain, pancreatitis, parotitis, vomiting) had been reported and all were deemed by the investigator as not related to investigational product. Overall, the safety data generated to date for both 70 mg and 140 mg of AMG 334 support further evaluation in Phase 3. With: AMG 334 140 mg has been evaluated for the prevention of episodic migraine in a global Phase 3 study (20120296) with a 24-week double-blind treatment phase. The study randomized 955 subjects (AMG 334 70 mg [n = 317], AMG 334 140 mg [n = 319], and placebo [n = 319], QM SC) with a history of migraine with or without aura for ≥ 12 months and a monthly migraine frequency of ≥ 4 to < 15 migraine days. For the primary endpoint of change in monthly migraine days from baseline to the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase, the 70 mg and 140 mg doses were significantly different from placebo (-3.23 days and -3.67 days vs. -1.83 days, p < 0.001). Both doses produced statistically significant improvements in the secondary outcome measures of 50% responder rate and monthly migraine-specific medication treatment days. The results of the other secondary endpoints were consistent with those of the primary endpoint. Across the primary and all secondary endpoints, AMG 334 140 mg showed numerically greater efficacy than 70 mg. At the end of the double-blind treatment phase, subjects in each treatment group are re-randomized 1:1 in a blinded fashion to AMG 334 70 mg or AMG 334 140 mg for the 28-week active treatment phase, which is ongoing. During the placebo-controlled double-blind treatment phase of the 20120296 study, treatment-emergent adverse events were reported in 57.3%, 55.5%, and 63.0% of subjects in the AMG 334 70 mg, AMG 334 140 mg, and placebo groups, respectively, and most were Common Terminology Criteria for Adverse Events [CTCAE] grade 1 or 2 (mild to moderate in severity). Study drug discontinuations due to adverse events were reported in 7 subjects (2.2%), CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 17 of 80 6 subjects (1.9%), and 7 subjects (2.2%) in the AMG 334 70 mg, AMG 334 140 mg, and placebo groups, respectively. The most frequent adverse events occurring in ≥ 2% of all AMG 334 treated subjects were nasopharyngitis, upper respiratory tract infection, sinusitis, constipation, arthralgia, fatigue, and nausea. Serious adverse events were reported in 2.5%, 1.9%, and 2.2% of subjects in the AMG 334 70 mg, AMG 334 140 mg, and placebo groups, respectively. No serious adverse event occurred in more than 1 subject, except cholelithiasis which was reported by 2 subjects in the AMG 334 70 mg group (one of whom had clear risk factors). Study 20120296 and Study 20120309 are being monitored by the same independent DMC. In the global 12-week study 20120295, 667 subjects with chronic migraine (≥ 15 headache days per month, with ≥ 8 migraine days) were randomized to AMG 334 70 mg (n = 191), AMG 334 140 mg (n = 190), or placebo (n = 286), QM SC. For the primary endpoint of change in monthly migraine days from baseline to the last 4 weeks of the 12-week double-blind treatment phase, the 70 mg and 140 mg doses were significantly different from placebo (-6.64 days and -6.63 days vs. -4.18 days, p < 0.001). Treatment-emergent adverse events were reported in 39.0%, 43.7%, and 46.8% of subjects in the placebo, AMG 334 70 mg, and AMG 334 140 mg groups, respectively. No apparent dose-response pattern was observed across the most common treatment-emergent adverse events. The most commonly reported adverse events occurring in ≥ 2% of all AMG 334 treated subjects were injection site pain, upper respiratory tract infection, nausea, nasopharyngitis, constipation, muscle spasms, and migraine. Serious adverse events were reported in 2.5%, 3.2%, and 1.1% of subjects in the placebo, AMG 334 70 mg, and AMG 334 140 mg groups, respectively. No individual serious adverse event was reported in more than 1 subject in the placebo, AMG 334 70 mg, or AMG 334 140 mg groups. Subjects from 20120295 were eligible to enroll in an ongoing 52-week open-label extension study (20130255), in which the original dose was 70 mg QM SC, but subsequently the dose was increased to 140 mg QM SC. Of the 609 subjects enrolled, 259 subjects received at least one dose of AMG 334 140 mg. Based on the interim analysis data cut-off of 01 September 2016 with a mean (SD) duration of exposure to AMG 334 140 mg of 176.4 (70.9) days, the reported adverse events were consistent with the known safety profile of AMG 334. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 18 of 80 The global Phase 2 study (20120178) in episodic migraine has an ongoing open-label phase of up to 256 weeks. The original dose was 70 mg but a protocol amendment dated 07 April 2016 increased the dose to 140 mg for all subjects. Thus 140 mg has been investigated in the double-blind portions of studies 20120296 and 20120295, as well in open-label or active treatment extension phases (studies 20120296, 20130255, 20120178), and no new safety signal has been detected. Section: 2.3 Rationale, Rationale for AMG 334 Doses, Figure 2 and Table 1 Delete: Figure 2. Predicted AMG 334 Exposure and Capsaicin-induced Dermal Blood Flow (DBF) Inhibition for the Phase 2 Doses Up to 52 Weeks of Dosing in the Japan Phase 2 Study Figure legends: 50th (solid lines), 5th and 95th (lower and upper dashed lines) percentiles of predictions. Estimated mean maximum inhibition in DBF response from Phase 1 study is approximately 93%. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 19 of 80 Table 1. Predicted Safety Margins as Ratios of Exposure After SC Dosing of 70 mg Q4W Compared to Exposure Following the Highest Tested Safe Dose in Studies 20101267 and 20101268 Observed Multiple Dose Highest Observed Single Exposure at 140 mg SC Predicted Exposure After Dose Exposure: Q4W: Predicted Third Dose of Predicted Exposure at Exposure at 70 mg SC 70 mg Q4W SC 70 mg SC Q4W* Q4W# Mean AUC0- 28D Mean Cmax Weight $ (kg) (µg•day/mL) (µg/mL) AUC Cmax AUC Cmax 72 201 9.4 2.0 5.1 2.4 2.5 53 284 13 1.4 3.7 1.7 1.8 SC = subcutaneous; Q4W = once every 4 weeks; AUC = area under the curve; Cmax = maximum concentration. $: 72 -kg reference weight for non-Japanese subjects and 53 -kg as typical body weight for a Japanese female subject *: Ratios of observed 140 mg IV single dose PK to predicted 70 mg SC Q4W PK after third dose; observed mean (%CV) AUC0-28D and Cmax in Study 20101267 at 140 mg IV SD are 403 µg⋅day/mL (12.8) and 47.8 µg/mL (8.55), N=6, respectively #: Ratios of observed 140 mg SC Q4W PK to predicted 70 mg SC Q4W PK after third dose; observed preliminary mean (%CV) AUC0-28D and Cmax for 140 mg SC Q4W after third dose in Study 20101268 are 475 µg⋅day/mL(33.8) and 23.7 µg/mL (33.3), respectively. Section: 2.4 Clinical Hypothesis, Paragraph 1 Add: In subjects with episodic migraine, AMG 334 reduces the mean monthly migraine days from baseline, compared to placebo. In the CHU substudy, it is hypothesized that users will be able to administer a full dose of AMG 334 comparably using 2 pre-filled 70 mg/mL AIs/pens or 1 pre-filled 140 mg/mL AI/pen. No formal hypotheses will be tested in the CHU substudy. Section: 3.1 Study Design, Paragraph 1 Replace: The study is composed of an initial screening phase (up to 3 weeks), a 4-week baseline phase, a 24-week double blind treatment phase, a 52-week open-label treatment phase, and an 12-week safety follow-up phase (16 weeks after the last dose of investigational product). CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 20 of 80 With: The study is composed of an initial screening phase (up to 3 weeks), a 4-week baseline phase, a 24-week double-blind treatment phase, a 76-week OLTP, and a 12-week safety follow-up phase (16 weeks after the last dose of investigational product). Section: 3.2 Clinical Home Use Study Design (Optional) (new section) Add: 3.2 Clinical Home Use Study Design (Optional) Approximately 50 subjects will be enrolled in this AMG 334 20120309 CHU substudy to assess subjects’ ability to self-administer 140 mg of AMG 334 for in-home use. Subjects will be randomized 1:1 to use either 2 pre-filled 70 mg/mL AIs/pens (for a total dose of 140 mg) or 1 pre-filled 140 mg/mL AI/pen. It is hypothesized that users will be able to self-administer a full dose of AMG 334 comparably using either dosage. No formal hypotheses will be tested. Safety and tolerability of AMG 334 self-administered using two 70 mg/mL AIs/pens or one 140 mg/mL AI/pen will also be assessed. Participation in the substudy is optional and no additional samples are collected for the substudy. Subjects who elect to participate in this CHU substudy will be required to provide separate informed consent and must meet the eligibility criteria. CHU substudy screening (day -28) should occur during or after a subject has received at least 1 dose of open-label AMG 334 140 mg. Subjects should also review the AI/pen instructions for use (IFU) at day -28 of the CHU substudy to determine if they wish to enroll in the substudy at day 1. Subjects must have received at least 1 dose of AMG 334 140 mg by day 1 of the CHU substudy. Day 1 of the CHU substudy should correspond with any 20120309 study visit up through week 88. At day 1, subjects who meet all eligibility criteria will be randomized via IVR System to self-administer AMG 334 using either two 70 mg/mL AIs/pens or one 140 mg/mL AI/pen (approximately 25 subjects in each arm). At CHU substudy day 1, areas that may be injected (upper arm, abdomen, or upper thigh) should be examined for any skin abnormalities; adverse events, serious adverse events, and adverse device effects will be collected during the CHU substudy, and will be assessed on CHU screening, day 1, day 28 (at site), and day 56 (at site) and on CHU substudy days 29 and 57 (assessed by telephone visit). CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 21 of 80 Adverse event, serious adverse event, adverse device effect, concomitant medication therapies, vital signs measurement, ECGs, urinalysis, and blood draw for serum chemistry and hematology analytes, and anti-AMG 334 antibody assay will be performed as described in the main study. On the CHU substudy day 1 visit, the site should review the IFU with the subject before administration of IP. On day 1 of the substudy, subjects will self-administer IP (two 70 mg/mL AIs/pens or one 140 mg/mL AI/pen) under clinical site supervision. Subjects will be provided a box containing either two 70 mg/mL AI/pens or one dose of 140 mg AI/pen at the CHU substudy day 28 and day 56 visits and will self-administer IP individually without supervision at home on substudy days 29 and 57 of the CHU substudy. On CHU day 29 and day 57, site staff will call the subject at a previously scheduled time and will ask the subject which injection site was used, if the subject administered a full, partial, or no dose of AMG 334 (after explaining that a full dose means that the entire volume of the AI/pen was injected) and will document the subject’s response in the eCRF. If the subject was not able to administer a full dose of AMG 334, the site staff will inquire further to determine if the subject experienced a device failure or use error that prevented the full-dose administration. Safety will be monitored as adverse events, serious adverse events, and adverse device effects. Day 85 (clinic visit) is the end of the CHU substudy and sites will inquire about adverse events, serious adverse events, and adverse device effects. At day 85 of the CHU substudy, site staff will administer AMG 334 140 mg SC and will continue the scheduled procedures and assessments as per the 20120309 protocol. If a subject terminates the CHU substudy early, the subject may receive administration of AMG 334 140 mg SC at the site as per the 20120309 protocol and will continue 20120309 scheduled procedures and assessments as per the 20120309 protocol. Section: 3.4 Number of Subjects, Paragraph 4 Add: Approximately 50 subjects may participate in the CHU substudy. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 22 of 80 Section: 3.6.1 Study Duration for Subjects, Paragraph 1 Replace: The planned length of participation in the study for an individual subject is up to 95 weeks, which includes the following: With: The planned length of participation in the study for an individual subject is up to 119 weeks, which includes the following: Section: 3.6.1 Study Duration for Subjects, Bullet 4 Replace: • 52-week open-label treatment phase With: • 76-week OLTP Section: 3.6.2 End of Study Replace: Primary Completion: The time when the last subject is assessed or receives an intervention for the purposes of final collection of data for the primary analysis (such as when the last subject completes the week 24 assessment or is discontinued from the study). End of Trial: The time when the last subject is assessed or receives an intervention for evaluation in the study (ie, when the last subject completes the study, which includes the safety follow-up visit 16 weeks after the last dose of investigational product, or is discontinued from the study). With: Primary Completion: The primary completion date is defined as the time when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint(s), for the purpose of conducting the primary analysis, whether the study concluded as planned in the protocol or was terminated early. The primary completion date is the date when the last subject has completed the assessments for week 24 or is discontinued from the study). CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 23 of 80 If the study concludes prior to the primary completion date originally planned in the protocol (ie, early termination of the study), then the primary completion will be the date when the last subject is assessed or receives an intervention for evaluation in the study (ie, last subject last visit). End of Study: The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), following any additional parts in the study (eg, long-term follow-up), as applicable. Section: 4.1 Inclusion Criteria, Criterion 109 Add: CHU Substudy: • Subjects must have provided informed consent for the substudy. Subjects enrolling in the CHU substudy must have received open-label 140 mg AMG 334 for at least 1 dose. Section: 4.2 Exclusion Criteria, Criterion 221, Bullet 6 Sub-bullet 3 Replace: . Age < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved. With: . Age < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), AND with a follicle-stimulating hormone level > 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved. Section: 4.2 Exclusion Criteria, Criterion 227 Add: CHU Substudy 227 Unreliability as a study participant based on the investigator’s (or designee’s) knowledge of the subject (eg, unwillingness to adhere to the protocol, unwilling to self-inject using an AI/pen after review of the IFU). Subjects receiving AMG 334 70 mg in the open-label phase are not eligible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¶VYLVLWFRPSOHWLRQVWDWXVDIWHU,5% DSSURYDORI3URWRFRO$PHQGPHQW 6HFWLRQ 'RVDJH$GPLQLVWUDWLRQDQG6FKHGXOH3DUDJUDSK 5HSODFH ,QYHVWLJDWLRQDOSURGXFWGRVHVDUHIL[HGLQHDFKSKDVHRIWKHVWXG\DQGZLOOQRWEH DGMXVWHGIRULQGLYLGXDOVXEMHFWV'XULQJWKHGRXEOHEOLQGWUHDWPHQWSKDVH6& LQMHFWLRQVDUHWREHJLYHQIRUHDFKLQYHVWLJDWLRQDOSURGXFWDGPLQLVWUDWLRQ LHDWGD\DQG ZHHNVDQG WRPDLQWDLQWKHGRVHOHYHOEOLQGLQJ7KH6&LQMHFWLRQV &21),'(17,$/ Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 26 of 80 should be separated by no more than approximately 1 minute. During the open-label treatment phase, only 1 SC injection is to be given for each investigational product administration (ie, at weeks 24, 28, etc.). The anatomical sites for administration of investigational product are the upper arm, upper thigh, or abdomen. Please see the IPIM for investigational product details. With: During the double-blind treatment phase, 3 SC injections are to be given for each investigational product administration (ie, at day 1 and weeks 4, 8, 12, 16, and 20) to maintain the dose-level blinding. The 3 SC injections should be separated by no more than approximately 1 minute. During the OLTP, 1 SC injection is to be given for AMG 334 70 mg and 2 SC injections for AMG 334 140 mg. If and when 140 mg/mL pre-filled syringes become available during the open-label phase, the 140 mg dose may be administered by a single 140 mg/mL SC injection. After IRB approval of Protocol Amendment 2, after the 24-week double-blind treatment phase, there is a 76-week OLTP with the dose determined by the subject’s week 48 status: (1) Subjects who have already completed the week 48 visit will continue to receive open-label AMG 334 70 mg QM SC (OL70) for a total of 76 weeks. (2) Subjects who have not yet completed the double-blind treatment phase and are not yet in the open-label phase will receive AMG 334 140 mg QM SC (OL140) upon entering the open-label phase and continue receiving open-label 140 mg QM SC for 76 weeks. (3) Subjects who have not yet completed the week 48 visit but are in the open-label phase receiving AMG 334 70 mg QM SC must increase their dose to AMG 334 140 mg QM SC and continue receiving open-label AMG 334 140 mg QM SC until the week 100 visit (OL70-140 ) for a total open-label phase duration of 76 weeks. The dose increase to 140 mg should be done at the first available opportunity, defined as the first visit after IRB approval of Protocol Amendment 2. At the time of the dose increase, the End of Open-label 70 mg eCRF page will need to be completed as subjects will be transitioning from 70 mg to 140 mg. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 27 of 80 As a result of Protocol Amendment 2, there will be 3 possible dose sequences in the open-label phase, depending on completion of week 48 visit as noted above: (1) subjects receiving only AMG 334 70 mg QM SC in the open-label phase (OL70), (2) subjects receiving only AMG 334 140 mg QM SC in the open-label phase (OL140), and (3) subjects receiving both AMG 334 70 mg (for up to 24 weeks) and 140 mg QM SC (OL70-140). Subjects assigned to receive AMG 334 140 mg QM SC during the open-label phase will not have the option to decrease open-label AMG 334 from 140 mg QM to 70 mg QM. The anatomical sites for administration of investigational product are the upper arm, upper thigh, or abdomen. Please see the IPIM for investigational product details. Section: 6.2.1.1 Dosage, Administration, and Schedule, Paragraph 7 Add: During the CHU substudy, the subject will self-administer IP (1 or 2 injections using AI/pen) under site supervision on day 1. On day 28 and day 56 during the CHU substudy, the site will provide IP to the subject to self-administer (1 or 2 injections using AI/pen) on the next day. The anatomical sites for self-administration are the upper thigh or abdomen. The upper arm should only be used if administered by a care-giver. During the CHU substudy the injection site location should be the same for all injections but do not use the same spot on the injection site you used for a previous injection. For further details regarding self-administration procedures, the IFU should be consulted. Section: 6.2.1.1 Dosage, Administration, and Schedule, Paragraph 11 Add: If a subject is enrolled in the CHU substudy, the box number provided to the subject and information obtained at telephone visits should be recorded by the site on each subject’s CRF, as described in Section 7.2.25. Section: 6.2.1.2 Dosage Adjustments, Delays, Rules for Withholding or Restarting, Permanent Discontinuation, Paragraph 5 Replace: Subjects who permanently discontinue investigational product during the open-label treatment phase are to complete the study procedures for the week 76/early termination CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 28 of 80 (ET) visit and the safety follow-up visit 16 weeks after the last dose of investigational product. With: Subjects who permanently discontinue investigational product during the OLTP are to complete the study procedures for the week 100/early termination (ET) visit and the safety follow-up visit 16 weeks after the last dose of investigational product. Section: 6.3 Hepatoxicity Stopping and Rechallenge Rules Replace: 6.3 Hepatoxicity Stopping and Rechallenge Rules Subjects with abnormal hepatic laboratory values (ie, alkaline phosphatase [ALP], aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin [TBL]) and/or international normalized ratio [INR] and/or signs/symptoms of hepatitis (as described below) may meet the criteria for withholding or permanent discontinuation of Amgen investigational product (as specified in the Guidance for Industry Drug-Induced Liver Injury: Premarketing Clinical Evaluation, July 2009). 6.3.1 Criteria for Permanent Discontinuation of Amgen Investigational Product Due to Potential Hepatotoxicity Amgen investigational product will be discontinued permanently and the subject should be followed according to the recommendations in Appendix A (Additional Safety Assessment Information) for possible drug-induced liver injury (DILI), if ALL of the criteria below are met: • TBL > 2x upper limit of normal (ULN) or INR > 1.5 • AND increased AST or ALT from the relevant baseline value as specified below: Baseline AST or ALT value AST or ALT elevation < ULN > 3x ULN • AND no other cause for the combination of the above laboratory abnormalities is immediately apparent; important alternative causes for elevated AST/ALT and/or TBL values include, but are not limited to: − Hepatobiliary tract disease − Viral hepatitis (eg, Hepatitis A/B/C/D/E, Epstein-Barr Virus, cytomegalovirus, Herpes Simplex Virus, Varicella, toxoplasmosis, and Parvovirus) − Right sided heart failure, hypotension, or any cause of hypoxia to the liver causing ischemia CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 29 of 80 − Exposure to hepatotoxic agents/drugs or hepatotoxins, including herbal and dietary supplements, plants, and mushrooms − Heritable disorders causing impaired glucuronidation (eg, Gilbert’s Syndrome, Crigler-Najjar syndrome) and drugs that inhibit bilirubin glucuronidation (eg, indinavir, atazanavir) − Alpha-one antitrypsin deficiency − Alcoholic hepatitis − Autoimmune hepatitis − Wilson’s disease and hemochromatosis − Nonalcoholic Fatty Liver Disease including Nonalcoholic Steatohepatitis (NASH) − Non-hepatic causes (eg, rhabdomylosis, hemolysis) 6.3.2 Criteria for Conditional Withholding of Amgen Investigational Product Due to Potential Hepatotoxicity For subjects who do not meet the criteria for permanent discontinuation of Amgen investigational product outlined above and have no underlying liver disease, and eligibility criteria requiring normal transaminases and TBL at baseline or subjects with underlying liver disease and baseline abnormal transaminases, the following rules are recommended for withholding of Amgen investigational product: • Elevation of either AST or ALT according to the following schedule: Baseline AST or ALT value AST or ALT elevation Any > 8x ULN at any time Any > 5x ULN but < 8x ULN for ≥ 2 weeks Any > 5x ULN but < 8x ULN and unable to adhere to enhanced monitoring schedule Any > 3x ULN with clinical signs or symptoms that are consistent with hepatitis (such as right upper quadrant pain/tenderness, fever, nausea, vomiting, jaundice) • OR: TBL > 3x ULN at any time • OR: ALP > 8x ULN at any time Amgen investigational product should be withheld pending investigation into alternative causes of DILI. If investigational product is withheld, the subject is to be followed according to recommendations in Appendix A for possible DILI. Rechallenge may be considered if an alternative cause for impaired liver tests (ALT, AST, ALP) and/or elevated TBL, is discovered and the laboratory abnormalities resolve to normal or baseline (Section 6.3.3). CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 30 of 80 6.3.3 Criteria for Rechallenge of Amgen Investigational Product After Potential Hepatotoxicity The decision to rechallenge the subject should be discussed and agreed upon unanimously by the subject, investigator, and Amgen. If signs or symptoms recur with rechallenge, then Amgen investigational product should be permanently discontinued. Subjects who clearly meet the criteria for permanent discontinuation (as described in Section 6.3.1) should never be rechallenged. With: 6.3 Hepatotoxicity Stopping Rules Refer to Appendix A for details regarding drug-induced liver injury (DILI) guidelines, as specified in the Guidance for Industry Drug-Induced Liver Injury: Premarketing Clinical Evaluation, July 2009. Section: 6.4 Concomitant Therapy, Paragraph 4 Add: During the initial screening phase, the subject and investigator are to agree on the acute headache medications shown below (Table 1) and the appropriate dose(s) that the subject may take on an as-needed basis (PRN) throughout the study. Section: 6.4 Concomitant Therapy, Table Header Add: Table 1. List of Acute Headache Medications Section: 6.5 Medical Devices, Paragraph 3 Add: In the CHU substudy, the AMG 334 SureClick AI/pen is a single-use, disposable, handheld mechanical injection device that administers a fixed-dose of AMG 334 into SC tissue. The AMG 334 AI/pen uses the same components as the commercially available Repatha SureClick autoinjector. Subjects participating in the CHU substudy will return the AIs/pens to the clinic for reconciliation and disposal by the site staff using a plastic box provided by Amgen to the clinical sites. Medical devices that are not considered test articles may be used in the conduct of the study as part of standard of care (except for CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 31 of 80 AI/pen). The investigator will be responsible for obtaining supplies of these devices. Detailed information regarding the medical devices will be provided separately in the IPIM. Section: 6.6 Product Complaints, Paragraph 1 Replace: A product complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of any product(s) or device(s) after it is released to the clinic by Amgen or by distributors, and partners with whom Amgen manufactures the material. This includes any products or devices provisioned and/or repackaged/modified by Amgen. With: A product complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of any product(s) or device(s) after it is released for distribution to market or clinic by either Amgen or by distributors, and partners with whom Amgen manufactures the material. This includes any products, devices, combination product(s) provisioned and/or repackaged/modified by Amgen. Drug(s) or device(s) includes investigational product. Section: 6.7 Excluded Therapies Prior to the Start of the Baseline Phase and Throughout the Study, Number 5 Replace: 5. Investigational medications, devices, and procedures are excluded throughout the study. Subjects also must not have used investigational medications, devices or procedures for at least 90 days prior to screening (refer to Exclusion Criterion 222). With: 5 Investigational medications and devices are excluded throughout the study. Subjects also must not have used investigational medications, devices or procedures for at least 90 days prior to screening (refer to Exclusion Criterion 222). CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 32 of 80 Section: 7 Study Procedures, Paragraph 1 Add: Refer to the Schedule of Assessments (Table 2-Table 4) for an outline of the procedures required at each study visit. Section: 7 Study Procedures, Paragraph 3, Bullet 3 Replace: • Each study visit during the 52-week open-label treatment phase has a window of ± 4 consecutive calendar days. With: • Each study visit during the 76-week OLTP has a window of ± 4 consecutive calendar days. Section: 7 Study Procedures, Paragraph 4 Add: Refer to the Schedule of Assessments (Table 4) for an outline of the procedures required at each study visit in the CHU substudy. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 33 of 80 Section: 7.1 Schedule of Assessments, Table 2 Add: Screening Phase (up to 7 wks) Double-blind Treatment Phase (24 wks) 1 Baseline Phase Initial (4 wks) 1 Screening D 1 D 1 (up to Wk (pre- (post- Wk 24 / Procedures 3 wks) 2 -4 rand.) rand.) Wk 4 Wk 8 Wk 12 Wk 16 Wk 20 ET 3 Medical and Medication History X X Employment Status 15 X X X Adverse Event/Serious Adverse Event X (SAEs only) X X X X X X X Collection/Recording/Reporting 16 Section: 7.1 Schedule of Assessments, Table 2, Footnotes Replace: Footnotes defined on last page of the second table With: Footnotes defined on last page of Table 4. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 34 of 80 Section: 7.1 Schedule of Assessments, Table 3 Replace: Safety Open-label Treatment Phase (OLTP) (52 wks) 1 F/U 1 16 Wks Wk Wk After Last 24 Wk Wk Wk Wk Wk Wk Wk Wk Wk 76 Dose of Procedures (cont) 28 Wk 32 36 40 44 48 52 56 60 Wk 64 68 Wk 72 /ET IP Study Visit X X X X X X X X X X X X X X X Calls to IVR/IWR System 2 X X X X X X X X X X X X X X X Entry into the OLTP 6 X PE X Body Weight Measurement 7 X X X X X X Vital Signs 8 X X X X X X X X X X X X X X UDS Testing as needed throughout study based on investigator’s clinical suspicion Pregnancy Testing- Serum 9 X Pregnancy Testing- Urine 9 X X X X X X X X X X X X X Chemistry, Hematology X X X X X ECG X X X X X PK Sampling 10 X X X X X Anti-AMG 334 Antibodies; X X X X X Serum COAs 14 X (Daily) X (Daily) Subject Brings eDiary to Site X X X X X X X X for Use during Study Visit Migraine Symptom X (Daily) X (Daily) Interference Items 14 Migraine Physical Function X (Daily) X (Daily) Impact Stand-alone Item 14 HIT-6 14 X X X X X X X X X X X X X C-SSRS X X X X X X X X X X X X X X Concomitant Medications X X X X X X X X X X X X X X Recording IP Administration 15 X X X X X X X X X X X X X Adverse Event Recording 16 X X X X X X X X X X X X X X X Product Complaints X X X X X X X X X X X X X Recording CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 35 of 80 With: Safety Open-label Treatment Phase (OLTP) (76 wks) 1 F/U 1 Dose 12 wk increase to post 16 Wks Wk 24 Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk 100 140 mg increaseAfter Last Procedures (cont) 28 32 36 40 Wk 44 Wk 48 Wk 52 Wk 56 Wk 60 Wk 64 Wk 68 Wk 72 76 80 84 88 92 96 /ET3 visit18 18 Dose of IP Study Visit X X X X X X X X X X X X X X X X X X X X X X X Calls to IVR/IWR X X X X X X X X X X X X X X X X X X X X X X X System 2 Entry into the OLTP 6 X PE X X X X X Body Weight X X X X X X X X Measurement 7 Vital Signs 8 X X X X X X X X X X X X X X X X X X X X X X UDS Testing as needed throughout study based on investigator’s clinical suspicion Pregnancy Testing- X Serum 9 Pregnancy Testing- X X X X X X X X X X X X X X X X X X X X X Urine 9 Chemistry, X X X X X X X X Hematology ECG X X X X X X X X X PK Sampling 10 X X X X X X X X Anti-AMG 334 X X X X X X X X Antibodies; Serum Page 1 of 2 Footnotes defined on last page of Table 4. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 36 of 80 Safety Open-label Treatment Phase (OLTP) (76 wks) 1 F/U 1 Dose 12 wk increase to post 16 Wks Wk 24 Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk 100 140 mg increaseAfter Last Procedures (cont) 28 32 36 40 Wk 44 Wk 48 Wk 52 Wk 56 Wk 60 Wk 64 Wk 68 Wk 72 76 80 84 88 92 96 /ET3 visit18 18 Dose of IP X COAs 14 X (Daily) X (Daily) (Daily) Subject Brings eDiary to Site for Use during X X X X X X X X X Study Visit Migraine Symptom X X (Daily) X (Daily) Interference Items 14 (Daily) Migraine Physical X Function Impact X (Daily) X (Daily) (Daily) Stand-alone Item 14 HIT-6 14 X X X X X X X X X X X X X X X X X X X X X C-SSRS X X X X X X X X X X X X X X X X X X X X X X Employment Status X X X 17 Concomitant X X X X X X X X X X X X X X X X X X X X X X Medications Recording IP Administration 15 X X X X X X X X X X X X X X X X X X X X X Adverse Event/Adverse Device Effects/Serious X X X X X X X X X X X X X X X X X X X X X X X Adverse Event Collection /Recording/Reporting 16 Product Complaints X X X X X X X X X X X X X X X X X X X X X Recording Page 2 of 2 Footnotes defined on last page of Table 4. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 37 of 80 Section: 7.1 Schedule of Assessments, Table 4 Add: Table 4. Clinical Home Use Substudy Assessments Day 29 Day 57 Day 85 visit21/ Screening19 Day 120 Day 28 visit Telephone Day 56 visit Telephone ET22 visit visit Informed Consent X Randomization to AMG 334 70 mg/ml AI/pen x2 or AMG 334 140 mg/ml X AI/pen IP self-administration arm AI/pen Instruction23 X X Examination of areas for injection X Self-administration IP on-site X Self-administration IP at non-clinic X X setting Study coordinator IP dispense X X Study coordinator IP reconcile X X X Inquiry re: administration of IP X X Review for Adverse Device Effects X X X X X X X Review for adverse events/serious X X X X X X X adverse events Product Complaints Recording (if X X X X X X applicable) CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 38 of 80 Section: 7.1 Schedule of Assessments, Table 4 Footnotes (moved from Table 3 to Table 4) Replace: AE = adverse event; BDI-II = Beck Depression Inventory-II; CGRP = Calcitonin gene-related peptide; COAs = Clinical Outcomes Assessments; cont = continued; C SSRS = Columbia-Suicide Severity Rating Scale; D = day; DBTP = Double-blind Treatment Phase; ECG = electrocardiogram; eDiary = electronic diary; EOS = end of study; EOT = end of treatment; ET = early termination; F/U = follow-up; HIT-6 = Headache Impact Test; IP = investigational product; IVR = interactive voice response; IWR = interactive web response; M = month (end of month x); OLTP = open-label treatment phase; PE = physical exam; per. = period; PK = pharmacokinetics; QM = monthly; rand. = randomized / randomization; SAE = serious adverse event; SC = subcutaneous; UDS = urine drug screen; Wk = week (end of week x); Wkly = weekly 1 Each study visit during the double-blind treatment phase and safety follow-up has a window of ± 3 consecutive calendar days. The day 1 visit (randomization day) has a window of 0, +7 consecutive calendar days; the day 1 visit must occur 28 to 35 days after the week -4 visit date. Each study visit during the open-label treatment phase has a window of ± 4 consecutive calendar days. All study visit target dates are to be calculated from the day 1 visit date. All study procedures for a given study visit are to be completed on the same day. 2 Sites to access the Interactive Voice Response (IVR) / Interactive Web Response (IWR) System for the following: to enter the subject into the initial screening phase, to randomize an eligible subject, to obtain the investigational product assignment, to enter the subject into the open-label treatment phase, to register the end of investigational product, and to register study early termination or completion. Subject data will be collected in the IVR/IWR System including, but not limited to reason for screen fail (if applicable). Sites to access the IVR/IWR System to obtain the investigational product assignment at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72. The IVR/IWR System will automatically assign investigational product when a subject is randomized at day 1 and when a subject is entered into the open-label treatment phase at week 24. Investigational product is dosed QM, SC. 3 A subject who discontinues the study during the double-blind treatment phase will complete the week 24/early termination (ET) visit. A subject who discontinues open-label investigational product or the study during the open-label treatment phase will complete the week 76/early termination (ET) visit. Subjects also will complete the safety follow-up visit 16 weeks after the last dose of investigational product. 4 Entry into the baseline phase must occur only after completion of initial screening phase procedures 6 Enrollment (ie, randomization) into the double-blind treatment phase using the IVR/IWR System must occur only after completion of all baseline phase procedures and prior to the first dose of double-blind investigational product (randomization and administration of the first dose of investigational product should occur on day 1) 6 Entry into the open-label treatment phase using the IVR/IWR System must occur only after completion of all double-blind treatment phase procedures and prior to the first dose of open-label AMG 334 70 mg QM SC 7 Height and weight, measured without shoes. Height to be collected at the initial screening phase visit only. 8 Systolic/diastolic blood pressure, heart rate and body temperature. Blood pressure to be obtained after the subject has been in a semi-recumbent position (partial semi- Fowler’s position) or supine position in a rested and calm state for at least 5 minutes. At least 2 measurements (separated by at least 5 min) should be made and the average recorded. The position selected for a subject should be used for all blood pressure measurements throughout the study. 9 Pregnancy testing for women of childbearing potential (WOCBP) 10 Samples for PK assessment will be serum 11 PK samples collected at a study visit during which investigational product will be administered should be collected before dosing with investigational product (trough) 12 Only subjects participating in the optional PK substudy (must have provided informed consent for the PK substudy) will have blood samples collected on day 8 and day 64. The PK substudy sampling window is ± 3 consecutive calendar days. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 39 of 80 13 For subjects who provided informed consent for the pharmacogenetic studies, DNA will be obtained from the cell pellet collected in the plasma tube used for the biomarker development sample. Therefore, additional sampling is not required. 14 Clinical Outcomes Assessments (COAs) and Patient-reported Outcomes (PROs) to be collected by subjects using eDiaries. The HIT-6 is to be completed during applicable study visits before invasive procedures (eg, blood draws) and investigational product administration. 15 Site study staff to administer investigational product to subjects on day 1 (only after randomization and completion of all day 1 procedures) and at weeks 4, 8, 12, 16, 20, 24 (only after entering the open-label treatment phase and completion of all week 24 procedures), 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72. Investigational product administration should occur after any trough PK sampling. Sites are to record the time of investigational product administration. Following the first 3 doses of investigational product in the double-blind treatment phase (ie, day 1, week 4, week 8), subjects are to remain in the clinic for approximately 1 hour for observation. 16 SAEs are to be collected after signing of the informed consent through end of study (16 weeks after the last dose of investigational product). Non-serious AEs are to be collected after the first dose of investigational product through end of study (16 weeks after the last dose of investigational product). With: ADE = adverse device effect; AE = adverse event; AI = autoinjector; BDI-II = Beck Depression Inventory-II; CGRP = Calcitonin gene-related peptide; CHU = clinical home use; COAs = Clinical Outcomes Assessments; cont = continued; C-SSRS = Columbia-Suicide Severity Rating Scale; D = day; DBTP = Double-blind Treatment Phase; ECG = electrocardiogram; eDiary = electronic diary; EOS = end of study; EOT = end of treatment; ET = early termination; F/U = follow-up; HIT-6 = Headache Impact Test; IP = investigational product; IVR = interactive voice response; IWR = interactive web response; M = month (end of month x); OLTP = open- label treatment phase; PE = physical exam; per. = period; PK = pharmacokinetics; PROs = Patient-reported Outcomes; QM = monthly; rand. = randomized / randomization; SAE = serious adverse event; SC = subcutaneous; UDS = urine drug screen; Wk = week (end of week x); Wkly = weekly; WOCBP = women of childbearing potential 1 Each study visit during the double-blind treatment phase and safety follow-up has a window of ± 3 consecutive calendar days. The day 1 visit (randomization day) has a window of 0, +7 consecutive calendar days; the day 1 visit must occur 28 to 35 days after the week -4 visit date. Each study visit during the open-label treatment phase has a window of ± 4 consecutive calendar days. All study visit target dates are to be calculated from the day 1 visit date. All study procedures for a given study visit are to be completed on the same day. 2 Sites to access the Interactive Voice Response (IVR) / Interactive Web Response (IWR) System for the following: to enter the subject into the initial screening phase, to randomize an eligible subject, to obtain the investigational product assignment, to enter the subject into the open-label treatment phase, to register the end of investigational product, and to register study early termination or completion. Subject data will be collected in the IVR/IWR System including, but not limited to reason for screen fail (if applicable). Sites to access the IVR/IWR System to obtain the investigational product assignment at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72. The IVR/IWR System will automatically assign investigational product when a subject is randomized at day 1 and when a subject is entered into the open-label treatment phase at week 24. Investigational product is dosed QM, SC. 3 A subject who discontinues the study during the double-blind treatment phase will complete the week 24/early termination (ET) visit. A subject who discontinues open-label investigational product or the study during the open-label treatment phase will complete the week 100/early termination (ET) visit. Subjects also will complete the safety follow-up visit 16 weeks after the last dose of investigational product. 4 Entry into the baseline phase must occur only after completion of initial screening phase procedures 5Enrollment (ie, randomization) into the double-blind treatment phase using the IVR/IWR System must occur only after completion of all baseline phase procedures and prior to the first dose of double-blind investigational product (randomization and administration of the first dose of investigational product should occur on day 1) 6 Entry into the open-label treatment phase using the IVR/IWR System must occur only after completion of all double-blind treatment phase procedures and prior to the first dose of open-label AMG 334 7 Height and weight, measured without shoes. Height to be collected at the initial screening phase visit only. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 40 of 80 8 Systolic/diastolic blood pressure, heart rate and body temperature. Blood pressure to be obtained after the subject has been in a semi-recumbent position (partial semi- Fowler’s position) or supine position in a rested and calm state for at least 5 minutes. At least 2 measurements (separated by at least 5 min) should be made and the average recorded. The position selected for a subject should be used for all blood pressure measurements throughout the study. 9 Pregnancy testing for women of childbearing potential (WOCBP) Note: Additional on treatment pregnancy testing may be performed at the investigator’s discretion or per local laws and regulation. 10 Samples for PK assessment will be serum. 11 PK samples collected at a study visit during which investigational product will be administered should be collected before dosing with investigational product (trough) 12 Only subjects participating in the optional PK substudy (must have provided informed consent for the PK substudy) will have blood samples collected on day 8 and day 64. The PK substudy sampling window is ± 3 consecutive calendar days. 13 For subjects who provided informed consent for the pharmacogenetic studies, DNA will be obtained from the cell pellet collected in the plasma tube used for the biomarker development sample. Therefore, additional sampling is not required. 14 Clinical Outcomes Assessments (COAs) and Patient-reported Outcomes (PROs) to be collected by subjects using eDiaries. The HIT-6 is to be completed during applicable study visits before invasive procedures (eg, blood draws) and investigational product administration. 15 Site study staff to administer investigational product to subjects on day 1 (only after randomization and completion of all day 1 procedures) and at weeks 4, 8, 12, 16, 20, 24 (only after entering the open-label treatment phase and completion of all week 24 procedures), 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, and 96. Investigational product administration should occur after any trough PK sampling. Sites are to record the time of investigational product administration. Following the first 3 doses of investigational product in the double-blind treatment phase (ie, day 1, week 4, week 8), subjects are to remain in the clinic for approximately 1 hour for observation. 16 Serious adverse events are to be collected after signing of the informed consent through end of study (16 weeks after the last dose of investigational product). Non-serious adverse events and adverse device effects (for OLTP only) are to be collected after the first dose of investigational product through end of study (16 weeks after the last dose of investigational product). 17 Current employment status will be collected at D1 (pre-rand.), week 12, week 24, and during the open label phase; the status should be collected retrospectively if needed. 18Visit for Dose Increase to 140 mg and 12Wk Post Increase to 140 mg apply only to subjects in the open-label phase who have not completed W48 after IRB approval of Protocol Amendment 2. 19 Screening must occur 4 weeks prior to the planned start of the CHU substudy (day 1). IVR System will be adjusted to accommodate CHU substudy screening and randomization information as required. 20 Day 1 of the CHU substudy may occur at any visit as long as subject has received at least 1 open-label dose of AMG 334 140 mg in the 20120309 main study. 21 At day 85 of the CHU substudy, subject will receive AMG 334 140 mg SC administered by site staff using PFS formulation and will continue scheduled procedures and assessments as per 20120309 main study. 22 ET: If a subject early terminates the CHU substudy, he/she may receive administration of AMG 334 140 mg SC at the site as per 20120309 main study and will continue 20120309 scheduled procedures and assessments as per 20120309 main study. 23Study coordinator will review AI/pen training materials (Instructions for Use) with subject at screening and will review AI/pen training materials at day 1 of the CHU substudy. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 41 of 80 Section: 7.2.3 Medical and Medication History, Paragraph 1 Add: A review of medical and medication history will be performed at initial screening to confirm subject eligibility and at week 16. Section: 7.2.13 Clinical Outcomes Assessments (COAs) and Electronic Diaries (eDiaries), Paragraph 4 Replace: The subject will be instructed to interact with the eDiary every day during the baseline phase and between the day 1 and week 52 study visits and between the week 72 and week 76/early termination (ET) study visits, and to bring the eDiary to every study visit during these periods. At the day 1 study visit the investigator will use the subject’s eDiary to review all data entered during the baseline phase and confirm the relevant inclusion and exclusion criteria. With: The subject will be instructed to interact with the eDiary every day during the baseline phase and between the day 1 and week 52 study visits, between the week 72 and week 76/ study visits, between the week 96 and week 100/early termination (ET) study visits, and to bring the eDiary to every study visit during these periods. At the day 1 study visit the investigator will use the subject’s eDiary to review all data entered during the baseline phase and confirm the relevant inclusion and exclusion criteria. During these periods the subject will bring the eDiary to every study visit. Section: 7.2.17 Adverse Event, Serious Adverse Event, Adverse Device Effect Collection/Recording/Reporting Add: 7.2.17 Adverse Event, Serious Adverse Event, Adverse Device Effect Collection/Recording/Reporting Adverse event, serious adverse event, and adverse device effect information should be collected throughout the study and recorded at each study visit. Refer to Section 9 for details. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 42 of 80 Section: 7.2.19 Laboratory Assessments, Paragraph 3 Add: Any sample collected according to the Schedule of Assessments (Table 2-Table 4) may be analyzed for any of the tests outlined in the protocol and for any tests necessary to ensure subject safety. Section: 7.2.19 Laboratory Assessments, Paragraph 4 Add: See Table 5 for Analyte Listing (all run by central laboratory, unless otherwise noted as “Amgen/designee” or “local” laboratory. Please refer to the central laboratory manual for the complete listing of analytes run by the central laboratory): Section: 7.2.19 Laboratory Assessments, Table 5 Header Add: Table 5. Analyte Listing Section: 7.2.20 Initial Screening Phase, Bullet 13 Add: Serious adverse event collection/recording/reporting (Note: Serious adverse events are to be collected after signing of the informed consent through 16 weeks after the last dose of investigational product.) Section: 7.2.21.1 Week -4 Visit, Bullet 7 Add: Serious adverse event collection/recording/reporting Section: 7.2.22 Day 1 Visit (Prior to Randomization), Bullet 6 Add: • Employment status Section: 7.2.22 Day 1 Visit (Prior to Randomization), Bullet 8 Add: • Serious adverse event collection/recording/reporting CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 43 of 80 Section: 7.2.23 Day 1 (After Randomization) and the Double-blind Treatment Phase, Bullet 3 Add: • Medical and Medication History Section: 7.2.23 Day 1 (After Randomization) and the Double-blind Treatment Phase, Bullet 17 Add: • Employment status (weeks 12 and 24/end of double-blind treatment phase) Section: 7.2.23 Day 1 (After Randomization) and the Double-blind Treatment Phase, Bullet 20 Add: • Serious and non-serious adverse event collection/recording/reporting. (Note: Serious adverse events are to be collected after signing of the informed consent through 16 weeks after the last dose of investigational product. Non-serious adverse events are to be collected after the first dose of investigational product through 16 weeks after the last dose of investigational product.) Section: 7.2.24 Open-label Treatment Phase, Bullet 15 Add: • Employment status Section: 7.2.24 Open-label Treatment Phase, Bullets 17, 18, 19, and 20 Add: • Administration of open-label AMG 334 70 mg QM SC or 140 mg QM SC. The first dose of open-label investigational product is to be administered only after completion of all week 24 procedures. In general, administration of investigational product should be the last procedure performed at each study visit. • After IRB approval of Protocol Amendment 2, the 24-week double-blind treatment phase is followed by a 76-week OLTP with dose determined by the subject’s week 48 status: • (1) Subjects who have already completed the week 48 visit will continue to receive AMG 334 70 mg QM SC (OL70) for a total of 76 weeks, following the open label assessments in Table 3. • (2) Subjects who have not yet completed the double-blind treatment phase and are not yet in the open-label phase will receive AMG 334 140 mg QM SC (OL140) upon entering the open-label phase and continue receiving open-label AMG 334 140 mg QM SC for 76 weeks. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 44 of 80 • (3) Subjects who have not yet completed the week 48 visit but are in the open-label phase receiving AMG 334 70 mg QM SC must increase their dose to AMG 334 140 mg QM SC and continue receiving open-label AMG 334 140 mg QM SC until the week 100 visit (OL70-140) for a total open label phase duration of 76 weeks. The dose increase should be done at the first available opportunity, defined as the first visit after IRB approval of Protocol Amendment 2. Refer to Table 3 for assessments to be collected at the visit of the dose increase and 12 weeks after the dose increase. At the time of the dose increase, the End of Open Label 70 mg eCRF page will need to be completed as subjects will be transitioning from 70 mg to 140 mg. • Serious and non-serious adverse event collection/recording/reporting. (Note: Serious and non-serious adverse events are to be collected through 16 weeks after the last dose of investigational product) • Adverse device effects collection/recording/reporting Section: 7.2.24 Open-label Treatment Phase, Paragraph 2 Replace: A subject who discontinues open-label investigational product or the study during the open-label treatment phase will complete the week 76/early termination (ET) visit and the safety follow-up visit 16 weeks after the last dose of investigational product. With: A subject who discontinues open-label investigational product or the study during the OLTP will complete the week 100/early termination (ET) visit and the safety follow-up visit 16 weeks after the last dose of investigational product. Section: 7.2.25 Clinical Home Use Substudy (Optional) Add: 7.2.25 Clinical Home Use Substudy (Optional) The following procedures are to be completed during the OLTP at time points designated in the Schedule of Assessments (Table 4). At each CHU substudy visit, any assessments scheduled for the main 20120309 study visit should also be completed. Screening: • Obtain consent to CHU substudy • Review of IFU for AI/pen with subject CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 45 of 80 • Register CHU consent date using the IVR/IWR System (via Additional Product Dispensing activity) • Review for adverse events/adverse device effects/serious adverse events Day 1: • After confirming subject eligibility, the following procedures are to be completed: • Register CHU randomization to randomize the subject to two 70 mg/mL AIs/pens or one 140 mg/mL AI/pen self-administration using the IVR/IWR System (via Additional Product Dispensing activity) − Site to instruct subject on how to self-administer AMG 334 with the AI/pen by reviewing entire IFU − Physical examination of subject with particular attention to any skin abnormalities in areas that might be used for IP self-administration − Subject self-administration using the AI/pen under site supervision − Review for adverse events/adverse device effects/serious adverse events − Product complaint recording (if applicable) − Study coordinator to reconcile IP (AI/pen) Day 28: • Study coordinator dispenses AI/pen to subject for self-administration on day 29 (IP device assigned using the IVR/IWR system via Additional Product Dispensing activity) • Review for adverse events/adverse device effects/serious adverse events • Product complaint recording (if applicable) • Telephone call time scheduled for day 29 (Note, telephone visit must occur after subject has self-administered IP) Day 29: • Subject self-administers AMG 334 using AI/pen in non-clinic setting • Telephone visit with study coordinator to inquire of subject if the subject administered a full, partial, or no dose of AMG 334 • If the subject was not able to administer a full dose of AMG 334, the site staff will inquire further to determine if the subject experienced a device failure or use error that prevented the full-dose administration • Review adverse events/adverse device effects/serious adverse events • Product complaint recording (if applicable) CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 46 of 80 Day 56: • Subject returns IP for Study Coordinator to reconcile IP (AI/pen) • Study coordinator dispenses AI/pen to subject for self-administration on day 57 (IP device assigned using the IVR/IWR system via Additional Product Dispensing activity) • Review for adverse events/adverse device effects/serious adverse events • Product complaint recording (if applicable) • Telephone call time scheduled for day 57 (Note, telephone visit must occur after subject has self-administered IP) Day 57: • Subject self-administers AMG 334 using AI/pen in the non-clinical setting • Telephone visit with study coordinator to inquire of subject if the subject administered a full, partial, or no dose of AMG 334 • If the subject was not able to administer a full dose of AMG 334, the site staff will inquire further to determine if the subject experienced a device failure or use error that prevented the full-dose administration • Review adverse events/adverse device effects/serious adverse events • Product complaint recording (if applicable) Day 85: End of CHU substudy • Subject returns IP for study coordinator to reconcile IP (AI/pen) • Review adverse events/adverse device effects/serious adverse events • Product complaint recording (if applicable) • Subject continues all 20120309 study assessments and IP is administered at site as per the 20120309 protocol Section: 7.2.26 Safety Follow-up / End of Study Visit, Bullet 11 and 12 Add: • Serious and non-serious adverse event collecting/recording/reporting. (Note: Serious and non-serious adverse events are to be collected through 16 weeks after the last dose of investigational product) • Adverse device effect/recording/reporting • Product complaint recording CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 47 of 80 Section: 7.6 Sample Storage and Destruction, Paragraph 1 Add: Any sample collected according to the Schedule of Assessments (Table 2-Table 3) can be analyzed for any of the tests outlined in the protocol and for any tests necessary to minimize risks to study subjects. Section: 8.1 Subjects’ Decision to Withdraw, Paragraph 1 Replace: If this occurs, the investigator is to discuss with the subject the appropriate processes for discontinuation from investigational product and must discuss with the subject the options for continuation of the Schedule of Assessments (Table 3) and collection of data, including endpoints and adverse events. The investigator must document the change to the Schedule of Assessments (Table 3) and the level of follow up that is agreed to by the subject (eg, in person, by telephone/mail, through family/friends, in correspondence/communication with other physicians, from review of the medical records). With: If this occurs, the investigator is to discuss with the subject the appropriate processes for discontinuation from investigational product and must discuss with the subject the options for continuation of the Schedule of Assessments (Table 2-Table 4) and collection of data, including endpoints, adverse events, adverse device effects (if applicable), and serious adverse events. The investigator must document the change to the Schedule of Assessments (Table 2-Table 4) and the level of follow-up that is agreed to by the subject (eg, in person, by telephone/mail, through family/friends, in correspondence/communication with other physicians, from review of the medical records). Section: 9.2.1 Reporting Procedures for Adverse Events and Adverse Device Effects That do not Meet Serious Criteria, Header and Paragraph 1 Replace: 9.2.1 Reporting Procedures for Adverse Events That do not Meet Serious Criteria The investigator is responsible for ensuring that all adverse events observed by the investigator or reported by the subject that occur after the first dose of investigational CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 48 of 80 product through the end of the safety follow-up visit (16 weeks after the last dose of investigational product) are reported using the Event CRF (eg, Adverse Event Summary), including events that are reported to the Event Adjudication Committee for adjudication. With: 9.2.1 Reporting Procedures for Adverse Events and Adverse Device Effects That do not Meet Serious Criteria The investigator is responsible for ensuring that all adverse events and adverse device effects (including the OLTP and CHU substudy) observed by the investigator or reported by the subject that occur after the first dose of investigational product through the end of the safety follow-up visit (16 weeks after the last dose of investigational product) are reported using the Event CRF (eg, Adverse Event Summary), including events that are reported to the Event Adjudication Committee for adjudication. Section: 9.2.1 Reporting Procedures for Adverse Events and Adverse Device Effects That do not Meet Serious Criteria, Paragraph 2, Bullet 4 • Replace: • assessment of relatedness to investigational product (medicine and/or pre-filled syringe), and With: • assessment of relatedness to investigational product (AMG 334 / placebo), and/or the Amgen medical devices (pre-filled syringe or the AI/Pen), and/or study-mandated procedure/study activity, and Section: 9.2.1 Reporting Procedures for Adverse Events and Adverse Device Effects That do not Meet Serious Criteria, Paragraph 3 Replace: The adverse event grading scale used will be the Common Terminology Criteria for Adverse Events (CTCAE). The grading scale used in this study is described in Appendix A. The investigator must assess whether the adverse event is possibly related to the investigational product (medicine and/or pre-filled syringe). This relationship is indicated by a “yes” or “no” response to the question: “Is there a reasonable possibility that the event may have been caused by the investigational product (medicine and/or pre-filled syringe)?” CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 49 of 80 With: The adverse event grading scale used will be the CTCAE. The grading scale used in this study is available at the following location: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. During the double-blind treatment period, the investigator must assess whether the adverse event is possibly related to the investigational medicinal product (AMG 334/placebo). This relationship is indicated by a “yes” or “no” response to the question: “Is there a reasonable possibility that the event may have been caused by the investigational medicinal product (AMG 334/placebo)?” During the OLTP and the CHU substudy, the investigator must assess whether the adverse event is possibly related to AMG 334. This relationship is indicated by a “yes” or “no” response to the question: “Is there a reasonable possibility that the event may have been caused by AMG 334?” During the OLTP and the CHU substudy, the investigator must assess whether the adverse event is possibly related to the prefilled syringe or AI/Pen (investigational medical devices used to administer AMG 334). The relationship is indicated by a “yes” or “no” response to the question: Is there a reasonable possibility that the event may have been caused by the investigational medical devices? The investigator must assess whether the adverse event is possibly related to any study-mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure (including any screening procedure(s)). This relationship is indicated by a “yes” or “no” response to the question: “Is there a reasonable possibility that the event may have been caused by a study activity (eg, administration of investigational product, protocol-required therapies, device(s)), and/or procedure”? Relatedness means that there are facts or reasons to support a relationship between investigational product and the event. Section: 9.2.2 Reporting Procedures for Serious Adverse Events Add: The investigator is responsible for ensuring that all serious adverse events (this includes the CHU substudy) observed by the investigator or reported by the subject that occur after signing of the informed consent through the end of the safety follow-up CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 50 of 80 visit (16 weeks after the last dose of investigational product) are recorded in the subject’s medical record and are submitted to Amgen, including serious adverse events that are reported to the Event Adjudication Committee for adjudication. If the electronic data capture (EDC) system is unavailable to the site staff to report the serious adverse event, the information is to be reported to Amgen via an electronic Serious Adverse Event (eSAE) Contingency Report Form within 24 hours of the investigator’s knowledge of the event. See Appendix B for a sample of the Serious Adverse Event Worksheet/electronic Serious Adverse Event Contingency Report Form. For EDC studies where the first notification of a Serious Adverse Event is reported to Amgen via the eSerious Adverse Event Contingency Report Form, the data must be entered into the EDC system when the system is again available. During the double-blind treatment period, the investigator must assess whether the serious adverse event is possibly related to the investigational medicinal product (AMG 334 / placebo). This relationship is indicated by a “yes” or “no” response to the question: “Is there a reasonable possibility that the event may have been caused by the investigational medicinal product (AMG 334 / placebo)?” During the OLTP and the CHU substudy, the investigator must assess whether the serious adverse event is possibly related to AMG 334. This relationship is indicated by a “yes” or “no” response to the question: “Is there a reasonable possibility that the event may have been caused by AMG 334?” During the OLTP and the CHU substudy, the investigator must assess whether the serious adverse event is possibly related to the prefilled syringe or AI/Pen (investigational medical devices used to administer AMG 334). The relationship is indicated by a “yes” or “no” response to the question: Is there a reasonable possibility that the event may have been caused by the investigational medical devices? The investigator must assess whether the serious adverse event is possibly related to any study-mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure (including any screening procedure(s)). This relationship is indicated by a “yes” or “no” response to the question: “Is there a reasonable possibility that the event may CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 51 of 80 have been caused by a study activity (eg, administration of investigational product, protocol-required therapies, device(s)), and/or procedure”? Relatedness means that there are facts or reasons to support a relationship between investigational product and the event. Section: 9.2.2 Reporting Procedures for Serious Adverse Events (unamended text was moved from Section 9.2.3 to the end of Section 9.2.2) Add: The investigator is expected to follow reported serious adverse events until stabilization or reversibility. New information relating to a previously reported serious adverse event must be submitted to Amgen. All new information for serious adverse events must be sent to Amgen within 24 hours following knowledge of the new information. The investigator may be asked to provide additional follow-up information, which may include a discharge summary or extracts from the medical record. Information provided about the serious adverse event must be consistent with that recorded on the applicable CRF (eg, Adverse Event Summary CRF). If a subject is permanently withdrawn from protocol-required therapies because of a serious adverse event, this information must be submitted to Amgen. To comply with worldwide reporting regulations for serious adverse events, the treatment assignment of subjects who develop serious, unexpected, and related adverse events may be unblinded by Amgen before submission to regulatory authorities. Investigators will receive notification of related serious adverse events reports sent to regulatory authorities in accordance with local requirements. Amgen will report serious adverse events and/or suspected unexpected serious adverse reactions as required to regulatory authorities, investigators/institutions, and IRBs in compliance with all reporting requirements according to local regulations and good clinical practice. The investigator is to notify the appropriate IRB of serious adverse events occurring at the site and other adverse event reports received from Amgen, in accordance with local procedures and statutes. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 52 of 80 Section: 9.2.3 Reporting Serious Adverse Events After the Protocol-required Reporting Period, Paragraph 2 and 3 Delete: If the electronic data capture (EDC) system is unavailable to the site staff to report the serious adverse event, the information is to be reported to Amgen via an electronic Serious Adverse Event (eSAE) Contingency Report Form within 24 hours of the investigator’s knowledge of the event. See Appendix B for a sample of the Serious Adverse Event Worksheet/electronic Serious Adverse Event Contingency Report Form. For EDC studies where the first notification of a Serious Adverse Event is reported to Amgen via the eSerious Adverse Event Contingency Report Form, the data must be entered into the EDC system when the system is again available. The investigator must assess whether the serious adverse event is possibly related to any study-mandated activity or procedure. This relationship is indicated by a “yes” or “no” response to the question: “Is there a reasonable possibility that the event may have been caused by a study activity/procedure?” Section: 9.4 Pregnancy and Lactation Reporting Replace: If a pregnancy occurs in a female subject, or female partner of a male subject, while the subject is taking investigational product, report the pregnancy to Amgen as specified below. In addition to reporting any pregnancies occurring during the study, investigators should monitor for pregnancies that occur through 16 weeks after the last dose of investigational product. The pregnancy should be reported to Amgen’s global Pregnancy Surveillance Program within 24 hours of the investigator’s knowledge of the event of a pregnancy. Report a pregnancy on the Pregnancy Notification Worksheet (Appendix C). The Pregnancy Surveillance Program (PSP) will seek to follow the pregnant woman throughout her pregnancy and her baby up to 12 months after birth. If a lactation case occurs while the female subject is taking protocol-required therapies, report the lactation case to Amgen as specified below. In addition to reporting a lactation case during the study, investigators should monitor for lactation cases that occur 16 weeks after the last dose of investigational product. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 53 of 80 Any lactation case should be reported to Amgen’s global Lactation Surveillance Program (LSP) within 24 hours of the investigator’s knowledge of event. Report a lactation case on the Lactation Notification Worksheet (Appendix D). With: If a female subject becomes pregnant, or a male subject fathers a child, while the subject is taking investigational product/product-required therapies, report the pregnancy to Amgen Global Patient Safety as specified below. In addition to reporting any pregnancies occurring during the study, investigators should report pregnancies that occur through 16 weeks after the last dose of investigational product/protocol-required therapies. The pregnancy should be reported to Amgen Global Patient Safety within 24 hours of the investigator’s knowledge of the event of a pregnancy. Report a pregnancy on the Pregnancy Notification Worksheet (Appendix C). Amgen Global Patient Safety will follow-up with the investigator regarding additional information that may be requested. If a female subject becomes pregnant during the study, the investigator should attempt to obtain information regarding the birth outcome and health of the infant. If the outcome of the pregnancy meets a criterion for immediate classification as a serious adverse event (eg, female subject experiences a spontaneous abortion, stillbirth, or neonatal death or there is a fetal or neonatal congenital anomaly) the investigator will report the event as a serious adverse event. If a female breastfeeds while taking investigational product/protocol-required therapies report the lactation case to Amgen as specified below. Any lactation case should be reported to Amgen Global Patient Safety within 24 hours of the investigator’s knowledge of event. Report a lactation case on the Lactation Notification Worksheet (Appendix D). Amgen Global Patient Safety will follow-up with the investigator regarding additional information that may be requested. In addition to reporting a lactation case during the study, investigators should monitor for lactation cases that occur 16 weeks after the last dose of investigational product/protocol-required therapies. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 54 of 80 If a male subject's female partner becomes pregnant, the investigator should discuss obtaining information regarding the birth outcome and health of the infant from the pregnant partner. Section: 10.1.1.4 Clinical Home Use Substudy Add: 10.1.1.4 Clinical Home Use Substudy 10.1.1.4.1 Primary Endpoint • Subject-reported outcome of attempted full-dose administration on day 29 and day 57 10.1.1.4.2 Secondary Endpoint • Subject incidence of adverse events, serious adverse events, and adverse device effects Section: 10.1.1.5 Definitions of Terms Included in Endpoints, Acute Headache Medication Treatment Day Add: Acute Headache Medication Treatment Day: Any calendar day during which the subject took an acute headache medication (migraine-specific or non-migraine-specific). Section: 10.1.1.5 Definitions of Terms Included in Endpoints, Monthly eDiary Data Replace: Data collected by the eDiary in any 28-consecutive day interval relative to study day 1 when more than 14 days of eDiary data are collected within that 28-consecutive day interval. With: Data collected by the eDiary in any 28-consecutive day interval relative to study day 1 when at least 14 days of eDiary data are collected within that 28-consecutive day interval. Monthly frequency measurements will be prorated to 28-day equivalents. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 55 of 80 Section: 10.1.2 Analysis Sets, Paragraph 1 Replace: The efficacy analysis set includes subjects in the FAS and who received at least one dose of investigational product and completed at least one post-baseline monthly migraine day measurement in the double-blind treatment phase. With: The efficacy analysis set includes subjects in the FAS and who received at least one dose of investigational product and had at least one change from baseline measurement in monthly migraine days during the double-blind treatment phase. Section: 10.1.2 Analysis Sets, Paragraph 1 Replace: For safety endpoints, all randomized subjects who received at least one dose of investigational product (ie, safety analysis set) will be analyzed based on actual treatment received. With: For safety endpoints, all randomized subjects who received at least one dose of investigational product (ie, safety analysis set) will be analyzed according to the randomized treatment unless a subject has received the incorrect dose during the entire double-blind treatment phase. Section: 10.1.2 Analysis Sets, Paragraph 2 Add: All subjects enrolled in the CHU substudy will be included in the CHU substudy analysis set. Section: 10.1.3 Covariates and Subgroups Replace: The primary, secondary efficacy, and selected safety endpoints will be analyzed in the subgroups defined by the stratification factor as well as age (< median vs ≥ median), sex, race, body mass index (BMI; < median vs ≥ median), and duration of disease (< median vs ≥ median). CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 56 of 80 With: The primary, secondary efficacy, and selected safety endpoints will be analyzed in the subgroups defined by the stratification factor as well as baseline monthly migraine days (< 8 days vs ≥ 8 days), prior prophylactic failure status (failed any vs not failed any), and BMI (< median vs ≥ median). Section: 10.2 Sample Size Considerations, Paragraph 2 Add: Clinical Home Use Substudy Approximately 50 subjects will be enrolled in to the CHU substudy. The following assumptions are made based on the minimum sample size of 50 subjects: 5% of subjects per treatment group discontinue IP and 90% of the remaining subjects respond that they administered a full dose. As such, the anticipated distribution of responses per treatment group at a planned visit would be 5% categorized as not attempting due to discontinuing IP, 85.5% responding that they administered a full dose, and 9.5% responding that they did not administer a full dose. The associated 95% confidence interval halfwidths with 25 subjects per group are 8.5%, 13.8%, and 11.5%, respectively. The anticipated 95% confidence interval half width for the difference between treatment groups in the proportion of subjects administering a full dose is 19.5%. The discontinuation rate is expected to be less than 5% and the rate of administering a full dose is expected to be greater than 90%, and therefore these calculations are anticipated to be lower bounds. Calculations were performed using nQuery Advisor 7.0. Section: 10.4.2 Interim Analysis, Paragraph 1 Replace: During the open-label treatment phase of the study, an interim analysis is planned after at least 100 subjects randomized to 70 mg of AMG 334 have completed 52 weeks of treatment with investigational product. With: During the OLTP of the study, an interim analysis is planned after at least 100 subjects randomized to 140 mg of AMG 334 have completed 26 and 52 weeks of treatment with investigational product. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 57 of 80 Section: 10.4.4 Final Analysis, Paragraph 1 Replace: The objective of the final analysis is to evaluate the long-term profile of migraine days and adverse events of AMG 334 in subjects with migraine after the 24-week double-blind treatment phase, 52-week open-label treatment phase, and safety follow up. With: The objective of the final analysis is to evaluate the long-term profile of migraine days and adverse events of AMG 334 in subjects with migraine after the 24-week double-blind treatment phase, OLTP, and safety follow-up. Section: 10.4.4 Final Analysis, Paragraph 2 Replace: Final Analysis activities are commenced based on achieving the End of Trial milestone described in Section 3.5.2. With: Final Analysis activities are commenced based on achieving the End of Trial milestone described in Section 3.6.2. Section: 10.5.1 General Considerations, Paragraph 7 Add: The proportion of subjects who administer a full dose of AMG 334 in home-use will be summarized by treatment group at CHU day 29 and day 57. For all subjects who have not discontinued IP, a subject report of full dose administration will be considered a “yes” response, and a subject report of partial or no dose administered will be considered a “no” response. The proportion of each possible pattern of responses across the 2 visits will also be estimated. Ninety-five percent confidence intervals will be provided for each group and the difference in proportions between the groups. Subject incidence of adverse events, serious adverse events, and adverse device effects will be summarized by system organ class and preferred term for subjects enrolled in the CHU substudies. Details of the analysis of the CHU substudy will be described in a separate Statistical Analysis Plan. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 58 of 80 Section: 10.5.2 Primary Efficacy Endpoint, Paragraph 2 Replace: Sensitivity analyses for the primary endpoint include: (1) the same analysis using the per-protocol analysis set, (2) the last observation carried forward (LOCF) to handle missing data, and (3) the inverse probability weighted (IPW) method using generalized estimate equation (GEE) to handle missing data. With: Sensitivity analyses for the primary endpoint include: (1) the same analysis using the per-protocol analysis set, (2) the last observation carried forward (LOCF) to handle missing data with analysis of covariance (ANCOVA) model, and (3) multiple imputation (MI) with assumptions of missing at random (MAR) and missing not at random (MNAR) to handle missing data. Section: 10.5.3 Secondary Efficacy Endpoints, Paragraph 1 Replace: The odds ratio for each AMG 334 treatment group vs placebo group and associated 95% confidence intervals will be reported. Sensitivity analyses for response include: (1) the same analysis using the per-protocol analysis set, and (2) the logistic regression model adjusting for baseline values where missing values will be imputed as non-responders. With: The odds ratio for each AMG 334 treatment group vs placebo group and associated 95% confidence intervals will be reported. Sensitivity analyses for the binary endpoint include: (1) CHM test using the per-protocol analysis set, and (2) generalized linear mixed model without imputation of missing data, and (3) logistic regression model for each visit after the missing data are imputed as non-responders. Section: 10.5.5 Safety Endpoints, Paragraph 1 Replace: For safety endpoints, all randomized subjects who received at least one dose of investigational product (ie, safety analysis set) will be analyzed based on the actual treatment received. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 59 of 80 With: For safety endpoints, all randomized subjects who received at least one dose of investigational product (ie, safety analysis set) will be analyzed according to the randomized treatment unless a subject has received the incorrect dose during the entire double-blind treatment phase. Section: 10.5.5 Safety Endpoints, Paragraph 3 Replace: Subject incidence rates (double-blind treatment phase) and subject incidence rates adjusted for follow-up time (open-label treatment phase) of all treatment-emergent adverse events will be tabulated by treatment groups and by system organ class and preferred term. With: Subject incidence rates (double-blind treatment phase) and exposure-adjusted subject incidence rates (OLTP) of all treatment-emergent adverse events will be tabulated by treatment groups and by system organ class and preferred term. Section: 10.5.5 Safety Endpoints, Paragraph 4 Replace: The analyses of safety laboratory endpoints will include summary statistics over time by treatment group. Shift tables of the worst on-study safety laboratory toxicity based on grade relative to baseline will be tabulated by treatment group. Subject listing of grades ≥ 3 laboratory toxicities will be provided. Add: The analyses of safety laboratory endpoints will include summary statistics over time by treatment group for selected analytes. Shift tables of the worst on-study safety laboratory toxicity based on grade relative to baseline will be tabulated by treatment group. Section: 12.4 Investigator Responsibilities for Data Collection Add: For subjects who withdraw prior to completion of all protocol-required visits and are unable or unwilling to continue the Schedule of Assessments (Table 2-Table 4), the CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 60 of 80 investigator can search publically available records (where permitted) to ascertain survival status. Section: 12.6 Publication Policy, Paragraph 1 Replace: To coordinate dissemination of data from this study, Amgen encourages the formation of a publication committee consisting of several investigators and appropriate Amgen staff, the governance and responsibilities of which are set forth in a Publication Charter. With: To coordinate dissemination of data from this study, Amgen may facilitate the formation of a publication committee consisting of several investigators and appropriate Amgen staff, the governance and responsibilities of which are set forth in a Publication Charter. Section: 12.6 Publication Policy, Paragraph 2 Add: Authorship of any publications resulting from this study will be determined on the basis of the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (International Committee of Medical Journal Editors, 2013, updated 2014), which states: Section: 13 References, Reference 19 Add: International Committee of Medical Journal Editors. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. 2013, updated 2014. http://www.icmje.org/. Accessed 19 September 2013. Section: 14 Appendices, Appendix A Replace: Appendix A. Additional Safety Assessment Information Adverse Event Grading Scale The Common Terminology Criteria for Adverse Events Version 4 (CTCAE v4) is available at the following location: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 61 of 80 Drug-induced Liver Injury Reporting & Additional Assessments Reporting To facilitate appropriate monitoring for signals of DILI, cases of concurrent AST or ALT and TBL and/or INR elevation according to the criteria specified in Section 6.3 require the following: • The event is to be reported to Amgen as a serious adverse event within 24 hours of discovery or notification of the event (ie, before additional etiologic investigations have been concluded) • The appropriate CRF (eg, Adverse Event CRF) that captures information necessary to facilitate the evaluation of treatment-emergent liver abnormalities is to be completed and sent to Amgen. Other events of hepatotoxicity and potential DILI are to be reported as serious adverse events if they meet the criteria for a serious adverse event defined in Section 9.2.2. Additional Clinical Assessments and Observation All subjects in whom investigational product is withheld (either permanently or conditionally) due to potential DILI as specified in Sections 6.3.1 and 6.3.2 or who experience AST or ALT elevations > 3 x ULN are to undergo a period of “close observation” until abnormalities return to normal or to the subject’s baseline levels. Assessments that are to be performed during this period include: • Repeat AST, ALT, ALP, bilirubin (total and direct), and INR within 24 hours • In cases of TBL > 2x ULN or INR > 1.5, retesting of liver tests, BIL (total and direct), and INR is to be performed every 24 hours until laboratory abnormalities improve Testing frequency of the above laboratory tests may decrease if the abnormalities stabilize or the investigational product has been discontinued AND the subject is asymptomatic. • Initiate investigation of alternative causes for elevated AST or ALT and/or elevated TBL: − Obtain complete blood count (CBC) with differential to assess for eosinophilia − Obtain serum total immunoglobulin IgG, Anti-nuclear antibody (ANA), Anti Smooth Muscle Antibody, and Liver Kidney Microsomal antibody 1 (LKM1) to assess for autoimmune hepatitis − Obtain serum acetaminophen (paracetamol) levels − Obtain a more detailed history of: o Prior and/or concurrent diseases or illness o Exposure to environmental and/or industrial chemical agents CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 62 of 80 o Symptoms (if applicable) including right upper quadrant pain, hypersensitivity-type reactions, fatigue, nausea, vomiting and fever o Prior and/or concurrent use of alcohol, recreational drugs and special diets o Concomitant use of medications (including non-prescription medicines and herbal and dietary supplements), plants, and mushrooms − Obtain viral serologies − Obtain CPK, haptoglobin, LDH, and peripheral blood smear − Perform appropriate liver imaging if clinically indicated • Obtain appropriate blood sampling for pharmacokinetic analysis if this has not already been collected • Obtain hepatology consult (liver biopsy may be considered in consultation with an hepatologist) • Follow the subject and the laboratory tests (ALT, AST, TBL, INR) until all laboratory abnormalities return to baseline or normal. The “close observation period” is to continue for a minimum of 4 weeks after discontinuation of investigational product. The potential DILI event and additional information such as medical history, concomitant medications and laboratory results must be captured in corresponding CRFs. With: Appendix A. Hepatoxicity Stopping Rules: Suggested Actions and Follow-up Assessments and Study Treatment Rechallenge Guidelines Subjects with abnormal hepatic laboratory values (ie, alkaline phosphatase [ALP], aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin [TBL]) and/or international normalized ratio [INR] and/or signs/symptoms of hepatitis (as described below) may meet the criteria for withholding or permanent discontinuation of Amgen investigational product or other protocol-required therapies, as specified in the Guidance for Industry Drug-Induced Liver Injury: Premarketing Clinical Evaluation, July 2009. Criteria for Withholding and/or Permanent Discontinuation of Amgen Investigational Product Therapies Due to Potential Hepatotoxicity The following stopping and/or withholding rules apply to subjects for whom another cause of their changes in liver biomarkers (TBL, INR, and transaminases) has not been identified. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 63 of 80 Important alternative causes for elevated AST/ALT and/or TBL values include, but are not limited to: • Hepatobiliary tract disease • Viral hepatitis (eg, Hepatitis A/B/C/D/E, Epstein-Barr Virus, cytomegalovirus, herpes simplex virus, varicella, toxoplasmosis, and parvovirus) • Right sided heart failure, hypotension, or any cause of hypoxia to the liver causing ischemia • Exposure to hepatotoxic agents/drugs or hepatotoxins, including herbal and dietary supplements, plants, and mushrooms • Heritable disorders causing impaired glucuronidation (eg, Gilbert’s Syndrome, Crigler-Najjar syndrome) and drugs that inhibit bilirubin glucuronidation (eg, indinavir, atazanavir) • Alpha-one antitrypsin deficiency • Alcoholic hepatitis • Autoimmune hepatitis • Wilson’s disease and hemochromatosis • Nonalcoholic fatty liver disease including steatohepatitis (NASH) • Non-hepatic causes (eg, rhabdomylosis, hemolysis) If investigational product is withheld, the subject is to be followed according for possible DILI according to recommendations in the last section of this appendix. Rechallenge may be considered if an alternative cause for impaired liver tests (ALT, AST, ALP) and/or elevated TBL, is discovered and the laboratory abnormalities resolve to normal or baseline (see next section in this appendix). CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 64 of 80 Table 6. Conditions for Withholding and/or Permanent Discontinuation of Amgen Investigational Product and Other Protocol-required Therapies Due to Potential Hepatotoxicity Analyte Temporary Withholding Permanent Discontinuation TBL > 3x ULN > 2x ULN at any time OR INR -- > 1.5x ULN (for subjects not on anticoagulation therapy) OR AND AST/ALT > 8x ULN at any time In the presence of no important > 5x ULN but < 8x ULN for ≥ 2 alternative causes for elevated weeks AST/ALT and/or TBL values > 5x ULN but < 8x ULN and unable > 3x ULN (when baseline was to adhere to enhanced monitoring < ULN) schedule > 3x ULN with clinical signs or symptoms that are consistent with hepatitis (such as right upper quadrant pain/tenderness, fever, nausea, vomiting, and jaundice) OR ALP > 8x ULN at any time -- ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; INR = international normalized ratio; TBL = total bilirubin; ULN = upper limit of normal Criteria for Rechallenge of Amgen Investigational Product Therapies After Potential Hepatotoxicity The decision to rechallenge the subject should be discussed and agreed upon unanimously by the subject, investigator, and Amgen. If signs or symptoms recur with rechallenge, then Amgen investigational product is to be permanently discontinued. Subjects who clearly meet the criteria for permanent discontinuation (as described in Table 6) are never to be rechallenged. CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 65 of 80 Drug-induced Liver Injury Reporting & Additional Assessments Reporting To facilitate appropriate monitoring for signals of DILI, cases of concurrent AST or ALT and TBL and/or INR elevation according to the criteria specified above, require the following: • The event is to be reported to Amgen as a serious adverse event within 24 hours of discovery or notification of the event (ie, before additional etiologic investigations have been concluded) • The appropriate CRF (eg, Adverse Event CRF) that captures information necessary to facilitate the evaluation of treatment-emergent liver abnormalities is to be completed and sent to Amgen. Other events of hepatotoxicity and potential DILI are to be reported as serious adverse events if they meet the criteria for a serious adverse event defined in Section 9.2.2. Additional Clinical Assessments and Observation All subjects in whom investigational product is withheld (either permanently or conditionally) due to potential DILI as specified in Table 6 or who experience AST or ALT elevations > 3 x upper limit of normal (ULN) or 2-fold increases above baseline values for subjects with elevated values before drug are to undergo a period of “close observation” until abnormalities return to normal or to the subject’s baseline levels. Assessments that are to be performed during this period include: • Repeat AST, ALT, ALP, bilirubin (total and direct), and INR within 24 hours • In cases of TBL > 2x ULN or INR > 1.5, retesting of liver tests, BIL (total and direct), and INR is to be performed every 24 hours until laboratory abnormalities improve. • Testing frequency of the above laboratory tests may decrease if the abnormalities stabilize or the investigational product(s) or protocol-required therapies has/have been discontinued AND the subject is asymptomatic. • Initiate investigation of alternative causes for elevated AST or ALT and/or elevated TBL. The following are to be considered depending on the clinical situation: • Complete blood count (CBC) with differential to assess for eosinophilia • Serum total immunoglobulin IgG, anti-nuclear antibody (ANA), anti smooth muscle antibody, and liver kidney microsomal antibody -1 (LKM1) to assess for autoimmune hepatitis • Serum acetaminophen (paracetamol) levels • A more detailed history of: • Prior and/or concurrent diseases or illness • Exposure to environmental and/or industrial chemical agents CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 66 of 80 • Symptoms (if applicable) including right upper quadrant pain, hypersensitivity-type reactions, fatigue, nausea, vomiting and fever • Prior and/or concurrent use of alcohol, recreational drugs and special diets • Concomitant use of medications (including non-prescription medicines and herbal and dietary supplements), plants, and mushrooms • Viral serologies • Creatine phosphokinase (CPK), haptoglobin, lactate dehydrogenase (LDH), and peripheral blood smear • Appropriate liver imaging if clinically indicated • Appropriate blood sampling for pharmacokinetic analysis if this has not already been collected • Hepatology consult (liver biopsy may be considered in consultation with a hepatologist) • Follow the subject and the laboratory tests (ALT, AST, TBL, INR) until all laboratory abnormalities return to baseline or normal or considered stable by the investigator. The “close observation period” is to continue for a minimum of 4 weeks after discontinuation of all investigational product(s) and protocol-required therapies. The potential DILI event and additional information such as medical history, concomitant medications and laboratory results must be captured in the corresponding CRFs CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 67 of 80 Section: 14 Appendices, Appendix B Replace: Appendix B. Sample Serious Adverse Event Report Form CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 68 of 80 CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 69 of 80 CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 70 of 80 CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 71 of 80 CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 72 of 80 With: Appendix B. Sample Serious Adverse Event Contingency Report Form CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 73 of 80 CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 74 of 80 CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 75 of 80 CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 76 of 80 CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 77 of 80 Section: 14 Appendices, Appendix C Replace: CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 78 of 80 With: CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 79 of 80 Section: 14 Appendices, Appendix D Replace: CONFIDENTIAL Product: AMG 334 Protocol Number: 20120309 Date: 05 June 2017 Page 80 of 80 With: CONFIDENTIAL