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Clinical Trial Protocol TITLE PAGE Clinical Trial Protocol TITLE PAGE Document Number: c03484701-03 EudraCT No.: 2015-002619-14 BI Trial No.: 1199.36 BI Investigational Nintedanib (Ofev®) Product: INSTAGETM: A 24-week, double-blind, randomized, parallel- Title: group study evaluating the efficacy and safety of oral nintedanib co-administered with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment Efficacy and safety of nintedanib co-administered with Brief Title: sildenafil in IPF patients with advanced lung function impairment Clinical Phase: III b Trial Clinical Monitor: Phone : Fax : Coordinating Investigator: Phone ext (Division), (Clinic) Fax Status: Revised Protocol based on Global Amendment 2 Version and Date: Version: Date: 3.0 18 AUG 2016 Page 1 of 100 Proprietary confidential information. 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission. Boehringer Ingelheim 18 Aug 2016 BI Trial No.: 1199.36 c03484701-03 Trial Protocol Page 2 of 100 Proprietary confidential information © 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies CLINICAL TRIAL PROTOCOL SYNOPSIS Name of company: Boehringer Ingelheim Name of finished product: Ofev® Name of active ingredient: Nintedanib Revision date: Protocol date: Trial number: 18 Aug 2016 30 Dec 2015 1199.36 Title of trial: INSTAGETM: A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib co- administered with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment Coordinating Investigator: Phone ext (Division), (Clinic) Fax Trial sites: Multi-centre trial Clinical phase: III b Objective(s): To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in IPF patients with advanced lung function impairment. Methodology: Double-blind, randomized, parallel design comparison of nintedanib 150 mg bid and sildenafil 20 mg tid to nintedanib 150 mg bid and placebo matching sildenafil tid over 24 weeks No. of patients: total entered: 250 patients each treatment: Randomization 1:1 125 patients assigned to each treatment arm. Diagnosis : Idiopathic Pulmonary Fibrosis (IPF) Main criteria Written informed consent; for inclusion: Boehringer Ingelheim 18 Aug 2016 BI Trial No.: 1199.36 c03484701-03 Trial Protocol Page 3 of 100 Proprietary confidential information © 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies Name of company: Boehringer Ingelheim Name of finished product: Ofev® Name of active ingredient: Nintedanib Revision date: Protocol date: Trial number: 18 Aug 2016 30 Dec 2015 1199.36 Male or female patients aged ≥ 40 years at visit 1; IPF diagnosis based upon the ATS/ERS/JRS/ALAT 2011 guideline for < 6 years; confirmation of diagnosis by investigator based on chest HRCT performed within 18 months of visit 1 and surgical lung biopsy (if available); DLCO (corrected for Hb) ≤ 35% predicted of normal at visit 1 Test product(s): Nintedanib and sildenafil dose: Nintedanib: 300 mg daily (150 mg bid) with possibility to reduce to 200 mg daily (100 mg bid) to manage adverse events Sildenafil: 60 mg daily (20 mg tid) mode of administration: p.o. Comparator products: Nintedanib and placebo matching sildenafil dose: Nintedanib: 300 mg daily (150 mg bid) with possibility to reduce to 200 mg daily (100 mg bid) to manage adverse events Placebo matching sildenafil: Not applicable mode of administration: p.o. Duration of treatment: 24 weeks of randomized treatment Endpoints Primary Endpoint: Change from baseline in SGRQ total score at week 12 Secondary Endpoints: Change from baseline in dyspnea using UCSD SOBQ at week 12; Change from baseline in SGRQ total score at week 24; Change from baseline in dyspnea using UCSD SOBQ at week 24; Boehringer Ingelheim 18 Aug 2016 BI Trial No.: 1199.36 c03484701-03 Trial Protocol Page 4 of 100 Proprietary confidential information © 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies Name of company: Boehringer Ingelheim Name of finished product: Ofev® Name of active ingredient: Nintedanib Revision date: Protocol date: Trial number: 18 Aug 2016 30 Dec 2015 1199.36 Percentage of patients with on-treatment SAEs from baseline to week 24. Safety criteria: Adverse events (especially SAE and other significant AE), physical examination including weight, 12 lead electrocardiogram and vital signs, laboratory evaluations. Statistical methods: Mixed Effects Model for Repeated Measures (MMRM) for continuous endpoints and Kaplan-Meier and Cox model for time to event endpoints, Cochran-Mantel-Haenszel test for binary endpoints Boehringer Ingelheim 18 Aug 2016 BI Trial No.: 1199.36 c03484701-03 Trial Protocol Page 5 of 100 Proprietary confidential information © 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies FLOW CHART Follow Screening Trial Periods Randomized Treatment Period -up Period period Dose Early Visit 11 214 3 4 5 6 715 Adjustment FUP18 EOT17 visit16 Weeks 0 4 8 12 18 24 +4 Days -28 to -1 1 29 57 85 127 169 +28 ±3 ±3 ±3 ±7 ±7 +7 Time window for visits none days days days days days days Informed consent2 X Demographics X Medical history X SGRQ, UCSD-SOBQ, EQ- XXXX X 5D3 Physical examination4 XXXXXXXXXX Vital signs XXXXXXXXXX Laboratory tests XXXXXXXXX Pregnancy test (urine)7 XXXXXXX XX 12 lead-ECG X XXX X Spirometry XXXXXXX X DLCO, VA8 X XX X Resting SpO2 XXXX X 9 Resting PaO2 and PaCO2 X XX X Echocardiogram X Review of in-/exclusion XX criteria Randomization X Access IRT XXXXXXXX Dispense trial drugs XXXX X Collect trial drugs & XXXX10 XXX compliance check Dispense or review patient XXX XXXXX diary11 Adverse events X12 XXXXXXXXX Acute exacerbations XXXXXXXXXX Concomitant therapy XXXXXXXXXX Completion of patient X participation Vital status collection13 X Boehringer Ingelheim 18 Aug 2016 BI Trial No.: 1199.36 c03484701-03 Trial Protocol Page 6 of 100 Proprietary confidential information © 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies 1. The period between visit 1 and 2 should last a maximum of 28 days. Eligible patients can be randomized once central lab results have been received and are found to be consistent with eligibility criteria. 2. At site discretion, informed consent may be obtained on one day and the remainder of the screening procedures can follow. 3. SGRQ, UCSD-SOBQ and EQ-5D are to be completed in this order and prior to any other trial related procedures. 4. Physical examination to include weight measurement at all visits. At visit 1, height measurement should be included. 7. Urine dipstick pregnancy tests will be provided by central lab and should be performed in all women of childbearing potential. If urine test is not acceptable to local authorities, a blood test can be done at a local laboratory. 8. The DLCO/VA assessment should always be performed after the FVC assessment. 9. Arterialised blood gases (PaO2 and PaCO2) will be measured at selected sites experienced in earlobe blood gas sampling. 10. At visit 6 drug supplies should be collected for accountability and compliance check and re-dispensed to the patient. 11. Patient diary will be issued at visit 2 until visit 7. Diary to be reviewed with patient at every visit. Content to be discussed as it pertains to AEs, concomitant therapy, medication compliance and drug administration preceding PK sampling. 12. Adverse events should only be collected at this visit if occurring after obtaining the informed consent. Medical conditions present at time of the informed consent should be recorded in the medical history. 13. Patients who complete an early End of Treatment visit and don’t accept to attend all remaining planned visits will be contacted for vital status collection at week 24. This can be done by phone. 14. Visit 2 is defined as baseline assessment if the respective parameter is planned to be collected at that visit. Otherwise, visit 1 will serve as baseline assessment. 15. Visit 7 is the End of Treatment (EOT) visit for patients who complete the treatment period as planned. 16. In case of dose change of nintedanib (reduction or re-escalation), dose adjustment visit must be conducted to allow dispensing of new medication kit. 17. Early end of treatment visit to be completed for all patients who withdraw or discontinue all study drugs prematurely. These patients will be invited to attend all remaining visits as planned until week 24 (Visit 7). The following procedures are no longer required in the visits to be conducted after the early EOT visit: laboratory tests, biomarker sampling, pharmacokinetic sampling and ECG. 18. A follow up visit needs to be completed 28 days (+7 days) after the last drug administration for all patients. Patients who prematurely discontinue all study drugs but accept to conduct all remaining study visits as planned and the remaining duration in the trial is longer than 28 days after the last drug administration are exempted from this visit. Boehringer Ingelheim 18 Aug 2016 BI Trial No.: 1199.36 c03484701-03 Trial Protocol Page 7 of 100 Proprietary confidential information © 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies
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