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Protocol I1F-MC-RHCR Protocol I1F-MC-RHCR (b) A 24-Week Multicenter, Randomized, Double-Blind, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Guselkumab in Patients with Moderate-to-Severe Plaque Psoriasis NCT03573323 Approval Date: 07-Dec-2018 I1F-MC-RHCR(b) Clinical Protocol Page 1 Protocol I1F-MC-RHCR(b) A 24-Week Multicenter, Randomized, Double-Blind, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Guselkumab in Patients with Moderate-to-Severe Plaque Psoriasis Confidential Information The information contained in this document is confidential and is intended for the use of clinical investigators. It is the property of Eli Lilly and Company or its subsidiaries and should not be copied by or distributed to persons not involved in the clinical investigation of ixekizumab (LY2439821), unless such persons are bound by a confidentiality agreement with Eli Lilly and Company or its subsidiaries. Note to Regulatory Authorities: This document may contain protected personal data and/or commercially confidential information exempt from public disclosure. Eli Lilly and Company requests consultation regarding release/redaction prior to any public release. In the United States, this document is subject to Freedom of Information Act (FOIA) Exemption 4 and may not be reproduced or otherwise disseminated without the written approval of Eli Lilly and Company or its subsidiaries. Ixekizumab (LY2439821) Eli Lilly and Company Indianapolis, Indiana USA 46285 Protocol Electronically Signed and Approved by Lilly on date provided below. Approval Date: 07-Dec-2018 GMT LY2439821 I1F-MC-RHCR(b) Clinical Protocol Page 2 Table of Contents Section Page Protocol I1F-MC-RHCR(b) A 24-Week Multicenter, Randomized, Double-Blind, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Guselkumab in Patients with Moderate-to-Severe Plaque Psoriasis...................................................................................1 Table of Contents........................................................................................................................2 1. Synopsis .............................................................................................................................9 2. Schedule of Activities .......................................................................................................12 3. Introduction ......................................................................................................................17 3.1. Study Rationale............................................................................................................17 3.2. Background..................................................................................................................17 3.3. Benefit/Risk Assessment ..............................................................................................19 4. Objectives and Endpoints..................................................................................................21 5. Study Design.....................................................................................................................23 5.1. Overall Design .............................................................................................................23 5.1.1. Screening Period (Period 1)..................................................................................24 5.1.2. Induction Dosing Period (Period 2) ......................................................................25 5.1.3. Extension Period (Period 3)..................................................................................25 5.1.4. Post-Treatment Follow-Up Period (Period 4) .......................................................25 5.2. Number of Participants.................................................................................................26 5.3. End of Study Definition ...............................................................................................26 5.4. Scientific Rationale for Study Design...........................................................................26 5.5. Justification for Dose ...................................................................................................27 6. Study Population...............................................................................................................28 6.1. Inclusion Criteria..........................................................................................................28 6.2. Exclusion Criteria ........................................................................................................29 6.2.1. Rationale for Exclusion of Certain Study Candidates ...........................................33 6.3. Lifestyle Restrictions....................................................................................................34 7. Treatments........................................................................................................................35 7.1. Treatments Administered .............................................................................................35 7.1.1. Administration of Ixekizumab, Guselkumab and Placebo.....................................36 7.1.2. Observations after Study Drug Administration.....................................................37 7.1.3. Packaging and Labelling ......................................................................................37 7.2. Method of Treatment Assignment ................................................................................37 7.3. Screen Failures.............................................................................................................38 LY2439821 I1F-MC-RHCR(b) Clinical Protocol Page 3 7.3.1. Selection and Timing of Doses.............................................................................38 7.4. Blinding .......................................................................................................................38 7.5. Dosage Modification....................................................................................................39 7.6. Preparation/Handling/Storage/Accountability...............................................................39 7.7. Treatment Compliance .................................................................................................39 7.8. Concomitant Therapy...................................................................................................40 7.9. Treatment after the End of the Study ............................................................................43 7.9.1. Treatment after Study Completion........................................................................43 7.9.2. Special Treatment Considerations ........................................................................43 8. Discontinuation Criteria ....................................................................................................45 8.1. Discontinuation from Study drug..................................................................................45 8.1.1. Permanent Discontinuation from Study drug ........................................................45 8.1.2. Discontinuation of Inadvertently Enrolled Patients...............................................46 8.2. Discontinuation from the Study....................................................................................46 8.3. Lost to Follow-Up........................................................................................................47 9. Study Assessments and Procedures ...................................................................................48 9.1. Efficacy Assessments...................................................................................................48 9.1.1. Primary Efficacy Assessments .............................................................................48 9.1.1.1. Psoriasis Area and Severity Index...................................................................48 9.1.2. Major Secondary Efficacy Assessments ...............................................................48 9.1.2.1. Static Physician Global Assessment................................................................48 9.1.3. Other Efficacy Assessments .................................................................................48 9.1.3.1. Percentage of Body Surface Area ...................................................................48 9.1.3.2. Physician’s Global Assessment of Disease Activity Visual Analog Scale (for Patients with PsA) ...................................................49 9.1.3.3. PGA-F Physician’s Global Assessment of Fingernail Psoriasis .........................................................................................................49 9.1.4. Health Outcome Endpoints...................................................................................49 9.1.4.1. Itch Numeric Rating Scale ..............................................................................49 9.1.4.2. Skin Pain Visual Analog Scale .......................................................................49 9.1.4.3. Patient’s Global Assessment of Disease Severity............................................49 9.1.4.4. Dermatology Life Quality Index .....................................................................49 9.1.4.5. Patient’s Assessment of Pain Visual Analog Scale (for Patients with PsA) ..........................................................................................50 9.1.4.6.
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