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Protocol (C) I4V-MC-JAIW a Multicenter, Randomized, Double Protocol (c) I4V-MC-JAIW A Multicenter, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety in Adult Patients with Moderate to Severe Atopic Dermatitis NCT03435081 Approval Date: 10-Oct-2019 I4V-MC-JAIW(c) Clinical Protocol Page 1 Protocol I4V-MC-JAIW(c) A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Moderate to Severe Atopic Dermatitis BREEZE-AD5 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 baricitinib (LY3009104), 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. Baricitinib (LY3009104) Study I4V-MC-JAIW is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, outpatient, 113-week study designed to evaluate the efficacy and safety of baricitinib 1-mg and 2-mg in patients with moderate to severe atopic dermatitis. Eli Lilly and Company Indianapolis, Indiana USA 46285 Protocol Electronically Signed and Approved by Lilly on 13 December 2017. Amendment (a) Electronically Signed and Approved by Lilly on 6 July 2018. Amendment (b) Electronically Signed and Approved by Lilly on 1 April 2019. Amendment (c) Electronically Signed and Approved by Lilly on approval date provided below Approval Date: 10-Oct-2019 GMT LY3009104 I4V-MC-JAIW(c) Clinical Protocol Page 2 Table of Contents Section Page Protocol I4V-MC-JAIW(c) A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Moderate to Severe Atopic Dermatitis................................................................................................................1 Table of Contents........................................................................................................................2 1. Synopsis .............................................................................................................................9 2. Schedule of Activities .......................................................................................................13 3. Introduction ......................................................................................................................17 3.1. Background..................................................................................................................17 3.2. Study Rationale............................................................................................................18 3.3. Benefit/Risk Assessment ..............................................................................................18 4. Objectives and Endpoints..................................................................................................21 5. Study Design.....................................................................................................................24 5.1. Overall Design .............................................................................................................24 5.1.1. Period 1: Screening .............................................................................................24 5.1.2. Period 2: Double-Blind Placebo-Controlled Treatment, Weeks 0 to 104 ....................................................................................................25 5.1.3. Period 3: Post-Treatment Follow-Up ...................................................................26 5.2. Number of Participants.................................................................................................27 5.3. End of Study Definition ...............................................................................................27 5.4. Scientific Rationale for Study Design...........................................................................27 5.5. Justification for Dose ...................................................................................................28 6. Study Population...............................................................................................................30 6.1. Inclusion Criteria..........................................................................................................30 6.2. Exclusion Criteria ........................................................................................................33 6.3. Lifestyle Restrictions....................................................................................................39 6.4. Screen Failures.............................................................................................................39 7. Treatments........................................................................................................................40 7.1. Treatments Administered .............................................................................................40 7.1.1. Packaging and Labeling .......................................................................................40 7.2. Method of Treatment Assignment ................................................................................41 7.2.1. Selection and Timing of Doses.............................................................................41 7.3. Blinding .......................................................................................................................41 7.4. Dosage Modification....................................................................................................42 7.5. Preparation/Handling/Storage/Accountability...............................................................42 LY3009104 I4V-MC-JAIW(c) Clinical Protocol Page 3 7.6. Treatment Compliance .................................................................................................42 7.7. Concomitant Therapy...................................................................................................42 7.7.1. Prohibited Medications and Procedures................................................................42 7.7.2. Permitted Medications and Procedures.................................................................44 7.7.3. Rescue Therapy....................................................................................................44 7.8. Treatment after the End of the Study ............................................................................46 7.8.1. Continued Access.................................................................................................46 8. Discontinuation Criteria ....................................................................................................47 8.1. Discontinuation from Study Treatment.........................................................................47 8.1.1. Temporary Interruption from Investigational Product...........................................47 8.1.2. Permanent Discontinuation from Investigational Product .....................................48 8.1.3. Discontinuation of Inadvertently Enrolled Patients...............................................50 8.2. Discontinuation from the Study....................................................................................50 8.3. Lost to Follow-Up........................................................................................................50 9. Study Assessments and Procedures ...................................................................................51 9.1. Efficacy Assessments...................................................................................................51 9.1.1. Primary Efficacy Assessments .............................................................................51 9.1.2. Secondary Efficacy Assessments..........................................................................51 9.1.2.1. Eczema Area and Severity Index scores..........................................................51 9.1.2.2. SCORing Atopic Dermatitis ...........................................................................51 9.1.2.3. Hospital Anxiety Depression Scale .................................................................52 9.1.3. Health Outcomes and Quality-of-Life Measures...................................................52 9.1.3.1. Patient-Oriented Eczema Measure ..................................................................52 9.1.3.2. Itch Numeric Rating Scale ..............................................................................52 9.1.3.3. Atopic Dermatitis Sleep Scale ........................................................................52 9.1.3.4. Skin Pain Numeric Rating Scale .....................................................................52 9.1.3.5. Patient Global Impression of Severity.............................................................53 9.1.3.6. Dermatology
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