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Protocol (E) I4V-MC-JAIN a Phase 3, Multicenter, Double-Blind Protocol (e) I4V-MC-JAIN A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination with Topical Corticosteroids in Adult Patients with Moderate-to-Severe atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contradiction to Cyclosporine NCT03428100 Approval Date: 06-Dec-2019 I4V-MC-JAIN(e)Clinical Protocol Page 1 Protocol I4V-MC-JAIN(e) A Phase3,Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinibin Combination with Topical Corticosteroids in Adult Patients with Moderate-to-Severe Atopic Dermatitis WhoHave Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to,Cyclosporine BREEZE-AD4 EUDRA CTA 2017-004574-34 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 clinicalinvestigation 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) Exemption4 and may not be reproduced or otherwise disseminated without the written approval of Eli Lilly and Company or its subsidiaries. Baricitinib (LY3009104) Eli Lilly and Company Indianapolis, Indiana USA 46285 ProtocolElectronicallySigned andApprovedby Lilly on 09-Nov-2017 Amendment (a) Electronically Signed and Approved by Lilly on 15-Dec-2017 Amendment (b) Electronically Signed and Approved by Lilly on 01 Oct 2018 Amendment (c) Electronically Signed and Approved by Lilly on 09 May 2019 Amendment (d) Electronically Signed and Approved by Lilly on 30 Sep 2019 Amendment (e) Electronically Signed and Approved by Lilly on date provided below Approval Date: 06-Dec-2019 GMT LY3009104 I4V-MC-JAIN(e) Clinical Protocol Page 2 Table of Contents Section Page Protocol I4V-MC-JAIN(e) A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination with Topical Corticosteroids in Adult Patients with Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine BREEZE-AD4.....................................................1 Table of Contents........................................................................................................................2 1. Synopsis .............................................................................................................................9 2. Schedule of Activities .......................................................................................................16 3. Introduction ......................................................................................................................23 3.1. Background..................................................................................................................23 3.2. Benefit/Risk Assessment ..............................................................................................24 3.3. Study Rationale............................................................................................................25 4. Objectives and Endpoints..................................................................................................27 5. Study Design.....................................................................................................................30 5.1. Overall Design .............................................................................................................30 5.1.1. Period 1: Screening and Baseline Period .............................................................32 5.1.2. Period 2: Double-Blind Placebo-Controlled Treatment........................................33 5.1.3. Period 3: Double-Blind, Long-Term Extension ...................................................33 5.1.3.1. Randomized Downtitration Substudy at Week 52 ...........................................33 5.1.3.2. Patients Not Eligible for the Substudy ............................................................34 5.1.4. Period 4: Bridging Extension ...............................................................................35 5.1.5. Period 5: Post-Treatment Follow-Up ...................................................................35 5.2. Number of Participants.................................................................................................36 5.3. End of Study Definition ...............................................................................................36 5.4. Scientific Rationale for Study Design...........................................................................36 5.5. Justification for Dose ...................................................................................................37 5.5.1. Rationale for Dose Adjustment for Renal Impairment ..........................................38 6. Study Population...............................................................................................................39 6.1. Inclusion Criteria..........................................................................................................39 6.2. Exclusion Criteria ........................................................................................................42 6.3. Lifestyle Restrictions....................................................................................................48 6.4. Screen Failures.............................................................................................................48 7. Treatments ........................................................................................................................49 7.1. Treatments Administered .............................................................................................49 LY3009104 I4V-MC-JAIN(e) Clinical Protocol Page 3 7.1.1. Packaging and Labeling .......................................................................................49 7.2. Method of Treatment Assignment ................................................................................50 7.2.1. Selection and Timing of Doses.............................................................................50 7.2.2. Dose Adjustment for Renal Impairment ...............................................................50 7.3. Blinding .......................................................................................................................51 7.4. Dosage Modification....................................................................................................51 7.5. Preparation/Handling/Storage/Accountability...............................................................51 7.6. Treatment Compliance .................................................................................................51 7.7. Concomitant Therapy...................................................................................................52 7.7.1. Permitted Medications and Procedures.................................................................52 7.7.2. Use of Topical Corticosteroids .............................................................................53 7.7.3. Use of Antihistamines ..........................................................................................54 7.7.4. Prohibited Medications and Procedures................................................................56 7.7.5. Rescue Therapy....................................................................................................57 7.7.5.1. Rescue during Period 2: Week 0 (Visit 2) up to Week 52 (Visit 14) ........................................................................................................57 7.7.5.2. Rescue during Periods 3 and 4: from Week 52 (Visit 14) to Week 200 (Visit 28) ...................................................................................58 7.8. Treatment after the End of the Study ............................................................................58 8. Discontinuation Criteria ....................................................................................................59 8.1. Discontinuation from Study Treatment.........................................................................59 8.1.1. Temporary Interruption of Investigational Product ...............................................59 8.1.2. Permanent Discontinuation from Investigational Product .....................................60 8.1.3. Discontinuation of Inadvertently Enrolled Patients...............................................61 8.2. Discontinuation from the Study....................................................................................62 8.3. Lost to Follow-Up........................................................................................................62 9. Study Assessments and Procedures ...................................................................................63 9.1. Efficacy Assessments...................................................................................................63
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