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Study Protocol ~ GILEAU CLINICAL STUDY PROTOCOL Study Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Althritis on Background Therapy with Methotrexate Sponsor: Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404 INDNumber: IND 123903 EudraCT Number: 2016-001496-75 Clinical Trials.gov Identifier: TBD Indication: Rheumatoid Arthritis Protocol ID: GS-US-379-1582 Gilead Clinical Name: TomDoan Program Manager: Telephone: PPD Gilead Medical Name: Franziska Matzkies Monitor: Telephone: PPD Fax: PPD Mobile: PPD Protocol Version/Date: Original: 08 April 2016 Amendment 1: 27 Jlme 2016 CONFIDENTIALITY STATEMENT The infonnation contained in this document, pruticularly unpublished data, is the prope1ty or under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, potential investigator, or consultant, for review by you, your staff, and an applicable Institutional Review Board or Independent Ethics Committee. The infmmation is only to be used by you in connection with authorized clinical studies of the investigational dmg described in the protocol. You will not disclose any of the infmmation to others without written authorization from Gilead Sciences, Inc., except to the extent necessa1y to obtain inf01med consent from those persons to whom the dmg may be administered. GS-9876 Protocol GS-US-379-1582 Gilead Sciences, Inc. Amendment 1 TABLE OF CONTENTS TABLE OF CONTENTS ..............................................................................................................................................2 LIST OF IN-TEXT TABLES........................................................................................................................................5 LIST OF IN-TEXT FIGURES ......................................................................................................................................5 PROTOCOL SYNOPSIS ..............................................................................................................................................6 GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS....................................................................12 1. INTRODUCTION ..............................................................................................................................................16 1.1. Background ............................................................................................................................................16 1.2. GS-9876 .................................................................................................................................................17 1.2.1. General Information .............................................................................................................17 1.2.2. Nonclinical Pharmacology and Toxicology .........................................................................17 1.2.3. Clinical Trials of GS-9876 ...................................................................................................19 1.3. Filgotinib................................................................................................................................................20 1.3.1. General Information .............................................................................................................20 1.3.2. Nonclinical Pharmacology, Absorption, Distribution, Metabolism, and Excretion (ADME) and Toxicology.....................................................................................20 1.3.3. Clinical Trials of Filgotinib..................................................................................................22 1.4. Information about Methotrexate.............................................................................................................23 1.5. Rationale for Current Study ...................................................................................................................23 1.6. Rationale for Dose Selection..................................................................................................................24 1.7. Risk/Benefit Assessment for the Study..................................................................................................24 1.8. Compliance ............................................................................................................................................26 2. OBJECTIVES.....................................................................................................................................................27 3. STUDY DESIGN................................................................................................................................................28 3.1. Endpoints ...............................................................................................................................................28 3.2. Study Design ..........................................................................................................................................28 3.3. Study Treatments ...................................................................................................................................29 3.4. Duration of Treatment............................................................................................................................29 3.5. Criteria for Interruption and Discontinuation Criteria............................................................................30 3.5.1. Study drug interruption considerations ................................................................................30 3.5.2. Study drug discontinuation considerations...........................................................................30 3.6. End of Study...........................................................................................................................................32 3.7. Post Study Care......................................................................................................................................32 3.8. Pharmacokinetic (PK) Assessments.......................................................................................................32 3.9. Biomarker Testing..................................................................................................................................32 3.9.1. Biomarker Samples for Optional Future Research...............................................................33 3.9.2. Optional Genomic Research.................................................................................................33 4. SUBJECT POPULATION..................................................................................................................................34 4.1. Number of Subjects and Subject Selection ............................................................................................34 4.2. Inclusion Criteria....................................................................................................................................34 4.3. Exclusion Criteria...................................................................................................................................35 5. INVESTIGATIONAL MEDICINAL PRODUCTS ...........................................................................................38 5.1. Randomization, Blinding and Treatment Codes ....................................................................................38 5.1.1. Procedures for Breaking Treatment Codes...........................................................................38 5.2. Description of GS-9876 and PTM GS-9876 ..........................................................................................38 CONFIDENTIAL Page 2 27 June 2016 GS-9876 Protocol GS-US-379-1582 Gilead Sciences, Inc. Amendment 1 5.2.1. Formulation of GS-9876 and PTM GS-9876 .......................................................................38 5.2.2. Packaging and Labeling of GS-9876 and PTM GS-9876 ....................................................39 5.3. Description of Filgotinib and PTM Filgotinib........................................................................................39 5.3.1. Formulation of Filgotinib and PTM Filgotinib.....................................................................39 5.3.2. Packaging and Labeling of Filgotinib and PTM Filgotinib..................................................39 5.4. Storage and Handling of Study Drugs....................................................................................................40 5.5. Dosage and Administration of Study Drugs...........................................................................................40 5.6. Other Medication Administered.............................................................................................................41 5.7. Prior and Concomitant Medications.......................................................................................................41 5.8. Investigational Medicinal Product Accountability and Disposal or Return ...........................................44 6. STUDY PROCEDURES ....................................................................................................................................45 6.1. Subject Enrollment and Treatment Assignment.....................................................................................45
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