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Study Protocol NCT03381196 Janssen Research & Development * Clinical Protocol A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection who Are at Risk of Developing Complications Protocol 63623872FLZ3002; Phase 3 AMENDMENT 1 JNJ-63623872-ZCD Pimodivir *Janssen Research & Development is a global organization that operates through different legal entities in various countries. Therefore, the legal entity acting as the sponsor for Janssen Research & Development studies may vary, such as, but not limited to Janssen Biotech, Inc.; Janssen Products, LP; Janssen Biologics, BV; Janssen-Cilag International NV; Janssen Pharmaceutica NV; Janssen, Inc; Janssen Sciences Ireland UC; or Janssen Research & Development, LLC. The term “sponsor” is used throughout the protocol to represent these various legal entities; the sponsor is identified on the Contact Information page that accompanies the protocol. This study will be conducted under US Food & Drug Administration IND regulations (21 CFR Part 312). EudraCT NUMBER: 2017-002217-59 Status: Approved Date: 9 February 2018 Prepared by: Janssen Research & Development, a division of Janssen Pharmaceutica NV EDMS number: EDMS-ERI-121910908, 6.0 GCP Compliance: This study will be conducted in compliance with Good Clinical Practice, and applicable regulatory requirements. Confidentiality Statement The information in this document contains trade secrets and commercial information that are privileged or confidential and may not be disclosed unless such disclosure is required by applicable law or regulations. In any event, persons to whom the information is disclosed must be informed that the information is privileged or confidential and may not be further disclosed by them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as privileged or confidential. 1 Status: Approved, Date: 9 February 2018 JNJ-63623872-ZCD Pimodivir Clinical Protocol 63623872FLZ3002 Amendment 1 TABLE OF CONTENTS TABLE OF CONTENTS ............................................................................................................................... 2 LIST OF ATTACHMENTS............................................................................................................................ 4 LIST OF IN-TEXT TABLES AND FIGURES ................................................................................................ 5 PROTOCOL AMENDMENTS....................................................................................................................... 6 SYNOPSIS.................................................................................................................................................... 8 TIME AND EVENTS SCHEDULE .............................................................................................................. 18 ABBREVIATIONS ...................................................................................................................................... 22 DEFINITIONS OF TERMS.......................................................................................................................... 23 1. INTRODUCTION................................................................................................................................ 24 1.1. Background .................................................................................................................................... 24 1.2. Standard-of-care ............................................................................................................................ 31 1.3. Overall Rationale for the Study ...................................................................................................... 31 1.4. Benefits and Risks Management ................................................................................................... 32 1.4.1. Known Benefits of Pimodivir....................................................................................................... 32 1.4.2. Potential Benefits of Pimodivir.................................................................................................... 32 1.4.3. Known Risks of Pimodivir ........................................................................................................... 32 1.4.4. Potential Risks of Pimodivir ........................................................................................................ 33 1.4.5. Overall Benefit/Risk Assessment ............................................................................................... 35 2. OBJECTIVES, ENDPOINTS, AND HYPOTHESIS........................................................................... 36 2.1. Objectives and Endpoints .............................................................................................................. 36 2.1.1. Objectives ................................................................................................................................... 36 2.1.2. Endpoints.................................................................................................................................... 37 2.2. Hypothesis ..................................................................................................................................... 39 3. STUDY DESIGN AND RATIONALE ................................................................................................. 39 3.1. Overview of Study Design.............................................................................................................. 39 3.2. Study Design Rationale.................................................................................................................. 41 4. SUBJECT POPULATION.................................................................................................................. 42 4.1. Inclusion Criteria ............................................................................................................................ 42 4.2. Exclusion Criteria ........................................................................................................................... 45 4.3. Prohibitions and Restrictions ......................................................................................................... 46 5. TREATMENT ALLOCATION AND BLINDING................................................................................. 47 6. DOSAGE AND ADMINISTRATION .................................................................................................. 47 7. TREATMENT COMPLIANCE............................................................................................................ 48 8. PRESTUDY AND CONCOMITANT THERAPY ................................................................................ 49 9. STUDY EVALUATIONS .................................................................................................................... 50 9.1. Study Procedures........................................................................................................................... 50 9.1.1. Overview..................................................................................................................................... 50 9.1.2. Screening Phase ........................................................................................................................ 50 9.1.3. Double-blind Treatment Phase................................................................................................... 51 9.1.4. Post-treatment Phase (Follow-up).............................................................................................. 52 9.2. Efficacy........................................................................................................................................... 53 2 Approved, Date: 9 February 2018 JNJ-63623872-ZCD Pimodivir Clinical Protocol 63623872FLZ3002 Amendment 1 9.2.1. Evaluations ................................................................................................................................. 53 9.2.1.1. Patient-reported Outcomes ..................................................................................................... 53 9.2.1.2. Administration of Patient-reported Outcomes ......................................................................... 55 9.2.1.3. Viral Kinetics (Nasal MT Swabs) ............................................................................................. 55 9.2.2. Efficacy Endpoints ...................................................................................................................... 56 9.3. Resistance Evaluations.................................................................................................................. 56 9.3.1. Viral Sequencing......................................................................................................................... 56 9.3.2. Phenotyping................................................................................................................................ 56 9.4. Pharmacokinetics........................................................................................................................... 56 9.4.1. Evaluations ................................................................................................................................
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