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Study Protocol NCT0239061 Janssen Research & Development* Clinical Protocol A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus CNTO1275SLE2001; Phase 2a AMENDMENT 3 STELARA® (ustekinumab) *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, Inc; Janssen Infectious Diseases BVBA; Janssen R&D Ireland; 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: 2014-005000-19 Status: Approved Date: 18 January 2017 Prepared by: Janssen Research & Development, LLC EDMS number: EDMS-ERI-89608352, 10.0 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. Approved, 18 January 2017 NCT0239061 Stelara® (ustekinumab) Clinical Protocol CNTO1275SLE2001 Amendment 3 TABLE OF CONTENTS TABLE OF CONTENTS ............................................................................................................................... 2 LIST OF IN-TEXT TABLES AND FIGURES ................................................................................................ 6 PROTOCOL AMENDMENTS....................................................................................................................... 7 SYNOPSIS.................................................................................................................................................. 28 TIME AND EVENTS SCHEDULE .............................................................................................................. 35 ABBREVIATIONS ...................................................................................................................................... 42 1. INTRODUCTION................................................................................................................................ 44 1.1. Background .................................................................................................................................... 45 1.2. Overall Rationale for the Study ...................................................................................................... 45 1.2.1. Scientific Rationale for Use of Anti-IL-12/23p40 Therapy in Systemic Lupus Erythematosus............................................................................................................................ 45 1.2.1.1. Subgroup of Subjects with Active Cutaneous Manifestations of Systemic Lupus Erythematosus......................................................................................................................... 46 1.3. Justification for Dosing Regimen ................................................................................................... 46 2. OBJECTIVES AND HYPOTHESIS ................................................................................................... 48 2.1. Objectives ...................................................................................................................................... 48 2.2. Hypothesis ..................................................................................................................................... 49 3. STUDY DESIGN AND RATIONALE ................................................................................................. 49 3.1. Overview of Study Design.............................................................................................................. 49 3.2. Study Design Rationale.................................................................................................................. 53 4. SUBJECT POPULATION.................................................................................................................. 54 4.1. Inclusion Criteria ............................................................................................................................ 55 4.1.1. Inclusion Criteria Applicable to All Subjects ............................................................................... 55 4.1.2. Additional Inclusion Criteria for the Cutaneous Lupus Substudy ............................................... 61 4.1.3. Inclusion Criteria Applicable to All Subjects Entering into the Study Extension (Week 48 or Week 56 visits) ....................................................................................................................... 61 4.2. Exclusion Criteria ........................................................................................................................... 62 4.3. Prohibitions and Restrictions ......................................................................................................... 66 5. TREATMENT ALLOCATION AND BLINDING................................................................................. 67 5.1. Procedures for Randomization ...................................................................................................... 67 5.2. Blinding .......................................................................................................................................... 68 6. DOSAGE AND ADMINISTRATION .................................................................................................. 69 6.1. IV administration ............................................................................................................................ 69 6.2. SC administration........................................................................................................................... 69 7. TREATMENT COMPLIANCE............................................................................................................ 70 8. CONCOMITANT THERAPY.............................................................................................................. 71 8.1. Immunomodulators ........................................................................................................................ 72 8.2. Antimalarial Medications ................................................................................................................ 72 8.3. Corticosteroid Therapy................................................................................................................... 72 8.4. Nonsteroidal Anti-inflammatory Drugs ........................................................................................... 74 8.5. Anti-hypertensive Medications ....................................................................................................... 74 8.6. Topical Medications ....................................................................................................................... 74 2 Approved, 18 January 2017 NCT0239061 Stelara® (ustekinumab) Clinical Protocol CNTO1275SLE2001 Amendment 3 9. STUDY EVALUATIONS .................................................................................................................... 75 9.1. Study Procedures........................................................................................................................... 75 9.1.1. Overview..................................................................................................................................... 75 9.1.2. Screening Phase ........................................................................................................................ 75 9.1.2.1. Screening Procedures ............................................................................................................. 75 9.1.2.2. Retesting.................................................................................................................................. 76 9.1.2.3. Rescreening............................................................................................................................. 77 9.1.3. Double-Blind Treatment Phase .................................................................................................. 77 9.1.3.1. Week 0/Day of Randomization ................................................................................................ 77 9.1.3.2. Placebo-controlled Treatment Period (Through Week 24)...................................................... 77 9.1.4. Cross-over Treatment (Through Week 40)................................................................................. 77 9.1.5. Study Extension (Week 48/Week 56 through Week 104) .......................................................... 77 9.1.6. Subjects
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