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Efficacy and Safety of Guselkumab, an Anti–Interleukin 23 Monoclonal

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Efficacy and Safety of Guselkumab, an Anti–Interleukin 23 Monoclonal Janssen Pharmaceutical K.K. Clinical Protocol A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL-23 Monoclonal Antibody, following Subcutaneous Administration in Subjects with Palmoplantar Pustulosis Protocol CNTO1959PPP2001; Phase 2 CNTO 1959 Status: Approved Date: 7 Feb 2013 Prepared by: Janssen Pharmaceutical K.K. Document No.: EDMS- ERI-50537544 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 Approved, Date: 7 February 2013 Downloaded From: https://jamanetwork.com/ on 09/26/2021 2 Approved, Date: 7 February 2013 Downloaded From: https://jamanetwork.com/ on 09/26/2021 CNTO 1959 Clinical Protocol CNTO1959PPP2001 TABLE OF CONTENTS TABLE OF CONTENTS ............................................................................................................................... 3 LIST OF ATTACHMENTS ............................................................................................................................ 5 LIST OF IN-TEXT TABLES AND FIGURES ................................................................................................ 5 SYNOPSIS .................................................................................................................................................... 6 TIME AND EVENTS SCHEDULE .............................................................................................................. 10 ABBREVIATIONS ...................................................................................................................................... 12 1. INTRODUCTION ................................................................................................................................ 14 1.1. Background .................................................................................................................................... 14 1.2. Overall Rationale for the Study ...................................................................................................... 17 2. OBJECTIVES AND HYPOTHESIS ................................................................................................... 18 2.1. Objectives ...................................................................................................................................... 18 2.2. Hypothesis ..................................................................................................................................... 19 3. STUDY DESIGN AND RATIONALE ................................................................................................. 19 3.1. Overview of Study Design .............................................................................................................. 19 3.2. Study Design Rationale .................................................................................................................. 20 4. SUBJECT POPULATION .................................................................................................................. 22 4.1. Inclusion Criteria ............................................................................................................................ 22 4.2. Exclusion Criteria ........................................................................................................................... 25 4.3. Prohibitions and Restrictions ......................................................................................................... 28 5. TREATMENT ALLOCATION AND BLINDING ................................................................................. 29 6. DOSAGE AND ADMINISTRATION .................................................................................................. 30 7. TREATMENT COMPLIANCE ............................................................................................................ 31 8. PRESTUDY AND CONCOMITANT THERAPY ................................................................................ 31 8.1. Prestudy Therapy ........................................................................................................................... 31 8.2. Concomitant Therapy ..................................................................................................................... 31 9. STUDY EVALUATIONS .................................................................................................................... 33 9.1. Study Procedures ........................................................................................................................... 33 9.1.1. Overview ..................................................................................................................................... 33 9.1.2. Screening Period ........................................................................................................................ 34 9.1.3. Double-blind Period .................................................................................................................... 35 9.1.4. Safety follow-up after Early Termination ..................................................................................... 36 9.2. Efficacy ........................................................................................................................................... 36 9.2.1. Evaluations ................................................................................................................................. 36 9.2.1.1. Palms and Sole Skin Lesion Evaluations ................................................................................ 36 9.2.1.1.1. Palmoplantar Pustulosis Severity Index (PPSI) ................................................................... 36 9.2.1.1.2. Palmo-Plantar Pustulosis Area and Severity Index (PPPASI) ............................................. 36 9.2.1.1.3. Physician’s Global Assessment of palmoplantar pustulosis lesion (PGA) .......................... 36 9.2.1.1.4. Physician’s Assessment of each skin lesion (PA–pustule, PA–vesicle, PA–nail) ............... 36 9.2.1.1.5. Patient’s Visual Analogue Scale assessment of Palmoplantar Pustulosis Severity (Patient’s VAS-PPP severity) ............................................................................................... 36 9.2.1.2. Pustulotic Arthro-Osteitis Evaluations ..................................................................................... 37 3 Approved, Date: 7 February 2013 Downloaded From: https://jamanetwork.com/ on 09/26/2021 CNTO 1959 Clinical Protocol CNTO1959PPP2001 9.2.1.2.1. Physician’s Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity (Physician’s VAS-PAO activity) ............................................................................................ 37 9.2.1.2.2. Patient’s Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity and Pain (Patient’s VAS-PAO activity, Patient’s VAS-PAO pain) ........................................ 37 9.2.1.3. Quality of Life evaluations ....................................................................................................... 37 9.2.1.3.1. Dermatology Life Quality Index (DLQI) ................................................................................ 37 9.2.1.3.2. SF-36 .................................................................................................................................... 37 9.2.1.4. Other ........................................................................................................................................ 37 9.2.2. Endpoints .................................................................................................................................... 38 9.3. Pharmacokinetics and Immunogenicity ......................................................................................... 38 9.3.1. Evaluations ................................................................................................................................. 38 9.3.2. Analytical Procedures ................................................................................................................. 39 9.3.3. Pharmacokinetic Parameters ..................................................................................................... 39 9.3.4. Immunogenicity Assessments .................................................................................................... 39 9.4. Biomarkers ..................................................................................................................................... 39 9.5. Safety Evaluations ......................................................................................................................... 40 9.6. Sample Collection and Handling .................................................................................................... 42 10. SUBJECT COMPLETION/WITHDRAWAL ......................................................................................
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