NCT03881059已完成2 期
A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Multiple Doses of BMS-986165 in Subjects With Active Psoriatic Arthritis (PsA)
Bristol-Myers Squibb94 个研究点 分布在 4 个国家目标入组 203 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 94
- 主要终点
- Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16
研究概览
简要总结
The main purpose of study is to assess the dose-response relationship of BMS-986165 (Dose A or Dose B once daily [QD]) at Week 16 in the treatment of participants with active PsA.
详细描述
The study is intended to evaluate the safety and efficacy of BMS-986165 Dose A or B once daily (QD) compared with placebo in adults with active PsA. The primary endpoint is american college of rheumatology (ACR) 20 response at Week 16 (Part A).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Investigative site staff, the Sponsor, and Participant will remain blinded to treatment assignment with the exception of an unblinded pharmacist, an unblinded study drug administrator (Part B), and an unblinded site monitor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with PsA for at least 6 months before screening, and who meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
- •Participants either (i) cannot have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 tumor necrosis factor -inhibitor (TNFi) (TNFi-experienced). Failure is defined as lack of response or loss of response with at least 3 months of therapy with an approved dose of a TNFi, as judged by the investigator. Failure must have occurred at least 2 months prior to Day 1
- •Participants have at least 1 confirmed greater than or equal to (>=) 2 centimeter (cm) lesion of plaque psoriasis at screening
- •Participants have active arthritis as shown by a minimum of >= 3 swollen joints and >= 3 tender joints (66/68 joint counts) at screening and Day 1
- •High sensitivity C-reactive protein (hsCRP) >= 3milligram per liter (mg/L) at screening
- •Women of Childbearing Potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment
排除标准
- •Has non-plaque psoriasis (that is (i.e.), guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at screening or Day 1
- •Has any other autoimmune condition such as rheumatoid arthritis, etc. There are exceptions for inflammatory bowel disease or uveitis as follows: currently active disease is excluded but, a history of no longer active disease for at least 12 months (including not being on medication) is allowed
- •Has active (i.e. currently symptomatic) fibromyalgia
- •History or evidence of active infection and/or febrile illness within 7 days prior to Day 1 (example, bronchopulmonary, urinary, gastrointestinal, etc.)
- •History of recent serious bacterial, fungal, or viral infections requiring hospitalization and intravenous (IV) antimicrobial treatment within 90 days prior to screening, or any infection requiring antimicrobial treatment within 15 days prior to Day 1
- •History of active tuberculosis (TB) prior to screening visit, regardless of completion of adequate treatment
研究组 & 干预措施
Part B: BMS-986165 Dose B + Ustekinumab Placebo
Experimental
干预措施: Ustekinumab Placebo (Other)
Part A: Placebo
Placebo Comparator
干预措施: BMS-986165 Placebo (Other)
Part A: BMS-986165 Dose A
Experimental
干预措施: BMS-986165 Dose A (Drug)
Part A: BMS-986165 Dose B
Experimental
干预措施: BMS-986165 Dose B (Drug)
Part B: Ustekinumab + BMS-986165 Placebo
Experimental
干预措施: BMS-986165 Placebo (Other)
Part B: Ustekinumab + BMS-986165 Placebo
Experimental
干预措施: Ustekinumab (Drug)
Part B: BMS-986165 Dose A + Ustekinumab Placebo
Experimental
干预措施: BMS-986165 Dose A (Drug)
Part B: BMS-986165 Dose A + Ustekinumab Placebo
Experimental
干预措施: Ustekinumab Placebo (Other)
Part B: BMS-986165 Dose B + Ustekinumab Placebo
Experimental
干预措施: BMS-986165 Dose B (Drug)
结局指标
主要结局
Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16
时间窗: 16 weeks after first dose
A participant is considered an ACR 20 responder if the following three conditions are met: 1) ≥ 20% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 20% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 20% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)
次要结局
- Adjusted Change From Baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire(From baseline (day of the first dose) to 16 weeks after first dose)
- Adjusted Change From Baseline in the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) Score(From baseline (day of first dose) to 16 weeks after first dose)
- Adjusted Change From Baseline in Dactylitis Count(From baseline (day of first dose) to 16 weeks after first dose)
- Adjusted Change From Baseline in the Leeds Dactylitis Index (LDI) Basic Score(From baseline (day of first dose) to 16 weeks after first dose)
- Adjusted Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)(From baseline (day of the first dose) to 16 weeks after first dose)
- Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 75 Response(16 weeks after first dose)
- Percentage of Participants Achieving the American College of Rheumatology (ACR) 50 Response at Week 16(16 weeks after first dose)
- Percentage of Participants Achieving the American College of Rheumatology (ACR) 70 Response at Week 16(16 weeks after first dose)
- Percentage of Participants Achieving Low Disease Activity According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)(16 weeks after first dose)
- Percentage of Participants Achieving Remission According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)(16 weeks after first dose)
- Percentage of Participants Achieving Dactylitis Resolution(16 weeks after first dose)
- Adjusted Change From Baseline in Enthesitis by the Leeds Enthesitis Index (LEI)(From baseline (day of first dose) to 16 weeks after first dose)
- Adjusted Change From Baseline in Enthesitis by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index(From baseline (day of first dose) to 16 weeks after first dose)
- Percentage of Participants Achieving Enthesitis Resolution by the Leeds Enthesitis Index (LEI)(16 weeks after first dose)
- Percentage of Participants Achieving Enthesitis Resolution by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index(16 weeks after first dose)
- Percentage of Participants Achieving a Physicians Global Assessment-Fingernails (PGA-F) Score of 0 or 1(16 weeks after first dose)
- Percentage of Participants Achieving Minimal Disease Activity (MDA) Response(16 weeks after first dose)
- Adjusted Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS)(From baseline (day of first dose) to 16 weeks after first dose)
- Adjusted Change From Baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA)(From baseline (day of first dose) to 16 weeks after first dose)
- Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)(16 weeks after first dose)
- Adjusted Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(From baseline (day of first dose) to 16 weeks after first dose)
- Adjusted Change From Baseline in the Mental Component Summary (MCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire(From baseline (day of the first dose) to 16 weeks after first dose)
- Adjusted Change From Baseline in the Psoriatic Arthritis Impact of Disease (PsAID) 12 Score(From baseline (day of the first dose) to 16 weeks after first dose)
- Adjusted Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score(From baseline (day of the first dose) to 16 weeks after first dose)
- Adjusted Change From Baseline in the Work Limitation Questionnaire (WLQ) Score(From baseline (day of the first dose) to 16 weeks after first dose)
- Percentage of Participants Achieving Health Assessment Questionnaire-Disability Index (HAQ-DI) 0.35 Response(16 weeks after first dose)
- Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 90 Response(16 weeks after first dose)
- Change From Baseline in Electrocardiogram (ECG) Results(From baseline (day of first dose) to 16 weeks after first dose)
- Change From Baseline in Electrocardiogram (ECG) Heart Rate(From baseline (day of first dose) to 16 weeks after first dose)
- Change From Baseline in Vital Signs - Diastolic Blood Pressure(From baseline (day of first dose) to 16 weeks after first dose)
- Change From Baseline in Vital Signs - Heart Rate(From baseline (day of first dose) to 16 weeks after first dose)
- Change From Baseline in Vital Signs - Respiratory Rate(From baseline (day of first dose) to 16 weeks after first dose)
- Change From Baseline in Vital Signs - Systolic Blood Pressure(From baseline (day of first dose) to 16 weeks after first dose)
- Change From Baseline in Vital Signs - Temperature(From baseline (day of first dose) to 16 weeks after first dose)
- Change From Baseline in Vital Signs - Weight(From baseline (day of first dose) to 16 weeks after first dose)
研究者
研究点 (94)
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