2023-506256-25-00招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Psoriatic Arthritis who are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 326
- 试验地点
- 75
- 主要终点
- Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response at Week 16
研究概览
简要总结
To compare the efficacy of deucravacitinib to placebo in the treatment of participants with active PsA
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening
- •Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening
- •Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening
- •Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1
- •Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening
- •≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading
排除标准
- •Nonplaque psoriasis at screening or day 1
- •Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease,multiple sclerosis, or vasculitis
- •History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease)
- •Active fibromyalgia
- •Received an approved or investigational biologic therapy for the treatment of PsA or PsO
- •Participant has received a JAK inhibitor for the treatment of PsA and/or PsO.
研究组 & 干预措施
deucravacitinib
Experimental
Participants receiving deucravacitinib
干预措施: deucravacitinib (Drug)
结局指标
主要结局
Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response at Week 16
Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response at Week 16
次要结局
- Change from baseline in DAS28-CRP score at Week 16
- Change from baseline in HAQ-DI score at Week 16
- Proportion of participants meeting PASI 75 response at Week 16, in participants with at least 3% BSA involvement AND at least sPGA 2 at baseline
- Change from baseline in the SF-36 PCS score at Week 16
- Proportion of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at baseline by LEI at Week 16
- Proportion of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: a) Tender joint count ≤ 1 b) Swollen joint count ≤ 1 c) PASI ≤ 1 or BSA ≤ 3% d) Patient assessment of PsA pain ≤ 15 e) Patient Global Assessment of PsA disease activity ≤ 20 f) HAQ-DI ≤ 0.5 g) Tender enthesial points ≤ 1
- Change from baseline in FACIT-Fatigue score at Week 16
- Proportion of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count ≥ 1 at baseline
- Change from baseline in PsA-modified SvdH score at Week 16
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (75)
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