CTIS2023-506257-37-00招募中1 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Psoriatic Arthritis (PsA) who are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or had Previously Received TNFa Inhibitor Treatment - IM011-055
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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
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, rheumatoidarthritis, ankylosing spondylitis, Lyme disease), Active fibromyalgia, Received an approved or investigational biologic therapy for the treatment of PsA or PsO
研究者
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