EUCTR2013-003275-36-GR进行中（未招募）1 期
A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Subjects with Chronic Plaque Psoriasis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 217
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Adult subjects with clinical diagnosis of chronic plaque psoriasis (with a disease duration of at least 6 months) and at least 1 fingernail with nail psoriasis.
- •2. Subject must have BSA = 10% and a target fingernail mNAPSI = 8 at Baseline, OR BSA = 5%, a target fingernail mNAPSI = 8 and a total mNAPSI score of = 20 at Baseline
- •3. Subject must have a Nail Psoriasis Physical Functioning Severity score of > 3, OR a Nail Psoriasis Pain NRS score of >3
- •4. Subject must have a Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and and Physician's Global Assessment of Skin Psoriasis (PGA-S) of at least moderate.
- •5. Subject must have discontinued use of all systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis for at least 4 weeks prior to Baseline. Ustekinumamb must have been discontinued at least 12 weeks prior to Baseline.
- •6. NAPSI score of >0 from the proximal half of subject’s target fingernail.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Prior adalimumab therapy.
- •2. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis
- •3. Recent infection requiring treatment
- •4. Significant medical events or conditions that may put patients at risk for participation, including recent history of drug or alcohol abuse
- •5. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
- •6. History of cancer, except successfully treated skin cancer
研究者
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