NCT00852670已完成2 期
Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIa Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800, an S1P1 Receptor Agonist, Administered for 6 Weeks to Subjects With Moderate to Severe Chronic Plaque Psoriasis
Actelion14 个研究点 分布在 5 个国家目标入组 66 人开始时间: 2008年10月最近更新:
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
- 66
- 试验地点
- 14
- 主要终点
- Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit.
研究概览
简要总结
This study will assess the efficacy, safety, and tolerability of ACT-128800 in subjects with moderate to severe plaque psoriasis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females with moderate to severe plaque psoriasis who require systemic treatment and for whom participation in a placebo-controlled study of an investigational drug is justified.
排除标准
- •Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis.
- •Systemic or topical treatments for psoriasis other than emollients.
- •Ongoing bacterial, viral or fungal infections.
- •History or presence of malignancy.
- •Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.
研究组 & 干预措施
A
Experimental
干预措施: ACT-128800 (Drug)
B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit.
时间窗: Baseline to week 6
次要结局
- "Clear - almost clear" Physician Global Assessment (PGA) at Week 6 visit.(Week 6)
研究者
研究点 (14)
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终止
1 期
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