NCT01208090已完成2 期
Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety & Tolerability of Two Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered up to Twenty-eight Weeks in Patients With Moderate to Severe Chronic Plaque Psoriasis
Actelion67 个研究点 分布在 10 个国家目标入组 326 人开始时间: 2010年10月31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
- 326
- 试验地点
- 67
- 主要终点
- Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.
研究概览
简要总结
This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic 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 aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment.
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
Investigational drug - Dose 1
Experimental
干预措施: ACT-128800 (Drug)
Investigational drug - Dose 2
Experimental
干预措施: ACT-128800 (Drug)
Matching placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.
时间窗: Baseline to week 16
次要结局
- Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16.(Baseline to week 16)
研究者
研究点 (67)
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