NCT00205465已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of VX-765 in Subjects With Chronic Plaque Psoriasis Requiring Systemic Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Incidence of adverse events
研究概览
简要总结
To evaluate the safety and tolerability of VX-765 in subjects with chronic plaque psoriasis treated for 28 days.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with chronic plaque psoriasis for at least 6 months
- •Prior systemic therapy
排除标准
- •Current or prior history of illness precluding use of immunomodulatory therapy.
结局指标
主要结局
Incidence of adverse events
Abnormal laboratory values
Abnormal ECGs and vital signs
次要结局
- PK/PD
- Target lesion score after 28 days of treatment
- Proportion of subjects meeting "clear" or "almost clear" criteria utilizing a static Physician's Global Assessment (sPGA)
- Proportion of subjects demonstrating ≥ 50% and ≥ 75% decrease from baseline in Psoriasis Area and Severity Index (PASI) to the end of 28 days of treatment
- Change in PASI from baseline to the end of 28 days of treatment
研究者
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