NCT00399906已完成2 期
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety, and Pharmacokinetics of Three Different Doses of BMS-582949 Given Orally to Subjects With Moderate to Severe Plaque Psoriasis
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2007年8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
- 99
- 试验地点
- 1
- 主要终点
- The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12
研究概览
简要总结
The purpose of this clinical research study is to learn if BMS-582949 alone is an effective treatment for moderate to severe psoriasis. The safety of the drug and the effectiveness of each dose will also be studied.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females (not nursing or not pregnant)
- •18-75 years of age
- •Diagnosis of moderate to severe psoriasis for at least six months at the time of screening
- •Subjects will require wash-out of certain therapies for the treatment of psoriasis but will be allowed to continue on certain topical therapies
排除标准
- 未提供
研究组 & 干预措施
P1
Placebo Comparator
10 or 100 mg
干预措施: Placebo (Drug)
A1
Active Comparator
10 mg
干预措施: BMS-582949 (Drug)
A2
Active Comparator
30 mg
干预措施: BMS-582949 (Drug)
A3
Active Comparator
100 mg
干预措施: BMS-582949 (Drug)
结局指标
主要结局
The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12
时间窗: at Week 12
次要结局
- Proportion of subjects achieving a PASI-90(at Week 12)
- Proportion of subjects achieving a PASI-75(at Week 12)
- Proportion of subjects achieving a PASI-50(at Week 12)
研究者
研究点 (1)
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