NCT03988335已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 17
- 主要终点
- Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
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)
盲法说明
Double-blind
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
- •At least a 6-month history of PPP as defined by the presence of pustules on palms and/or soles, but without evidence of infection on palms and soles
- •Moderate or severe PPP, as defined by Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) ≥8 and Palmoplantar Pustulosis Physician Global Assessment (PPPGA) ≥3 at Day -1, and a minimum of 8 fresh pustules at screening (fresh pustule count on both right/left palms and soles) and 20 fresh pustules at Day -1 (fresh pustule count on both right/left palms and soles)
- •Males and females must be willing to use birth control as indicated
排除标准
- •Moderate to severe psoriasis, as defined by plaque psoriasis covering ≥10% of total Body Surface Area (BSA) at Day -1
- •Subject is known to have an immune deficiency or is immunocompromised
- •Positive test for hepatitis, human immunodeficiency virus (HIV) or tuberculosis
- •Use of topical therapies for PPP within 2 weeks of Day -1 and/or systemic therapies for PPP within 4 weeks
研究组 & 干预措施
RIST4721
Experimental
RIST4721 as once-daily 300mg oral solution for 28 days.
干预措施: RIST4721 (Drug)
Placebo
Placebo Comparator
Placebo as once-daily 300mg oral solution for 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline
时间窗: Baseline to Day 28
Relative change from baseline in fresh pustule count at Day 28
Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline
时间窗: Baseline to Day 28
Relative change from baseline in total pustule count at Day 28
次要结局
未报告次要终点
研究者
研究点 (17)
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