A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 50
- 主要终点
- Proportion of Subjects Achieving a 50% Reduction in PPPASI Score
研究概览
简要总结
A 12-week Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis followed by an Open-label Extension Phase.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 months history of moderate or severe PPP, as defined by PPPASI ≥12 and PPPGA ≥3 at screening
- •Males and females must be willing to use birth control as indicated
排除标准
- •Moderate to severe psoriasis covering ≥10% of total body surface area (BSA) at screening
- •Breastfeeding or pregnant
- •Known immunodeficiency or subject is immunocompromised
- •Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB
- •Any topical medications for PPP excluding emollients within two weeks of randomization and systemic therapies (including phototherapy) within 4 weeks of randomization
研究组 & 干预措施
RIST4721 400 mg
RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
干预措施: RIST4721 (Drug)
RIST4721 200 mg
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
干预措施: RIST4721 (Drug)
RIST4721 200 mg
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
干预措施: Placebo (Drug)
Placebo
Placebo: 4 placebo tablets once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Subjects Achieving a 50% Reduction in PPPASI Score
时间窗: Baseline to Week 12
In the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI), the left palm, right palm, left foot, and right foot are assessed based on 3 target symptoms: erythema, desquamation (scaling), and pustules, as seen on the day of the examination. The severity of each sign is assessed using a 5-point scale (0 = not present, 1 = slight, 3 = moderate, 4 = severe, 5 = very severe). The affected area within a given anatomic site (left palm, right palm, left foot, and right foot) is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of PPP involvement (0 = no involvement, 2 = 10 to less than 30% involvement, 3 = 30 to less than 50% involvement, 4 = 50 to less than 70% involvement, 5 = 70 to less than 90% involvement, 6 = 90 to less than 100% involvement). PPPASI score for palms and soles is obtained using a formula and can vary from 0 (absence of disease) to 72 (most severe disease).
次要结局
- Absolute Change From Baseline in PPPGA(Baseline to Week 12)
- Absolute Change From Baseline in PPPASI(Baseline to Week 12)