NCT07251998招募中2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-332 in Patients With Moderate to Severe Plaque Psoriasis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) at Week 12
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of ICP-332 to placebo in participants with moderate-to-severe 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
- Double (Participant, Investigator)
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
- •Subjects voluntarily participate in this study and have signed the Informed Consent Form (ICF).
- •Male or female subjects aged ≥ 18 years and ≤ 70 years
- •A history of plaque psoriasis for ≥6 months at baseline
- •Meet the following three criteria:
- •Psoriasis Area and Severity Index (PASI) score ≥12
- •Static Physician's Global Assessment (sPGA) score ≥3
- •Psoriasis affected Body Surface Area (BSA) ≥10%
- •The subject requires systemic treatment and/or phototherapy.
排除标准
- •Diagnosed with non-plaque psoriasis.
- •Subject had laboratory values meeting any of the protocol-specified criteria at Screening.
- •Presence of clinically serious, progressive, or uncontrolled disease.
- •Previous history of alcoholism or drug abuse (except for those who have been completely abstinent for more than 6 months before randomization).
- •Pregnant or lactating women.
- •The investigator accepts ICP-332 for any reason that the subject is not suitable for this study.
研究组 & 干预措施
ICP-332 Dose A
Experimental
干预措施: ICP-332 Tablets (Drug)
ICP-332 Dose B
Experimental
干预措施: ICP-332 Tablets (Drug)
ICP-332 Dose C
Experimental
干预措施: ICP-332 Tablets (Drug)
ICP-332 Placebo
Placebo Comparator
干预措施: ICP-332 Placebo Tablets (Other)
结局指标
主要结局
The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) at Week 12
时间窗: Day 1 to Day 85
次要结局
未报告次要终点
研究者
研究点 (1)
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