NCT06109818已完成2 期
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis
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
- 129
- 试验地点
- 31
- 主要终点
- Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 12.
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate ICP-488.Efficacy, safety, PK, and PD characteristics in Chinese adults 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 informed consent.
- •Male or female subjects between the ages of 18 and 70 (including the threshold) at the time of signing the ICF.
- •History of plaque psoriasis ≥6 months at baseline.
- •Subjects need to receive systemic therapy and/or phototherapy.
- •The following three criteria were met: a) psoriasis Area and Severity index (PASI) score ≥12; b) Psoriasis affected body surface area (BSA) ≥10%; c) Static physician overall assessment (sPGA) ≥3 scores
排除标准
- •The diagnosis was non-plaque psoriasis.
- •Presence of infection or immune-related disease.
- •Subjects with a history of TB or at risk for TB.
- •Received related treatment within the time window specified in the protocol.
- •An interval of less than 5 half-lives or 28 days (if any available halflife data) from the last dose of a strong CYP1A2 inhibitor or inducer, or a plan to use concurrently medications, dietary supplements or food with strong CYP1A2 inhibitory or inductive effect during study participation.
- •The investigator has determined that there are clinically significant test results and that participation in this trial would pose an unacceptable risk to patients; Or the laboratory values of the subjects in the screening period meet the criteria specified in the protocol.
- •Pregnant or lactating women, or women who plan to become pregnant during study participation.
- •A history of severe drug allergies.
- •Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: ICP-488 Placebo (Drug)
ICP-488 low dose
Experimental
干预措施: ICP-488 Tablets (Drug)
ICP-488 low dose
Experimental
干预措施: ICP-488 Placebo (Drug)
ICP-488 high dose
Experimental
干预措施: ICP-488 Tablets (Drug)
结局指标
主要结局
Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 12.
时间窗: Baseline up to Week 12
Proportion of subjects who achieved PASI 75 (PASI score improvement of at least 75% from baseline) at week 12.
次要结局
未报告次要终点
研究者
研究点 (31)
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