NCT07234591招募中不适用
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis
Usynova Pharmaceuticals Ltd.1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年10月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The Percentage of Participants Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Week 12
研究概览
简要总结
A Study to evaluate efficacy and safety in subjects with moderate to severe Plaque Psoriasis treated with a TYK2 Inhibitor for 12 weeks
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
- •Male and female, ages 18 to 70 years
- •Body weight >40 kg, body mass index (BMI) of 18 to 40 kg/m2
- •Clinical diagnosis of plaque psoriasis for ≥6 months before the Baseline visit
- •Women of childbearing potential (WOCBP) and males who are sexucally active must agree to follow instructions for method(s) of contraception.
排除标准
- •Diagnosed with non-plaque psoriasis
- •Previously received tyrosine kinase 2 (TYK2) inhibitors
- •Previously received other psoriasis treatments such as biological agents, immunoregulators, or hormonal drugs within a specific period before administration, and the investigator deems it may affect the immunity of the subjects
- •Has participated in any clinical trials within 30 days or 5 half-lives of the drug before the first administration, or currently undergoing visits for other clinical trials;
- •Has history of chronic disease that may affect the study, or acute or chronic severe infectious diseases, such as a history of active or inadequately treated latent tuberculosis infection, severe bone or joint infections within 6 months before screening, and other acute infectious diseases.
- •Has known or suspected skin or systemic autoimmune diseases other than psoriasis and psoriatic arthritis;
- •Other conditions that the investigator deems unsuitable for participation in this study.
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
dose level 1
Experimental
干预措施: Tyk2 inhibitor (Drug)
dose level 2
Experimental
干预措施: Tyk2 inhibitor (Drug)
dose level 3
Experimental
干预措施: Tyk2 inhibitor (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The Percentage of Participants Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Week 12
时间窗: Baseline to Week 12
次要结局
- Percentage of Participants With PASI-90, PASI-100 on Week 12(Baseline to Week 12)
- Percentage of Participants on Week 12 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate)(Baseline to Week 12)
- Change From Baseline in DLQI Scores to Week 12(Baseline to Week 12)
- Change From Baseline in BSA to Week 12(Baseline to Week 12)
- Number of Participants With Adverse Events(From enrollment to Day 112)
- Mean steady-state plasma concentration of the drug (Cav,ss)(Day 1, Day 8, Day 15, Day 29, Day 57, Day 84)
- Steady-state trough plasma concentration of the drug (Ctrough, ss)(Day 1, Day 8, Day 15, Day 29, Day 57, Day 84)
- The area under the steady-state blood drug concentration-time curve (AUCss)(Day 1, Day 8, Day 15, Day 29, Day 57, Day 84)
研究者
研究点 (1)
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