NCT07047612招募中2 期
A Phase II/III Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive Design, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Subjects With Non-segmental Vitiligo
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 603
- 试验地点
- 45
- 主要终点
- Phase2: Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24.
研究概览
简要总结
This a phase II/III randomized, double-blind, placebo-controlled, parallel group, adaptive design, multi-center study to evaluate the efficacy and safety of ICP-332 in subjects with non-segmental vitiligo。The study consisted an phase 2 part and an phase 3 part.
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥18 years and ≤75 years (Phase II portion). Male or female subjects ≥12 years of age and ≤75 years of age, adolescent subjects must weigh ≥40 kg (Phase III portion).
- •Eligible subjects must meet all of the following criteria at screening and baseline:
- •The clinical diagnosis was non-segmental vitiligo for at least 3 months.
- •Involvement of BSA≥5%.
- •Facial involvement BSA≥0.5%.
- •F-VASI≥0.5 and T-VASI between 5 and
- •Active or stable non-segmental vitiligo was present at both screening and baseline visits.
- •Women of childbearing potential (WOCBP) and Men must agree to contraception.
- •Before beginning any screening or study specific procedures, subjects must voluntarily sign informed consent.
排除标准
- •Any of the following vitiligo related medical conditions and other skin diseases/conditions.
- •a) Subjects had other types of vitiligo (including but not limited to segmental vitiligo and mixed vitiligo) that did not meet the criteria for active or stable vitiligo described in Inclusion criteria
- •History of any clinically major diseases, with the exception of vitiligo.
- •Pregnant or breastfeeding females.
- •The investigator considers that the subject is not suitable for participation in this study for any reason.
研究组 & 干预措施
ICP-332 dose A（Phase2）
Experimental
干预措施: ICP-332 Tablets (Drug)
Placebo（Phase2）
Placebo Comparator
干预措施: ICP-332 Placebo Tablets (Drug)
ICP-332 dose B（Phase2:）
Experimental
干预措施: ICP-332 Tablets (Drug)
ICP-332 dose A or dose B（Phase3）
Experimental
干预措施: ICP-332 Tablets (Drug)
Placebo（Phase3）
Placebo Comparator
干预措施: ICP-332 Placebo Tablets (Drug)
结局指标
主要结局
Phase2: Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24.
时间窗: 24 weeks
Phase3: Proportion of subjects achieving F-VASI 75 at Week 52.
时间窗: 52 weeks
次要结局
未报告次要终点
研究者
研究点 (45)
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