NCT04487860已完成2 期
A Phase II, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo
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
- 327
- 试验地点
- 31
- 主要终点
- Mean Change From Baseline in Vitiligo Area Scoring Index Score
研究概览
简要总结
This is a randomized, double blind, placebo-controlled, phase II study. The study will be performed as a multicenter, multinational study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent.
- •Male or female ≥ 18 years of age at time of screening
- •Stable (without new patches ≥ 1 year) or unstable (with new patches for the last 1 year) vitiligo
- •VASI of ≥ 4 at screening and baseline
排除标准
- •Segmental vitiligo, focal, or mixed Vitiligo
- •Subjects who have high risk of suicidality at the Screening assessment based on Investigator's judgment
- •History of alcohol or drug abuse in the previous 2 years
- •Subjects who were submitted to melanocyte transfer
研究组 & 干预措施
AS012 dose regimen I
Experimental
Oral
干预措施: AS012 (Drug)
AS012 dose regimen II
Experimental
Oral
干预措施: AS012 (Drug)
AS012 dose regimen III
Experimental
Oral
干预措施: AS012 (Drug)
AS012 dose regimen IV
Experimental
Oral
干预措施: AS012 (Drug)
Placebo
Placebo Comparator
Oral
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Vitiligo Area Scoring Index Score
时间窗: Week 24
Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state
次要结局
- Mean Change From Baseline in Vitiligo Extent Score (VES) on Clinical Pictures(Week 24)
- Mean Change in Vitiligo Impact Patient Scale(Week 24)
- Physician's Global Assessment Scores(Week 52)
- Mean Change From Baseline in Dermatology Life Quality Index(Week 52)
研究者
研究点 (31)
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