A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 13
- 主要终点
- Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24
研究概览
简要总结
The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blind
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ruxolitinib cream
Ruxolitinib cream will be administered twice a day (BID) for 24 weeks
干预措施: Ruxolitinib cream (Drug)
Vehicle Cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
干预措施: Vehicle Cream (Drug)
结局指标
主要结局
Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24
时间窗: Baseline; Week 4, Week 12, and Week 24
Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. Percentage change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] / Baseline value)\*100.
次要结局
- Number of Participants With a Grade 3 or Higher TEAE During the Double-Blind Period(from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days))
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period(from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days))
- Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts(Baseline, Week 12, and Week 24)
- Number of Participants With TEAEs During the Treatment-Extension Period(from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days)
- Number of Participants With a Grade 3 or Higher TEAE During the Treatment-Extension Period(from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days)