An Open-Label (Part A) and a Double-Blind, Randomized, Placebo Controlled (Part B) Study, With an Open-Label Extension, of Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 90
- 主要终点
- Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).
研究概览
简要总结
A phase 2 study to find out if the drug ruxolitinib Phosphate Cream is safe and has beneficial effects in people who have alopecia areata (partial or complete hair loss) when applied to the skin.
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
- 是
入选标准
- •Diagnosis of AA
- •Duration and extent of current episode of AA
- •Evidence of active hair loss
排除标准
- •Evidence of diffuse, spontaneous terminal hair regrowth
- •Receipt of treatment known to potentially affect the course of AA within last month
研究组 & 干预措施
Ruxolitinib Phosphate Cream
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks;
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
干预措施: Ruxolitinib Phosphate Cream (Drug)
Placebo Cream
Part B: Double-blind treatment is 24 weeks (and/or treatment with Ruxolitinib Phosphate Cream if eligible) and follow-up is an additional 12 weeks.
干预措施: Placebo Cream (Drug)
Placebo Cream
Part B: Double-blind treatment is 24 weeks (and/or treatment with Ruxolitinib Phosphate Cream if eligible) and follow-up is an additional 12 weeks.
干预措施: Ruxolitinib Phosphate Cream (Drug)
结局指标
主要结局
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).
时间窗: Up to Week 24
Percentage of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.
Part B : Percentage of Participants Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented)
时间窗: Week 24
Percentage of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.
次要结局
- Part A and B : Number of Treatment-emergent Adverse Events(Up to 100 weeks)
- Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.(Up to Week 24)
- Part B : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).(Week 24)
- Part B: Mean Change From Baseline in SALT Score(Weeks 4, 8, 12, 18, and 24.)
- Part B : Percentage of Participants Achieving a SALT50 in Terminal Hair (Pigmented and Nonpigmented).(Weeks 4, 8, 12, and 18.)
- Part B : Percentage of Subjects Whose AA Lesions Treated Since Baseline Achieved a Physician's Global Assessment of Regrowth (PGARG) Score of at Least 3(Baseline to Week 24)
- Part A and B : Percentage of Participants Achieving a SALT90 Response in Terminal Hair.(Weeks 4, 8, 12, 18, and 24.)