A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 39
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety
研究概览
简要总结
The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, severe alopecia areata. Patients from European sites who previously completed a qualifying CTP-543 clinical trial may participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial
排除标准
- •Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis
- •Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication
- •Donation of blood at any point throughout the study and for 30 days after last dose of study medication
研究组 & 干预措施
CTP-543
Patients who previously completed a qualifying CTP-543 clinical trial
干预措施: CTP-543 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety
时间窗: 108 weeks
Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108
时间窗: 108 weeks
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). This outcome measures the relative Change from Pre-zero Baseline in Total SALT Scores. Relative change from baseline was defined as 100\*(post-baseline value - baseline)/baseline.
次要结局
未报告次要终点