NCT03898479进行中（未招募）2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 89
- 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, moderate to severe alopecia areata.
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
Experimental
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: 332 weeks
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)
时间窗: 332 weeks
次要结局
未报告次要终点
研究者
研究点 (89)
Loading locations...
相似试验
已完成
3 期
European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia AreataAlopecia AreataNCT05041803Sun Pharmaceutical Industries, Inc.407
终止
3 期
Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019Relapsing-Remitting Multiple SclerosisMultiple SclerosisNCT01797965Biogen1,501
已完成
3 期
Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00389415Novartis150
已完成
3 期
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular DegenerationNeovascular Age-related Macular DegenerationNCT04777201Hoffmann-La Roche1,036
已完成
3 期
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular EdemaDiabetic Macular EdemaNCT04432831Hoffmann-La Roche1,479