A Randomized, Double Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 Tablets in Adult Patients With Alopecia Areata
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 29
- 主要终点
- Percentage change from baseline in Severity of Alopecia Tool (SALT) score
研究概览
简要总结
This is a global Phase 2 study to evaluate the safety and effectiveness of an investigational study drug (called SHR0302) in adults with moderate to severe alopecia areata.
详细描述
The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 3 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between 18-65 years of age (both inclusive), at the time of informed consent;
- •Must have moderate to severe alopecia areata.
排除标准
- •Other types of alopecia or other diseases that can cause hair loss
- •Other scalp diseases that could interfere with assessment of hair loss/regrowth
- •Any previous use of any Janus kinase (JAK) inhibitor
研究组 & 干预措施
SHR0302 Dose#1
干预措施: SHR0302 (Drug)
SHR0302 Dose#2
干预措施: SHR0302 (Drug)
SHR0302 Dose#3
干预措施: SHR0302 (Drug)
Placebo
干预措施: SHR0302 (Drug)
结局指标
主要结局
Percentage change from baseline in Severity of Alopecia Tool (SALT) score
时间窗: week 24
Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss
次要结局
未报告次要终点