A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Jaktinib in Adult Patients With Severe Alopecia Areata
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 2
- 主要终点
- Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at Week 24
研究概览
简要总结
This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called Jaktinib) in adults (≥18 years and <65 years) who have 50% or greater scalp hair loss. 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). It is 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
- •participants voluntarily sign the informed consent form (ICF);
- •Age ≥ 18 years and <65 years, either male or female;
- •Clinical presentation compatible with alopecia areata with a current episode lasting not exceeding ≤8 years.
- •At least 50% scalp hair loss.
- •Willing to comply with the study visits and requirements of the study protocol.
排除标准
- •participants has taken a JAK inhibitor prior to randomization;
- •participants who are unsuitable to the trial, as identified by the investigator.
研究组 & 干预措施
Jaktinib 50mg BID
Participants received Jaktinib 50mg tablets, orally, twice daily (BID) for up to 24 weeks.
干预措施: Jaktinib (Drug)
Jaktinib 75mg BID
Participants received Jaktinib 75mg tablets, orally, twice daily (BID) for up to 24 weeks.
干预措施: Jaktinib (Drug)
placebo
Participants received Jaktinib matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at Week 24
时间窗: Week 24
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
次要结局
- Percentage of Participants Achieving 50% Improvement of SALT (SALT50)(Week 24)