A Multi-center,Randomized,Double-blind,Placebo,Parallel-controlled Phase II Clinical Study of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving at least a 50% Reduction in Eczema Area and Severity Index (EASI 50) from Baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Jaktinib in participants with moderate to severe atopic dermatitis.
详细描述
The study is divided into two stages, the first stage test (1-12 weeks): the main test; the second stage test (13-24 weeks): the extended test.
The main test：The trial set up 4 treatment groups, including 3 dose exploration groups, Jaktinib 50mg Bid, 75mg Bid, 100mg Bid group and 1 placebo control group.
The extended test：Subjects in the placebo group were randomly assigned to receive Jaktinib 50mg Bid, 75mg Bid, and 100mg Bid treatments at a ratio of 1:1:1 (randomized in a blinded state and completed by IWRS in the background), the main test group (50mg Bid, 75mg Bid, 100mg Bid group) subjects still maintain the original dose after 12 weeks.
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
- Double (Participant, Investigator)
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
- •Meet the Chinese diagnostic criteria for atopic dermatitis (Zhang's criteria) and be diagnosed as atopic dermatitis.
- •Participants must have moderate to severe AD at screening and randomization.
- •Participants must have inadequate response to topical medications within 6 months of screening.
- •Agree to use emollients daily
排除标准
- •Received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks prior to randomization.
- •Have received certain types of vaccinations.
- •Participants who do not agree to use adequate contraception during the trial and within 4 weeks after the last dose.
- •Any Participants whom the investigator deems inappropriate for participation in this clinical study
研究组 & 干预措施
Jaktinib 50mg Bid
Jaktinib 50mg Bid+ Placebo 50mg Bid+Placebo 75mg Bid
干预措施: Jaktinib (Drug)
Jaktinib 75mg Bid
Jaktinib 75mg Bid+ Placebo 100mg Bid
干预措施: Jaktinib (Drug)
Jaktinib 100mg Bid
Jaktinib 100mg Bid+ Placebo 75mg Bid
干预措施: Jaktinib (Drug)
placebo
Placebo 100mg Bid+ Placebo 75mg Bid
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving at least a 50% Reduction in Eczema Area and Severity Index (EASI 50) from Baseline
时间窗: At Week 12
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD)
次要结局
- Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement(Treatment at 2,4,8,12,16,20,24 weeks)
- Percentage of Participants Achieving IGA of 0 or 1.(Treatment at 2,4,8,12,16,20,24 weeks)