NCT05526222进行中（未招募）3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of Jaktinib Hydrochloride Tablets in the Treatment of Adult Patients With Moderate and Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 443
- 试验地点
- 1
- 主要终点
- The efficacy in the treatment of moderate and severe atopic dermatitis
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled phase III clinical study of jaktinib hydrochloride tablets in the treatment of adult patients with moderate and severe atopic dermatitis
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have fully understood the test and voluntarily signed the informed consent;
- •When signing the informed consent form, the age of male or female subjects must be ≥ 18 years old;
- •The onset time of atopic dermatitis was at least 1 year at the time of screening, and the subjects met the Hanifin and Rajka criteria for atopic dermatitis at the time of screening;
- •For women with reproductive ability and all male subjects, during the trial period and within 6 months after the discontinuation of the trial drug, they must maintain abstinence or contraception, including but not limited to physical and drug contraception.
- •The subjects were able to communicate well and agreed to follow the study and follow-up procedures.
排除标准
- •The investigator considers that any subjects are not suitable to participate in the trial.
研究组 & 干预措施
Jaktinib low dose
Experimental
Low dose
干预措施: Jaktinib Hydrochloride Tablet (Drug)
Jaktinib high dose
Experimental
High dose
干预措施: Jaktinib Hydrochloride Tablet (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Jaktinib Hydrochloride Tablet (Drug)
结局指标
主要结局
The efficacy in the treatment of moderate and severe atopic dermatitis
时间窗: 16 weeks
The proportion of subjects whose Eczema Area and Severity Index (EASI) total score decreased by ≥ 75% from baseline
次要结局
- The abnormal laboratory values and/or adverse events in the treatment of moderate and severe atopic dermatitis(up to 1 year)
研究者
研究点 (1)
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