A Phase III Extended Clinical Trial of Long-term Safety and Efficacy of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Number and percentage of subjects with Serious Adverse Event (SAE)
研究概览
简要总结
To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis
详细描述
If the enrolled subjects received the treatment of jaktinib hydrochloride tablets in the ZGJAK025 trial, they will continue to use the drug at the original dosage; If the enrolled subjects received placebo treatment in the ZGJAK025 trial, they will receive 100mg BID of jaktinib hydrochloride tablets, 75mg BID of jaktinib hydrochloride tablets or placebo at a ratio of 1:1:1 at random, and continue to take the drug on an empty stomach, with the longest continuous treatment not exceeding 36 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The investigator thinks that the subject can continue to benefit from participating in the extension trial;
- •Fully understand the extension trial and sign the informed consent form;
- •Complete the ZGJAK025 trial for 16 weeks and have good compliance;
- •It is expected that the time interval between the first administration and the last administration of ZGJAK025 trial for the subject should be ≤ 4 weeks;
排除标准
- •Within 4 weeks before enrollment, there were any adverse events ≥ 3 levels related to the test drug that did not return to level 1 or normal;
- •The investigator thinks that the subject is not suitable for the trial.
研究组 & 干预措施
Jaktinib 100mg BID
Drug: Jaktinib Hydrochloride Tablet 100mg dosage, orally administered, twice a day
干预措施: Jaktinib Hydrochloride Tablet (Drug)
Jaktinib 75mg BID
Drug: Jaktinib Hydrochloride Tablet 75mg dosage, orally administered, twice a day
干预措施: Jaktinib Hydrochloride Tablet (Drug)
Placebo
Drug: Placebo Orally administered, twice a day
干预措施: Jaktinib Hydrochloride Tablet (Drug)
结局指标
主要结局
Number and percentage of subjects with Serious Adverse Event (SAE)
时间窗: 36 weeks after the first dose
Safety of the drug
Number and percentage of subjects with treatment emergent adverse event (TEAE)
时间窗: 36 weeks after the first dose
Safety of the drug
次要结局
- The diachronic change in the proportion of subjects whose total Eczema area and severity index （EASI） score decreased by ≥ 75% from baseline(36 weeks after the first dose)
- The diachronic change of the proportion of subjects whose systemic Investigator's Global Assessment （IGA） score reached 0 or 1 and decreased by ≥ 2 points from baseline(36 weeks after the first dose)
- The diachronic change in the proportion of subjects whose pruritus Numerical Rating Scale （NRS） score improved by ≥ 4 points from baseline(36 weeks after the first dose)