NCT06884891尚未招募3 期
A Multicenter Randomized, Double-blinded, Parallel, Positive-controlled, Phase Ⅲ Comparative Study to Evaluate the Efficacy and Safety of QL2108 to Dupixent® in Adult Subjects With Moderate-to-Severe Atopic Dermatitis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 520
- 主要终点
- Proportion of patients achieving EASI-75 at week 16.
研究概览
简要总结
It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase Ⅲ comparative study to evaluate the efficacy and safety of QL2108 to Dupixent® in adult subjects with moderate-to-severe atopic dermatitis. A total of 520 subjects are planned to be included and randomized at a ratio of 1:1 to receive QL2108 injection or Dupixent®
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged from 18 to 75 years (including the boundary value)
- •At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history of ≥1 year prior to screening.
- •During the screening period and prior to randomization: EASI score ≥16, IGA score ≥3, BSA ≥10%.
排除标准
- •People who have previously used or participated in clinical trials of monoclonal antibody with the same target or dupilumab
- •Having participated in drug or device clinical trials within 12 weeks or 5 half-lives of other investigational drugs before the study administration.
- •Subjects who have received live vaccines or live-attenuated vaccines within 12 weeks prior to randomization or plan to receive such vaccines during the trial period.
研究组 & 干预措施
QL2108 injection
Experimental
QL2108 injection; 300mg/2.0mL; subcutaneous injection
干预措施: QL2108 injection (Drug)
Dupixent®
Active Comparator
Dupixent®; 300mg/2.0mL; subcutaneous injection
干预措施: Dupixent® (Drug)
结局指标
主要结局
Proportion of patients achieving EASI-75 at week 16.
时间窗: 16 weeks
EASI-75
次要结局
- Proportion of patients achieving EASI-75 at week 52(52 weeks)
- Proportion of patients achieving IGA-TS (IGA score was 0 or 1 and decreased by ≥2 points from baseline) at week 16 and week 52(16 weeks and 52 weeks)
研究者
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