NCT07386743尚未招募3 期
A Multicenter, Randomized, Double-blinded, Parallel, Positive-controlled, Phase III Comparative Study to Evaluate GS101 Injection Versus Dupixent® in Participants With Moderate-to-Severe Atopic Dermatitis
Jiangsu Genscend Biopharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 572 人开始时间: 2026年2月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 572
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving EASI-75 at week 16
研究概览
简要总结
This is a a multicenter, randomized, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis. A total of 572 subjects are planned to be included and randomized at a ratio of 1:1 to receive GS101 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, male or female, between the ages of 18 and 75 years (inclusive)
- •At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history for at least 1 year prior to screening
- •During the screening period and at baseline, patients with moderate-to-severe atopic dermatitis, defined as meeting all of the following 3 criteria concurrently: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA ≥ 10%.
排除标准
- •Hypersensitivity or known allergy to the investigational product(s) or any of their excipients
- •Treatment with any investigational drug, medical device, or other biologic agent within 8 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer
- •Receipt of any live or live-attenuated vaccine within 3 months prior to randomization, or planned receipt of such vaccines during the study period
研究组 & 干预措施
GS101 injection
Experimental
干预措施: GS101 injection (Drug)
Dupixent®
Active Comparator
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(Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52)
- Proportion of patients achieving EASI-50(Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52)
- Proportion of patients achieving EASI-90(Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52)
研究者
研究点 (1)
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