NCT07211542招募中2 期
A Randomized, Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of SHR-1905 Injection in Patients With Moderate to Severe Atopic Dermatitis
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年11月7日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The proportion of subjects whose Eczema Area and Severity Index (EASI) score decreased ≥ 75% compared to the baseline.
研究概览
简要总结
This trial was designed to evaluate the efficacy and safety of SHR-1905 in patients with moderate-to-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
- 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
- •The subjects have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the researcher, understand and are willing to strictly abide by the requirements of this clinical research protocol to complete the study.
- •At the time of signing the informed consent, the subjects are ≥ 18 years old and ≤ 75 years old, male or female.
- •Have atopic dermatitis at screening.
排除标准
- •Hypersensitivity to the study drug or any ingredient in the study drug.
- •Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
- •Has malignancy or has a history of malignancy.
- •Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.
- •Females who are pregnant or lactating.
研究组 & 干预措施
SHR-1905 Injection Group - Dose 1
Experimental
Dose 1.
干预措施: SHR-1905 Injection (Drug)
SHR-1905 Injection Placebo Group
Placebo Comparator
干预措施: SHR-1905 Injection Blank Preparation (Drug)
SHR-1905 Injection Group - Dose 2
Experimental
Dose 2.
干预措施: SHR-1905 Injection (Drug)
结局指标
主要结局
The proportion of subjects whose Eczema Area and Severity Index (EASI) score decreased ≥ 75% compared to the baseline.
时间窗: Week 16.
Eczema Area and Severity Index (EASI) score using the Eczema Area and Severity Index scale.
The percentage change in Eczema Area and Severity Index (EASI) score from the baseline.
时间窗: Week 16.
Eczema Area and Severity Index (EASI) score using the Eczema Area and Severity Index scale.
次要结局
- The proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 (on a 0-4 scale) and a decrease of ≥2 points from the baseline.(At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.)
- The proportion of subjects whose Investigator's Global Assessment (IGA) score decreased ≥ 2 points compared to the baseline.(At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.)
- The change value of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline.(At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.)
- The percentage of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline.(At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.)
- The percentage of change in EASI score from the baseline.(At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.)
- The proportion of subjects whose EASI score decreased ≥ 75% compared to the baseline.(At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.)
- The proportion of subjects whose EASI score decreased ≥ 90% compared to the baseline.(At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.)
- The proportion of subjects whose EASI score decreased ≥ 50% compared to the baseline.(At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.)
- The change value in EASI score from the baseline.(At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.)
- The change in Body Surface Area Involvement of Atopic Dermatitis (BSA) from the baseline.(At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.)
- The percentage of change in Body Surface Area Involvement of Atopic Dermatitis (BSA) from the baseline.(At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.)
- Adverse events (AEs).(At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.)
研究者
研究点 (1)
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