NCT07321951进行中（未招募）2 期
A Multicenter, Randomized, Double-blind, Phase II Study to Evaluate the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis
Guangdong Hengrui Pharmaceutical Co., Ltd2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2026年1月9日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- The proportion of participants who achieved EASI-75 (≥75% decrease in the score on the Eczema Area and Severity Index (EASI) from the baseline).
研究概览
简要总结
This trial was designed to evaluate the efficacy and safety of SHR-1819 in adult 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
- •At the time of signing the informed consent, the subjects are ≥18 years old and ≤75 years old, male or female.
- •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.
- •Topical emollients are applied at a stable dose twice daily for at least 7 days before the first dose in the run-in phase and continued for the duration of the study.
- •Have atopic dermatitis at the time of screening and have an investigator-assessed history of atopic dermatitis for at least 1 year before screening.
- •Have moderate to severe atopic dermatitis during the screening period and on the day of the first dose.
排除标准
- •Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
- •A history of spring keratoconjunctivitis and/or atopic keratoconjunctivitis within 6 months prior to screening.
- •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.
- •Hypersensitivity to the study drug or any ingredient in the study drug.
- •Females who are pregnant or lactating.
研究组 & 干预措施
SHR-1819 Injection Group with Dose 1
Experimental
干预措施: SHR-1819 Injection (Drug)
SHR-1819 Injection Group with Dose 1
Experimental
干预措施: SHR-1819 Injection Blank Preparation (Drug)
SHR-1819 Injection Group with Dose 2
Experimental
干预措施: SHR-1819 Injection (Drug)
SHR-1819 Injection Group with Dose 2
Experimental
干预措施: SHR-1819 Injection Blank Preparation (Drug)
SHR-1819 Injection Group with Dose 3
Experimental
干预措施: SHR-1819 Injection (Drug)
SHR-1819 Injection Group with Dose 3
Experimental
干预措施: SHR-1819 Injection Blank Preparation (Drug)
结局指标
主要结局
The proportion of participants who achieved EASI-75 (≥75% decrease in the score on the Eczema Area and Severity Index (EASI) from the baseline).
时间窗: Week 24.
Eczema Area and Severity Index score using the Eczema Area and Severity Index scale.
次要结局
- Adverse events (AEs).(About 42 weeks.)
- The proportion of participants with a baseline daily Itch Numeric Rating Scale (I-NRS) score of ≤4 per week.(Week 24.)
- The concentration of SHR-1819 in serum.(From week -16 to week -8, about every 4 weeks; From week 0 to week 32, about every 8 weeks.)
研究者
研究点 (2)
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