NCT06012812已完成2 期
A Multicenter, Open-label, Extended Study Evaluating the Safety and Efficacy of SHR-1819 Injection in Adult Subjects With Moderate to Severe Atopic Dermatitis Who Have Previously Participated in SHR-1819 Studies for the Treatment of Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Treatment Emergent Adverse Events (TEAEs) (per person-year)
研究概览
简要总结
This study is a multicenter, open-label, extended study to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of SHR-1819 injection in adult subjects with moderate to severe atopic dermatitis who have previously participated in the SHR-1819 injection study for atopic dermatitis (defined as the main study, referred to as the main study hereinafter).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 age of 18~75 years old at the time of signing the informed consent form (including the values at both ends), gender is not limited；
- •Previous atopic dermatitis, (1) participation in a complete main study; or (2) subjects who prematurely terminate primary study therapy for reasons other than SHR-1819 injection are required to complete a last safety follow-up or withdrawal from the visit, and the investigator assesses that the influencing factor has been eliminated/no longer affects the participant's participation in the extended study. Participants were required to meet the main study inclusion criteria for the main study；
- •Be able to apply a topical emollient (moisturizer) continuously for at least 7 consecutive days before the first dose and continue to use it for the duration of the study;
- •Be able to sign informed consent forms, understand and agree to follow the requirements of the study and the trial process.
排除标准
- •Pregnant or lactating women；
- •Female subjects of childbearing potential and male subjects whose partners are women of childbearing age have a plan to donate sperm/eggs from the signing of the informed consent form until 3 months after the last dose of the trial drug, or refuse to comply with the relevant contraceptive requirements;
- •A history of alcohol abuse or illicit drug abuse within 6 months prior to screening;
- •Hypersensitivity to the study drug or any ingredient in the study drug；
- •Diagnosed within 6 months prior to screening or judged by the investigator to have a suspected immunosuppressive disease;
- •Oral or parenteral systemic antimicrobials are used within 2 weeks before the first dose；
- •Suspected or confirmed active tuberculosis (TB);
- •Have malignancy or history of malignancy prior to screening；
- •Major surgery was performed within 3 months prior to screening, or major surgery was planned during the study；
- •There are currently significant abnormal laboratory test results, severe concomitant diseases, and other circumstances that the investigator considers inappropriate to participate in this trial;
- •There were treatment-related adverse events leading to discontinuation of treatment and study drug-related SAEs in the main study, and the investigator or sponsor medical department considered that continuing to participate in extended therapy would pose an unacceptable safety risk to participants.
研究组 & 干预措施
SHR-1819 injection
Experimental
干预措施: SHR-1819 injection (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events (TEAEs) (per person-year)
时间窗: Up to 60 weeks
次要结局
- Adverse Events of Special Interest (AESI) during treatment (per person-year)(Up to 60 weeks)
- Proportion of participants with a Global Assessment (IGA) score of 0 or 1 (0-4 scale) per visit(Up to 60 weeks)
- Serious Adverse Event (SAE) during treatment (per person-year)(Up to 60 weeks)
- Time to first remission (remission defined as IGA = 1 or 0 after treatment) in this study (for participants visiting 2 baseline IGAs ≥2)(Up to 60 weeks)
- Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819(From the beginning of administration to the 60th week)
- Proportion of participants with at least 1 remission in this study(Up to 60 weeks)
- Time to first relapse in this study (relapse defined as IGA = 3 or 4 points after remission) (for participants with Visit 2 baseline IGA ≥ 2)(Up to 60 weeks)
- The concentration of SHR-1819 in serum :Cmax(From the beginning of administration to the 60h week)
研究者
研究点 (1)
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