NCT07544862招募中不适用
A Prospective Study of Stapokibart Injection in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
Chengdu Kangnuoxing Biopharma,Inc.1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年6月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The incidence rate of adverse reactions
研究概览
简要总结
This study is an open label, prospective study to evaluate the safety and efficacy of Stapokibart Injection in patients with AD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trial participants aged 18 years or older at baseline, with no restrictions on gender.
- •Physician decision to treat trial participants with Stapokibart Injection for AD (according to the China-specific prescribing information) made prior to and independently of the participant's participation in the study.
排除标准
- •Known history of allergic reaction to Stapokibart Injection.
- •Trial participants currently or plan participating in any interventional clinical trial.
- •Trial participants with hematologic malignancies.
- •Women with pregnant.
- •Any condition that, in the opinion of the investigator, may interfere with trial participants' ability to participate in the study.
研究组 & 干预措施
Group of Stapokibart Injection
干预措施: Stapokibart (Biological)
结局指标
主要结局
The incidence rate of adverse reactions
时间窗: From enrollment to the end of treatment at 52 weeks.
Number of Adverse Reactions is calculated based on Adverse Events and Serious Adverse Events that were assessed by the investigator as related to the study drug and categorized according to the Medical Dictionary for Regulatory Activities.
次要结局
未报告次要终点
研究者
研究点 (1)
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