NCT07459556尚未招募不适用
A Prospective Study of Stapokibart Injection in Patients With SAR
Chengdu Kangnuoxing Biopharma,Inc.1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年3月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The incidence rate of adverse reactions (ADR).
研究概览
简要总结
This study is an open label, prospective study to evaluate the safety of Stapokibart Injection in subjects with SAR.
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
- •Participants aged 18 years or older at the time of informed consent and provide voluntary informed consent to participate in the study before inclusion in the study.
- •Physician decision to treat the participant with Stapokibart Injection for SAR (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.
- •Participants currently or plan participating in any interventional clinical trial.
- •Participants with hematologic malignancies.
- •Women with pregnant.
- •Any condition that, in the opinion of the Investigator, may interfere with the participant's 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 (ADR).
时间窗: From enrollment to the end of treatment at 10 weeks
Number of of Adverse Reactions （ADRs） is calculated based on Adverse Events （AEs） and Serious Adverse Events （SAEs） that were assessed by the investigator as related to the study drug and categorized according to the Medical Dictionary for Regulatory Activities （MedDRA）.
次要结局
未报告次要终点
研究者
研究点 (1)
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