NCT07106372尚未招募3 期
A Multi-center, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Stapokibatrt in Children With Atopic Dermatitis
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a multi-center, single-arm, open-label phase 3 study to evaluate the safety, efficacy, Pharmacokinetics(PK) and immunogenicity of Stapokibatrt in children with Atopic Dermatitis.
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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the continuing study and sign the written Informed Consent Form(ICF).
- •Subjects who must complete the evaluation of Week 18 of the main study.
- •Have the ability to communicate well with the researcher and comply with the follow-up visits of the protocol.
排除标准
- •Planned major surgical procedure during the patient's participation in this study.
- •Any other circumstances in which the researcher deems not suitable to participate in this study.
研究组 & 干预措施
Stapokibatrt group
Experimental
干预措施: Stapokibatrt (Biological)
结局指标
主要结局
Adverse events
时间窗: up to week 44
Incidence of adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
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