NCT05671445招募中2 期
An Open, Multineutral Study Evaluating the Safety and Efficacy of CM326 in the Long-term Treatment of Adult Subjects With Atopic Dermatitis
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
This is a open-label, multi-center study to evaluate the safety and efficacy of CM326 in atopic adrmatitis subjects.
详细描述
The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.
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
- •With confirmed Atopic Dermatitis (AD) at the screening.
- •Have the ability to understand the nature of the study and voluntarily sign the informed consent.
- •Be able to communicate well with investigators and follow up protocol requirements.
- •The subjects agreed to use highly effective contraceptive measures during the study.
排除标准
- •Not enough washing-out period for previous therapy.
- •Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.
- •Major surgery is planned during the study period.
- •Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
研究组 & 干预措施
CM326
Experimental
CM326 injection, subcutaneous (SC)
干预措施: CM326 (Biological)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: at week 52
Incidence of treatment-emergent Adverse events related to CM326
次要结局
未报告次要终点
研究者
研究点 (1)
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