NCT06116565已完成2 期
An Multi-center, Open-label, Single-arm Phase 2 Study to Evaluate the Long-term Safety and Efficacy of CM310 in Subjects With Moderate-to-severe Atopic Dermatitis
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2023年12月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This is a multi-center, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.
详细描述
The study consists of an screening period, treatment period, and 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
- •Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- •Age ≥ 18 and ≤ 75 years old.
- •With Atopic Dermatitis.
排除标准
- •Not enough washing-out period for previous therapy.
- •Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- •Major surgeries are planned during the study period.
研究组 & 干预措施
CM310
Experimental
干预措施: CM310 (Biological)
结局指标
主要结局
Adverse events (AEs)
时间窗: up to Week 60
Incidence of adverse events (AEs).
次要结局
- Percentage of subjects achieving ≥90% improvement from baseline in the Eczema Area and Severity Index (EASI-90) at each scheduled assessment visit(up to Week 60)
- Change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit(up to Week 60)
- Incidence of treatment-emergent anti-drug antibodies (ADA)(up to Week 60)
- Percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit(up to Week 60)
- Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 0 at each scheduled assessment visit(up to Week 60)
- Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 1 at each scheduled assessment visit(up to Week 60)
- Percentage of subjects achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) at each scheduled assessment visit(up to Week 60)
- Change and percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit(up to Week 60)
- Percentage of subjects achieving a ≥4-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores(up to Week 60)
- Percentage of subjects achieving a ≥3-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores(up to Week 60)
- Change and percentage change from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores(up to Week 60)
- Change and percentage change from baseline in the body surface area (BSA) affected by atopic dermatitis (AD) at each scheduled assessment visit(up to Week 60)
- Change from baseline in Dermatology Life Quality Index (DLQI) score at each scheduled assessment visit(up to Week 60)
- Trough concentration (Ctrough) of CM310(up to Week 60)
- Incidence of neutralizing antibodies (NAb)(up to Week 60)
研究者
研究点 (1)
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