NCT05715320已完成2 期
A Randomized, Double Blind, Parallel-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection 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 160 人开始时间: 2023年3月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving EASI-75
研究概览
简要总结
This study is a multi-center, randomized, double-blind, parallel controlled phase 2 study, aimed at evaluating the efficacy and safety of CM310 in the treatment of patients with moderate-to-severe atopic dermatitis, and observing Pharmacokinetics characteristics, Pharmacodynamics effects and immunogenicity.
详细描述
This study includes screening, treatment and follow-up periods. 160 subjects will be enrolled to receive CM310.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 ICF.
- •Age ≥ 18 and ≤ 75 years old, male or female.
- •The fertile subjects agreed to take effective contraceptive measures throughout the study period.
- •The subjects can communicate well with the investigators and complete the follow-up according to the protocol.
排除标准
- •Live vaccine or attenuated live vaccine has been vaccinated or planned to be vaccinated within 12 weeks before randomization.
- •He received allergen-specific immunotherapy (desensitization therapy) within 6 months before randomization.
- •Major surgery is planned during the study period.
- •Previous history of atopic keratoconjunctivitis and corneal involvement.
- •Other combined skin diseases that may affect the evaluation of the study.
- •Confronting IL-4R α Monoclonal antibody or CM310/placebo drug or ingredient allergy.
研究组 & 干预措施
Group A
Experimental
CM310, subcutaneous
干预措施: CM310 (Biological)
Group B
Experimental
CM310, subcutaneous
干预措施: CM310 (Biological)
结局指标
主要结局
Proportion of subjects achieving EASI-75
时间窗: up to week 12
Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score).
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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