A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM326 Injection in the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 16
研究概览
简要总结
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis 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
- 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
- •With confirmed Atopic Dermatitis (AD) at the screening.
- •Age ≥ 18 years and ≤ 75 years, male or female.
- •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.
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.
结局指标
主要结局
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 16
时间窗: at week 16
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and reduction from baseline of ≥2 points at Visit 16
时间窗: at week 16
IGA is a 5-point scale ranging from 0 (clear) to 4 (very severe)
次要结局
未报告次要终点