A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Patients With Moderate-to-severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving EASI-75 at week 16
研究概览
简要总结
This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in patients with moderate-to-severe atopic dermatitis.
详细描述
The study consists of an up-to-4-week screening period, a 16-week double-blind treatment period, a 36-week maintenance 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
- •Diagnosed with AD for at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
排除标准
- •Not enough washing-out period for previous therapy.
- •Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- •Organ dysfunction.
- •pregnancy.
研究组 & 干预措施
CM310
CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W)
干预措施: CM310 (Drug)
Placebo
Double blind treatment period : Placebo
Maintenance treatment period : CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W)
干预措施: CM310 (Drug)
Placebo
Double blind treatment period : Placebo
Maintenance treatment period : CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W)
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of subjects achieving EASI-75 at week 16
时间窗: 16 weeks
Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score) at week 16. The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16
时间窗: 16 weeks
Proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16. IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
次要结局
- Percent change of NRS score from baseline(52 weeks)
- Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.(64 weeks)
- Percent change of EASI score from baseline(52 weeks)
- Body surface area (BSA) of involvement of atopic dermatitis(52 weeks)
- Changes from baseline in Dermatology Life Quality Index (DLQI)(52 weeks)
- Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)(64 weeks)