A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of LW402 in Patients With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving EASI-50 at week 12
研究概览
简要总结
This is a multi-center, randomized, double blind, placebo-controlled phase 2 study to evaluate the efficacy, safety, PK and PD ofLW402 in patients with moderate-to-severe atopic dermatitis.
详细描述
The study consists of an up-to-4-week screening period, a 12-week double-blind treatment period and a 4-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
排除标准
- •Not enough washing-out period for previous therapy. Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- •pregnancy. Other.
研究组 & 干预措施
LW402 Low Dose
LW402 administered orally, BID (low dose)
干预措施: LW402 (Drug)
LW402 Medium Dose
LW402 administered orally, BID (medium dose)
干预措施: LW402 (Drug)
LW402 High Dose
LW402 administered orally, BID (high dose)
干预措施: LW402 (Drug)
Placebo
LW402 placebo administered orally, BID
干预措施: LW402 placebo (Drug)
结局指标
主要结局
Proportion of participants achieving EASI-50 at week 12
时间窗: 12 weeks
Proportion of participants achieving EASI-50 (≥50% reduction from baseline in Eczema Area and Severity Index score) at week 12. 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).
次要结局
- PD: pSTAT3 and pSTAT5 inhibition rates(12 weeks)
- Proportion of participants achieving EASI-75 at week 12(12 weeks)
- Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.(16 weeks)
- Proportion of participants with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 12(12 weeks)