A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of WIN378 in Participants With Moderate - Severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 21
研究概览
简要总结
This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate - severe chronic obstructive pulmonary disease (COPD). WIN378 blocks the action of a protein called TSLP that causes inflammation in the lung and may contribute to COPD control and symptoms. The study will test how doses of WIN378 are handled by the body (pharmacokinetics) and assess the safety of the medicine and markers of COPD inflammation in exhaled breath and blood, lung function and COPD control (pharmacodynamics)
详细描述
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, and pharmacokinetics of WIN378 in adult participants with moderate - severe chronic obstructive pulmonary disease (COPD). Participants will continue their standard background COPD therapy. Eligible participants will receive doses of WIN378 or placebo over a 24-week treatment 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
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40 to 80 years
- •Post-BD spirometry at screening FEV1/FVC < 0.70 and FEV1 30-80% predicted
- •On stable triple inhaled therapy (ICS/LABA/LAMA) for ≥ 3 months
- •Former smoker (≥ 10 pack-year history) and abstinence from smoking for ≥ 6 months
- •Elevated eosinophil count
- •Weight/BMI within allowed range
排除标准
- •Clinically significant pulmonary disease other than chronic obstructive pulmonary disease (COPD)
- •Clinically significant comorbid medical conditions or infections that, in the investigator's judgment, could affect participant safety or interfere with study conduct
- •Clinically significant cardiovascular disease
- •Recent respiratory infection or COPD exacerbation
- •Exposure to approved or experimental biologic therapies for COPD with less than 5 half-life washout period
- •Pregnancy or breastfeeding
- •Smoking or diagnosed substance use disorder
- •Any condition or circumstance that, in the investigator's opinion, would make participation unsafe or compromise study integrity
研究组 & 干预措施
WIN378 Dose 2
WIN378 SC injections will be administered
干预措施: WIN378 (Drug)
Placebo
Placebo SC injections will be administered
干预措施: Placebo (Drug)
WIN378 Dose 1
WIN378 SC injections will be administered
干预措施: WIN378 (Drug)