NCT07330310尚未招募3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous JKN2401 Injection in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Joincare Pharmaceutical Group Industry Co., Ltd0 个研究点目标入组 888 人开始时间: 2026年3月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 888
- 主要终点
- Annualised rate of moderate or severe COPD exacerbations
研究概览
简要总结
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous JKN2401 Injection in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent; able and willing to comply with study procedures.
- •Adults with documented COPD diagnosis and medical history consistent with guideline criteria.
- •Relevant exposure history consistent with COPD (e.g., smoking and/or biomass exposure).
- •On stable, guideline-based maintenance COPD therapy prior to randomization, per investigator judgment.
- •Protocol-defined exacerbation history, symptom burden, and lung function at screening.
排除标准
- •Current or past asthma, or other clinically significant respiratory disease that may confound assessment.
- •Clinically significant uncontrolled comorbidities that increase risk or interfere with participation/outcomes.
- •Immunodeficiency/immune dysregulation, active autoimmune disease requiring systemic immunosuppression, or significant opportunistic infection history.
- •Active clinically significant infection or recent infection requiring systemic therapy; recent protocol-defined COPD exacerbation.
- •Current/recent malignancy (except low-risk, adequately treated cancers per protocol) or clinically significant abnormal screening labs.
- •Prohibited recent vaccines or therapies, prior relevant biologic/targeted therapy exposure, severe hypersensitivity to biologics/IMP, pregnancy/breastfeeding, or inability to comply (including substance abuse), per investigator judgment.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo Injection, SC
干预措施: Placebo (Other)
JKN2401 Injection
Experimental
JKN2401 Injection, SC dose A
干预措施: JKN2401 Injection (Biological)
结局指标
主要结局
Annualised rate of moderate or severe COPD exacerbations
时间窗: during 52 weeks of treatment
次要结局
未报告次要终点
研究者
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