NCT07351734招募中2 期
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of JKN2403 Tablets 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 120 人开始时间: 2025年11月6日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
The goal of this clinical trial is to learn if drug JKN2403 works to treat moderate-to-severe COPD in adults. It will also learn about the safety and pharmacokinetic characteristics of drug JKN2403. The main questions it aims to answer are:
Does drug JKN2403 reduce the incidence of AECOPD or improve the quality of life or alleviate symptoms related to COPD?
Researchers will compare drug JKN2403 to a placebo (a look-alike substance that contains no drug) to see if drug JKN2403 works to treat moderate-to-severe COPD.
Participants will:
Take drug JKN2403 or a placebo every day for 24 weeks Visit the clinic once every four weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
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).
- •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.
研究者
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