Overview
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
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.