NCT07351734
Recruiting
Phase 2
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 sites120 target enrollmentStarted: November 6, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
- Enrollment
- 120
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
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