JKN2403 for adults with moderate-to-severe COPD

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)

This trial will try an oral medicine called JKN2403 to see if it reduces flare-ups and improves symptoms and quality of life in adults with moderate-to-severe COPD.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07351734 on ClinicalTrials.gov

What this trial studies

This is a randomized, double‑blind, placebo‑controlled Phase IIa trial comparing daily oral JKN2403 to a matching placebo for 24 weeks in adults with moderate-to-severe COPD. Participants will remain on stable guideline-based COPD therapy, take the study drug or placebo every day, attend clinic visits every four weeks for safety checks and tests, and keep a diary of symptoms and rescue inhaler use. The main outcomes include the rate of acute exacerbations of COPD (AECOPD), symptom measures, and quality-of-life scores, together with safety and pharmacokinetic assessments. The design aims to determine whether JKN2403 yields clinical benefit beyond standard care without unacceptable side effects.

Who should consider this trial

Good fit: Adults with a documented diagnosis of moderate-to-severe COPD, an exposure history consistent with COPD (for example, smoking), on stable maintenance COPD therapy, and meeting the protocol's symptom burden and lung function criteria.

Not a fit: People with current or past asthma, other clinically significant respiratory diseases, uncontrolled major comorbidities, immune disorders, or recent serious infections may not receive benefit or be excluded from participation.

Why it matters

Potential benefit: If successful, JKN2403 could lower the number of COPD exacerbations and improve daily symptoms and quality of life for people with moderate-to-severe disease.

How similar studies have performed: Other Phase II placebo‑controlled trials of new COPD drugs have had mixed results—some drug classes produced meaningful benefits while many candidates failed—so JKN2403 remains promising but unproven.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Weijie Guan Professor

Conditions COPD