JKN2403 for adults with moderate-to-severe COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Weijie Guan Professor
• Email: battery203@163.com
• Phone: 020-81566265

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.