Ireland
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Recruiting Phase 2

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD

NCT07351734 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-11-06
Last updated
2026-01-20

Condition(s) studied

COPD (Chronic Obstructive Pulmonary Disease)

Investigational drug(s) / intervention(s)

JKN2403 TabletsPlacebo

JKN2403 Tablets: JKN2403 Tablets once daily orally, for 24 weeks

Placebo: Placebo

Study 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

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
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.

Primary outcome measure(s)

  • The annualized incidence rate of moderate to severe AECOPD — at 24 months
  • The duration from the first administration to the first occurrence of moderate to severe AECOPD — at 24 months

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07351734 on ClinicalTrials.gov ↗ ← All trials in China