RecruitingPhase 2NCT07351734

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


Sponsor

Joincare Pharmaceutical Group Industry Co., Ltd

Enrollment

120 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing JKN2403, an experimental drug, for people with chronic obstructive pulmonary disease (COPD) — a lung condition that makes it hard to breathe. This is an early-phase trial comparing the drug to a placebo to see if it is safe and reduces COPD symptoms and flare-ups. **You may be eligible if:** - You are an adult with a confirmed COPD diagnosis - You have a history of cigarette smoking or other significant exposure known to cause COPD - You are on a stable, guideline-recommended COPD treatment - You have had COPD flare-ups or significant symptoms as defined by the study **You may NOT be eligible if:** - You have a history of asthma or another significant lung condition that could confuse the results - You have uncontrolled serious medical problems - You have immune system problems, active autoimmune disease, or a history of serious infections - You have had a recent COPD flare-up or active infection - You have had a recent cancer diagnosis (except certain low-risk, treated cancers) - You are pregnant or breastfeeding - You have received certain biologic drugs or vaccines recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJKN2403 Tablets

JKN2403 Tablets once daily orally, for 24 weeks

DRUGPlacebo

Placebo


Locations(1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT07351734


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