Actively Recruiting
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)
Led by Joincare Pharmaceutical Group Industry Co., Ltd · Updated on 2026-01-20
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug JKN2403 in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD). The study aims to see if JKN2403 reduces the number of flare-ups (acute exacerbations) or improves quality of life and symptoms related to COPD. This phase IIa trial will also study the safety and how the body processes JKN2403, comparing it to a placebo that contains no active drug. Participants will be randomly assigned to one of four groups: three different doses of JKN2403 tablets taken once daily by mouth for 24 weeks, or a placebo taken once daily for 24 weeks. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Regular clinic visits will happen every four weeks during the treatment period. During the trial, participants will have checkups and tests at each visit, keep a diary of their symptoms, and record how often they use rescue inhalers. Researchers will measure flare-up rates, lung function (using pre-bronchodilator FEV1), quality of life scores, and time to first flare-up over the treatment period. The study plans to follow participants for up to 24 months to assess these outcomes and monitor safety.
CONDITIONS
Brief Title
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and are willing to follow study procedures
- Adults with a documented diagnosis of COPD consistent with guideline criteria
- Have a relevant exposure history such as smoking
- Receiving stable, guideline-based maintenance COPD therapy before randomization
- Meet protocol-defined exacerbation history, symptom burden, and lung function at screening
You will not qualify if you...
- Current or past asthma or other significant respiratory diseases that may affect assessment
- Uncontrolled comorbidities that increase risk or interfere with participation or outcomes
- Immunodeficiency, active autoimmune disease needing systemic immunosuppression, or significant history of opportunistic infections
- Active significant infection or recent infection needing systemic therapy; recent COPD exacerbation as defined by protocol
- Recent or current malignancy (except low-risk treated cancers) or abnormal screening labs
- Recent prohibited vaccines or therapies, prior relevant biologic or targeted therapy exposure, severe hypersensitivity to biologics or investigational medicinal products
- Pregnancy, breastfeeding, or inability to comply including substance abuse as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive JKN2403 Tablets or placebo once daily orally as part of the study treatment.
Visits at weeks 4, 8, 12, 16, 20, and 24 for assessments
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
W
Weijie Guan Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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