Actively Recruiting
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD
Led by Joincare Pharmaceutical Group Industry Co., Ltd · Updated on 2026-01-20
120
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and follow the study procedures
- Adults diagnosed with COPD according to guideline criteria
- History of exposure consistent with COPD, such as smoking
- Receiving stable, guideline-based maintenance treatment for COPD before randomization
- Meet protocol-defined criteria for 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 could affect assessment
- Uncontrolled serious health conditions that may increase risk or interfere with study participation
- Immunodeficiency, immune disorders needing systemic immunosuppressants, or significant history of infections
- Active serious infections or recent infections needing systemic treatment; recent COPD exacerbation per protocol
- Current or recent cancer (except low-risk properly treated cancers) or abnormal screening lab results
- Recent use of prohibited vaccines or therapies, prior biologic or targeted treatments, severe allergies to study drugs
- Pregnancy, breastfeeding, substance abuse, or inability to comply with study requirements as judged by investigators
AI-Screening
AI-Powered Screening
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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
CONTACT
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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