Tests JKN2403 tablets against a placebo in adults with COPD
Tests JKN2403 tablets against a placebo in adults with moderate-to-severe COPD.
Plain-language title generated from the registry record
Registry title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT07351734, who can take part
Where in China
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Joincare Pharmaceutical Group Industry Co., Ltd
- Trial code
- NCT07351734
- Record updated
- 20 January 2026
- Original description
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:Read full original descriptionShow less
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)
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
Inclusion: 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: 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; Current or past asthma, or other clinically significant respiratory disease that may confound assessment; 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; Clinically significant uncontrolled comorbidities that increase risk or interfere with participation/outcomes.