NCT07351734RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 10 Jan 2026
- Start date
- 6 Nov 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
- Diseases
- COPD
- NCT number
- NCT07351734
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 6 Nov 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Clinically significant uncontrolled comorbidities that increase risk or interfere with participation/outcomes.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.