NCT07351734 A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD
| NCT ID | NCT07351734 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Joincare Pharmaceutical Group Industry Co., Ltd |
| Condition | COPD (Chronic Obstructive Pulmonary Disease) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-11-06 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2025-11-06 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * Current or past asthma, or other clinically significant respiratory disease that may confound assessment. * Clinically significant uncontrolled comorbidities that increase risk or interfere with participation/outcomes. * 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. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07351734 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying COPD (Chronic Obstructive Pulmonary Disease). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07351734 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07351734 currently recruiting?
Yes, NCT07351734 is actively recruiting participants. Contact the research team at battery203@163.com for enrollment information.
Where is the NCT07351734 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07351734 clinical trial?
NCT07351734 is sponsored by Joincare Pharmaceutical Group Industry Co., Ltd. The trial plans to enroll 120 participants.
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