A Phase 3 Trial of JKN2401 Injection in COPD (NCT07330310) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Phase 3 Trial of JKN2401 Injection in COPD
888 participantsStarted 2026-03
Plain-language summary
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous JKN2401 Injection in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Who can participate
Age range40 Years – 80 Years
SexALL
See this in plain English?
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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 and/or biomass exposure).
* 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.
What they're measuring
1
Annualised rate of moderate or severe COPD exacerbations
Timeframe: during 52 weeks of treatment
Trial details
NCT IDNCT07330310
SponsorJoincare Pharmaceutical Group Industry Co., Ltd