A Phase 3 Trial of JKN2401 Injection in COPD
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorJoincare Pharmaceutical Group Industry Co., Ltd
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
JKN2401 Injection
Biological/VaccineJKN2401 subcutaneous injection, Q4W
Placebo
Other interventionPlacebo subcutaneous injection,Q4W
Treatment groups
888 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: JKN2401 InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Annualised rate of moderate or severe COPD exacerbations
Time frame
during 52 weeks of treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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