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
Qualifiers
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
Treatments tested in this trial
- JKN2401 Injection
- Placebo
Treatment groups
888 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov