A Phase 3 Trial of JKN2401 Injection in COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JKN2401 Injection, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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)
Interventions
- Biological JKN2401 Injection
JKN2401 subcutaneous injection, Q4W - Other Placebo
Placebo subcutaneous injection,Q4W
Primary outcome measures
- Annualised rate of moderate or severe COPD exacerbations [Time frame: during 52 weeks of treatment]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07330310 · JKN2401-III-01