NCT07330310Not yet recruitingPhase 3
A Phase 3 Trial of JKN2401 Injection in COPD
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)
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 888 (estimated)
- First submitted
- 29 Dec 2025
- Start date
- Mar 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
- Diseases
- COPD
- NCT number
- NCT07330310
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 888
- From Mar 2026 to the primary completion date, Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Current or past asthma, or other clinically significant respiratory disease that may confound assessment.
- 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.
Other
- Clinically significant uncontrolled comorbidities that increase risk or interfere with participation/outcomes.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.