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)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07330310

Enrollment

888

Registered

2026-01-09

Start date

2026-03-31

Completion date

2027-11-30

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

JKN2401

Brief summary

Interventions

BIOLOGICALJKN2401 Injection

JKN2401 subcutaneous injection, Q4W

OTHERPlacebo

Placebo subcutaneous injection,Q4W

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Annualised rate of moderate or severe COPD exacerbations	during 52 weeks of treatment

Contacts

Primary ContactYing Yang

overseas@joincare.com+86-0755-33268688

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026