A Phase 3 Trial of JKN2401 Injection in COPD

Joincare Pharmaceutical Group Industry Co., Ltd

Status and phase: Begins enrollment this month; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Other: Placebo; Biological: JKN2401 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07330310

JKN2401-III-01

Details and patient eligibility

About

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)

Enrollment: 888 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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888 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo Injection, SC

Treatment:

Other: Placebo

JKN2401 Injection

Experimental group

Description:

JKN2401 Injection, SC dose A

Treatment:

Biological: JKN2401 Injection