A Phase 3 Trial of JKN2401 Injection in COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

888 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2027-11-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo Injection, SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo subcutaneous injection,Q4W

JKN2401 Injection

JKN2401 Injection, SC dose A

Group Type EXPERIMENTAL

JKN2401 Injection

Intervention Type BIOLOGICAL

JKN2401 subcutaneous injection, Q4W

Interventions

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JKN2401 Injection

JKN2401 subcutaneous injection, Q4W

Intervention Type BIOLOGICAL

Placebo

Placebo subcutaneous injection,Q4W

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No