A Phase 3 Trial of JKN2401 Injection in COPD

NCT07330310 | Not Yet Recruiting Phase 3

• 1 other identifier: JKN2401-III-01
• Study Type: interventional
• Target: 888
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

JKN2401

Outcome Measures

Primary Outcomes (1)

• Annualised rate of moderate or severe COPD exacerbations

  during 52 weeks of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo Injection, SC

Other: Placebo

JKN2401 Injection

EXPERIMENTAL

JKN2401 Injection, SC dose A

Biological: JKN2401 Injection

Interventions

JKN2401 Injection BIOLOGICAL

JKN2401 subcutaneous injection, Q4W

JKN2401 Injection

Placebo OTHER

Placebo subcutaneous injection,Q4W

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joincare Pharmaceutical Group Industry Co., Ltd: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ying Yang

CONTACT

+86-0755-33268688; overseas@joincare.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-12