A Phase 2 Trial of JKN24011 in COPD

NCT07440524 | Active Not Recruiting Phase 2

• 1 other identifier: JKN2401-Ⅱ
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Subcutaneous JKN24011 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

JKN2401; JKN24011; TSLP

Outcome Measures

Primary Outcomes (1)

• Annualised rate of moderate or severe COPD exacerbations

  Through the 52-week treatment period

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo Injection, SC

Other: Placebo

JKN24011 A

EXPERIMENTAL

JKN24011,SC,DOSE A

Biological: JKN24011

JKN24011 B

EXPERIMENTAL

JKN24011, SC, DOSE B

Biological: JKN24011

Interventions

JKN24011 BIOLOGICAL

JKN24011 subcutaneous injection,Q4W

JKN24011 A; JKN24011 B

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

Study Sites (1)

Huadong Hospital, Fudan University

Shanghai, 200040, China

Location

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: February 23, 2026
• First Posted: February 27, 2026
• Study Start: August 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)