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OpenTrials
Active, Not Recruiting

NCT Number: NCT07440524

A Phase 2 Trial of JKN24011 in COPD

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Huadong Hospital, Fudan University

Shanghai, 200040, China

About this study

JKN24011 targets TSLP

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JKN24011

Biological

JKN24011 subcutaneous injection,Q4W

Placebo

Other

Placebo subcutaneous injection,Q4W

Primary outcomes

  1. Annualised rate of moderate or severe COPD exacerbations

    Time frame: Through the 52-week treatment period

Sponsors and collaborators

Lead sponsor

Joincare Pharmaceutical Group Industry Co., Ltd

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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