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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07440524

Enrollment

215

Registered

2026-02-27

Start date

2024-08-01

Completion date

2026-05-01

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

JKN2401, JKN24011, TSLP

Brief summary

Detailed description

JKN24011 targets TSLP

Interventions

BIOLOGICALJKN24011

JKN24011 subcutaneous injection,Q4W

OTHERPlacebo

Placebo subcutaneous injection,Q4W

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Annualised rate of moderate or severe COPD exacerbations	Through the 52-week treatment period

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026