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Clinical Trials in China / NCT06959095
Recruiting Phase 3

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)

NCT06959095 · tracked via the Priya Life Science China tracker
Sponsor
GlaxoSmithKline
Phase
Phase 3
Started
2025-06-20
Last updated
2025-10-08

Condition(s) studied

Pulmonary Disease, Chronic Obstructive

Investigational drug(s) / intervention(s)

DepemokimabPlacebo

Depemokimab: Depemokimab as a sterile liquid formulation will be administered.

Placebo: Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered.

Study summary

Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the informed consent. * Elevated blood eosinophil count (BEC). * Moderate to severe COPD with frequent exacerbations, defined as: * A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year * A post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than (\<) 0.70 and a post- bronchodilator FEV1 \>30 percent (%) and \<= 80% predicted normal values * A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening * COPD assessment test (CAT) score \>=10 at Visit 1. * Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years. * Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1. * Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2). * Male or eligible female participants. Exclusion Criteria: The following subjects are excluded: * Participants with a current or prior physician diagnosis of asthma. * Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. * Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1. * Lung resection: Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure. * Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1. * Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day. * Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension * Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\]). * Unstable cardiovascular disease or arrhythmia. * Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1).

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
GSK Investigational Site Loxahatchee Groves Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Rock Hill South Carolina Recruiting
GSK Investigational Site Corsicana Texas Recruiting
GSK Investigational Site Changsha Hunan Recruiting
GSK Investigational Site Chengdu Sichuan Recruiting
GSK Investigational Site Chengdu China Recruiting
GSK Investigational Site Guangzhou China Recruiting
GSK Investigational Site Hangzhou China Recruiting
GSK Investigational Site Jiangmen China Recruiting
GSK Investigational Site Jiangxi China Recruiting
GSK Investigational Site Mianyang China Recruiting
GSK Investigational Site Qingyuan China Recruiting
GSK Investigational Site Zigong China Recruiting
GSK Investigational Site Tokyo Japan Recruiting

More GlaxoSmithKline trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06959095 on ClinicalTrials.gov ↗ ← All trials in China