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Recruiting Phase 3

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

NCT06961214 · tracked via the Priya Life Science Israel tracker
Phase
Phase 3
Started
2025-06-23
Last updated
2026-10-05

Condition(s) studied

Pulmonary Disease, Chronic Obstructive

Investigational drug(s) / intervention(s)

Depemokimab →Placebo

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 compared 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 \< 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 and 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 16 hours per day to maintain resting oxygen saturation greater than 88% * 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)

  • Annualized Rate of Moderate/Severe Exacerbations — From Baseline up to Week 104
    Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \[\>=\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized exacerbation rate will be evaluated.

Trial sites (193)

FacilityCityRegionStatus
GSK Investigational Site Sheffield Alabama Recruiting
GSK Investigational Site Aurora Colorado Recruiting
GSK Investigational Site Brooksville Florida Recruiting
GSK Investigational Site Doral Florida Recruiting
GSK Investigational Site Fort Lauderdale Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Lakes Florida Recruiting
GSK Investigational Site Naples Florida Recruiting
GSK Investigational Site New Port Richey Florida Recruiting
GSK Investigational Site Ocala Florida Recruiting
GSK Investigational Site Orlando Florida Recruiting
GSK Investigational Site Ormond Beach Florida Recruiting
GSK Investigational Site Palmetto Bay Florida Recruiting
GSK Investigational Site Pembroke Pines Florida Recruiting
GSK Investigational Site St. Petersburg Florida Recruiting
GSK Investigational Site Adairsville Georgia Recruiting
GSK Investigational Site Atlanta Georgia Recruiting
GSK Investigational Site Cordele Georgia Recruiting
GSK Investigational Site Morrow Georgia Recruiting
GSK Investigational Site Boise Idaho Recruiting
GSK Investigational Site Chicago Illinois Recruiting
GSK Investigational Site Baton Rouge Louisiana Recruiting
GSK Investigational Site Lafayette Louisiana Recruiting
GSK Investigational Site Shreveport Louisiana Recruiting
GSK Investigational Site Bangor Maine Recruiting
GSK Investigational Site Rockville Maryland Recruiting
GSK Investigational Site Fall River Massachusetts Recruiting
GSK Investigational Site Allen Park Michigan Recruiting
GSK Investigational Site Detroit Michigan Recruiting
GSK Investigational Site Garden City Michigan Recruiting
GSK Investigational Site Troy Michigan Recruiting
GSK Investigational Site Las Vegas Nevada Recruiting
GSK Investigational Site Moorestown New Jersey Recruiting
GSK Investigational Site Sewell New Jersey Recruiting

+ 153 more sites — see the full list on the official registry below.

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 NCT06961214 on ClinicalTrials.gov ↗ ← All trials in Israel