Status:

RECRUITING

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Pulmonary Disease, Chronic Obstructive

Eligibility:

All Genders

40-80 years

Phase:

PHASE3

Brief 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 ...

Eligibility Criteria

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 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)

Key Trial Info

Start Date :

June 23 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 21 2029

Estimated Enrollment :

960 Patients enrolled

Trial Details

Trial ID

NCT06961214

Start Date

June 23 2025

End Date

August 21 2029

Last Update

April 9 2026

Active Locations (159)

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Page 1 of 40 (159 locations)

1

GSK Investigational Site

Sheffield, Alabama, United States, 35660

2

GSK Investigational Site

Aurora, Colorado, United States, 80012

3

GSK Investigational Site

Brooksville, Florida, United States, 346135

4

GSK Investigational Site

Doral, Florida, United States, 33172