Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab in Adult Participants With COPD With Type 2 Inflammation
GlaxoSmithKline
960 participants
Jun 23, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- 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 Criteria11
- 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)
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Interventions
Depemokimab as a sterile liquid formulation will be administered.
Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered
Locations(159)
View Full Details on ClinicalTrials.gov
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NCT06961214