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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT06961214

Run by

GlaxoSmithKline

People needed

960

Starts

2025-06-23

Expected to finish

2029-08-21

Last updated by the study team

2026-04-09

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• GSK Investigational Site — Aurora, Colorado, United States (enrolling)
• GSK Investigational Site — Brooksville, Florida, United States (enrolling)
• GSK Investigational Site — Doral, Florida, United States (enrolling)
• GSK Investigational Site — Fort Lauderdale, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami Lakes, Florida, United States (enrolling)
• GSK Investigational Site — Naples, Florida, United States (enrolling)
• GSK Investigational Site — New Port Richey, Florida, United States (enrolling)
• GSK Investigational Site — Ocala, Florida, United States (enrolling)
• GSK Investigational Site — Orlando, Florida, United States (enrolling)
• GSK Investigational Site — Ormond Beach, Florida, United States (enrolling)
• GSK Investigational Site — Palmetto Bay, Florida, United States (enrolling)
• GSK Investigational Site — St. Petersburg, Florida, United States (enrolling)
• GSK Investigational Site — Adairsville, Georgia, United States (enrolling)
• GSK Investigational Site — Cordele, Georgia, United States (enrolling)
• GSK Investigational Site — East Point, Georgia, United States (enrolling)
• GSK Investigational Site — Morrow, Georgia, United States (enrolling)
• GSK Investigational Site — Boise, Idaho, United States (enrolling)
• GSK Investigational Site — Sheffield, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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