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RECRUITING

NCT06961214

PHASE3

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

961

Start Date

2025-06-23

Completion Date

2029-02-14

Last Updated

2026-10-05

Healthy Volunteers

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

BIOLOGICAL

Depemokimab

Depemokimab as a sterile liquid formulation will be administered.

DRUG

Placebo

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

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)

Locations (193)

GSK Investigational Site

Sheffield, Alabama, United States

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Aurora, Colorado, United States

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Brooksville, Florida, United States

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Doral, Florida, United States

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Fort Lauderdale, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Naples, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Palmetto Bay, Florida, United States

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Pembroke Pines, Florida, United States

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St. Petersburg, Florida, United States

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Adairsville, Georgia, United States

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Atlanta, Georgia, United States

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Cordele, Georgia, United States

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Morrow, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Baton Rouge, Louisiana, United States

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Lafayette, Louisiana, United States

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Shreveport, Louisiana, United States

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Bangor, Maine, United States

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Rockville, Maryland, United States

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Fall River, Massachusetts, United States

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Allen Park, Michigan, United States

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Detroit, Michigan, United States

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Garden City, Michigan, United States

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Troy, Michigan, United States

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Las Vegas, Nevada, United States

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Moorestown, New Jersey, United States

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Sewell, New Jersey, United States

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Mount Kisco, New York, United States

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New Windsor, New York, United States

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Shelby, North Carolina, United States

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DuBois, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Spartanburg, South Carolina, United States

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Union, South Carolina, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Lampasas, Texas, United States

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Richmond, Texas, United States

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San Antonio, Texas, United States

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Webster, Texas, United States

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Morgantown, West Virginia, United States

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Lobos, Buenos Aires, Argentina

GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, Argentina

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Berazategui, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Córdoba, Argentina

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Córdoba, Argentina

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Quilmes, Argentina

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Quilmes, Argentina

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Rosario, Argentina

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Rosario Provincia de Santa FE, Argentina

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Santa Fe, Argentina

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Sante Fe, Argentina

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Coffs Harbour, New South Wales, Australia

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Maroubra, New South Wales, Australia

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Westmead, New South Wales, Australia

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Midland, Western Australia, Australia

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Klagenfurt, Carinthia, Austria

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Linz, Upper Austria, Austria

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Graz, Austria

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Innsbruck, Austria

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Linz, Austria

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Linz, Austria

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Vienna, Austria

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Dupnitsa, Bulgaria

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Haskovo, Bulgaria

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Lovech, Bulgaria

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Montana, Bulgaria

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Montana, Bulgaria

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Pazardzhik, Bulgaria

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Pleven, Bulgaria

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Rousse, Bulgaria

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Rousse, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

GSK Investigational Site

Jindřichův Hradec, Czechia

GSK Investigational Site

Kralupy nad Vltavou, Czechia

GSK Investigational Site

Nymburk, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Varnsdorf, Czechia

And 93 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (193)