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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

960

Start Date

2025-06-23

Completion Date

2029-08-21

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

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 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)

Locations (159)

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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St. Petersburg, Florida, United States

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Adairsville, Georgia, United States

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Cordele, Georgia, United States

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East Point, 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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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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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Córdoba, Argentina

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Quilmes, Argentina

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Santa 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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Graz, Austria

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Innsbruck, Austria

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Klagenfurt, Austria

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Linz, 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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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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Jindřichův Hradec, Czechia

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Kralupy nad Vltavou, Czechia

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Nymburk, Czechia

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Prague, Czechia

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Varnsdorf, Czechia

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Munich, Bavaria, Germany

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Offenbach, Hesse, Germany

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Rheine, North Rhine-Westphalia, Germany

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Bendorf, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Darmstadt, Germany

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Essen, Germany

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Fürstenwalde, Germany

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Geesthacht, Germany

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Giessen, Germany

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Halle, Germany

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Immenhausen, Germany

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Leipzig, Germany

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Leipzig, Germany

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Leipzig, Germany

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Lübeck, Germany

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Schleswig, Germany

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Exochi, Thessaloniki, Greece

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Alexandroupoli, Greece

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Athens, Greece

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Ioannina, Greece

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Marousi, Greece

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Ashkelon, Israel

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Beer-Yaakov, Israel

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Beersheba, Israel

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Haifa, Israel

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Haifa, Israel

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Haifa, Israel

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Jerusalem, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Catania, Italy

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Ferrara, Italy

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Foggia, Italy

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Genova, Italy

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Roma, Italy

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Roma, Italy

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Roma, Italy

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Telese Terme, Italy

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Daugavpils, Latvia

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Riga, Latvia

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Riga, Latvia

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Takapuna, Auckland, New Zealand

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Auckland, New Zealand

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Auckland, New Zealand

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Christchurch, New Zealand

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Ebdentown, New Zealand

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Hamilton, New Zealand

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Rotorua, New Zealand

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Oradea, Bihor County, Romania

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Oradea, Bihor County, Romania

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Timișoara, Timiș County, Romania

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Bucharest, Romania

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Cluj-Napoca, Romania

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Cluj-Napoca, Romania

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Constanța, Romania

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Seoul, South Korea

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Seoul, South Korea

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Corby, United Kingdom

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Dagenham, United Kingdom

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Glasgow, United Kingdom

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Glasgow, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Uxbridge, United Kingdom

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 (159)