RecruitingPhase 3NCT06961214

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

Sponsor

GlaxoSmithKline

Enrollment

960 participants

Start Date

Jun 23, 2025

Study Type

INTERVENTIONAL

Conditions

Pulmonary Disease, Chronic Obstructive

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

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether depemokimab — a once-yearly injection that targets a protein called IL-5 involved in allergic inflammation — can help people with moderate to severe COPD (chronic obstructive pulmonary disease) who have high levels of a type of immune cell called eosinophils. The goal is to see if this drug reduces flare-ups (called exacerbations) of COPD. **You may be eligible if...** - You are between 40 and 80 years old - You have been diagnosed with COPD for at least 1 year - You have moderate to severe COPD with reduced lung function and at least 2 moderate flare-ups or 1 severe flare-up in the past year - You have elevated eosinophil counts in your blood - You are already on triple inhaler therapy (ICS + LABA + LAMA) for at least 6 months - You have a history of smoking (at least 10 pack-years) **You may NOT be eligible if...** - You have been diagnosed with asthma - You have severe pulmonary hypertension or right-sided heart failure - You require oxygen more than 12 hours per day - You are on a breathing machine (BiPAP or CPAP) for chronic CO2 buildup - You have an active parasitic infection or unstable heart disease - You had a lung infection or COPD flare-up within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDepemokimab

Depemokimab as a sterile liquid formulation will be administered.

DRUGPlacebo

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

Locations(159)

GSK Investigational Site

Sheffield, Alabama, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Brooksville, Florida, United States

GSK Investigational Site

Doral, Florida, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami Lakes, Florida, United States

GSK Investigational Site

Naples, Florida, United States

GSK Investigational Site

New Port Richey, Florida, United States

GSK Investigational Site

Ocala, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Ormond Beach, Florida, United States

GSK Investigational Site

Palmetto Bay, Florida, United States

GSK Investigational Site

St. Petersburg, Florida, United States

GSK Investigational Site

Adairsville, Georgia, United States

GSK Investigational Site

Cordele, Georgia, United States

GSK Investigational Site

East Point, Georgia, United States

GSK Investigational Site

Morrow, Georgia, United States

GSK Investigational Site

Boise, Idaho, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Baton Rouge, Louisiana, United States

GSK Investigational Site

Lafayette, Louisiana, United States

GSK Investigational Site

Shreveport, Louisiana, United States

GSK Investigational Site

Bangor, Maine, United States

GSK Investigational Site

Rockville, Maryland, United States

GSK Investigational Site

Allen Park, Michigan, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

Garden City, Michigan, United States

GSK Investigational Site

Troy, Michigan, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Moorestown, New Jersey, United States

GSK Investigational Site

Sewell, New Jersey, United States

GSK Investigational Site

Mount Kisco, New York, United States

GSK Investigational Site

New Windsor, New York, United States

GSK Investigational Site

Shelby, North Carolina, United States

GSK Investigational Site

DuBois, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

GSK Investigational Site

Union, South Carolina, United States

GSK Investigational Site

Knoxville, Tennessee, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

El Paso, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Lampasas, Texas, United States

GSK Investigational Site

Richmond, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Webster, Texas, United States

GSK Investigational Site

Morgantown, West Virginia, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Quilmes, Argentina

GSK Investigational Site

Santa Fe, Argentina

GSK Investigational Site

Coffs Harbour, New South Wales, Australia

GSK Investigational Site

Maroubra, New South Wales, Australia

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Westmead, New South Wales, Australia

GSK Investigational Site

Midland, Western Australia, Australia

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Graz, Austria

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Innsbruck, Austria

GSK Investigational Site

Klagenfurt, Austria

GSK Investigational Site

Linz, Austria

GSK Investigational Site

Linz, Austria

GSK Investigational Site

Linz, Austria

GSK Investigational Site

Vienna, Austria

GSK Investigational Site

Dupnitsa, Bulgaria

GSK Investigational Site

Haskovo, Bulgaria

GSK Investigational Site

Lovech, Bulgaria

GSK Investigational Site

Montana, Bulgaria

GSK Investigational Site

Montana, Bulgaria

GSK Investigational Site

Pleven, Bulgaria

GSK Investigational Site

Rousse, Bulgaria

GSK Investigational Site

Rousse, Bulgaria

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

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

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Offenbach, Hesse, Germany

GSK Investigational Site

Rheine, North Rhine-Westphalia, Germany

GSK Investigational Site

Bendorf, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Darmstadt, Germany

GSK Investigational Site

Essen, Germany

GSK Investigational Site

Fürstenwalde, Germany

GSK Investigational Site

Geesthacht, Germany

GSK Investigational Site

Giessen, Germany

GSK Investigational Site

Halle, Germany

GSK Investigational Site

Immenhausen, Germany

GSK Investigational Site

Leipzig, Germany

GSK Investigational Site

Leipzig, Germany

GSK Investigational Site

Leipzig, Germany

GSK Investigational Site

Lübeck, Germany

GSK Investigational Site

Schleswig, Germany

GSK Investigational Site

Exochi, Thessaloniki, Greece

GSK Investigational Site

Alexandroupoli, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Ioannina, Greece

GSK Investigational Site

Marousi, Greece

GSK Investigational Site

Ashkelon, Israel

GSK Investigational Site

Beer-Yaakov, Israel

GSK Investigational Site

Beersheba, Israel

GSK Investigational Site

Haifa, Israel

GSK Investigational Site

Haifa, Israel

GSK Investigational Site

Haifa, Israel

GSK Investigational Site

Jerusalem, Israel

GSK Investigational Site

Jerusalem, Israel

GSK Investigational Site

Kfar Saba, Israel

GSK Investigational Site

Petah Tikva, Israel

GSK Investigational Site

Ramat Gan, Israel

GSK Investigational Site

Catania, Italy

GSK Investigational Site

Ferrara, Italy

GSK Investigational Site

Foggia, Italy

GSK Investigational Site

Genova, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Telese Terme, Italy

GSK Investigational Site

Daugavpils, Latvia

GSK Investigational Site

Riga, Latvia

GSK Investigational Site

Riga, Latvia

GSK Investigational Site

Takapuna, Auckland, New Zealand

GSK Investigational Site

Auckland, New Zealand

GSK Investigational Site

Auckland, New Zealand

GSK Investigational Site

Christchurch, New Zealand

GSK Investigational Site

Ebdentown, New Zealand

GSK Investigational Site

Hamilton, New Zealand

GSK Investigational Site

Rotorua, New Zealand

GSK Investigational Site

Oradea, Bihor County, Romania

GSK Investigational Site

Oradea, Bihor County, Romania

GSK Investigational Site

Timișoara, Timiș County, Romania

GSK Investigational Site

Bucharest, Romania

GSK Investigational Site

Cluj-Napoca, Romania

GSK Investigational Site

Cluj-Napoca, Romania

GSK Investigational Site

Constanța, Romania

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Corby, United Kingdom

GSK Investigational Site

Dagenham, United Kingdom

GSK Investigational Site

Glasgow, United Kingdom

GSK Investigational Site

Glasgow, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Uxbridge, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06961214

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