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NCT06961214PHASE3Recruiting

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

GlaxoSmithKline

Start Date

6/23/2025

Completion Date

8/21/2029

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 Criteria

Age Range: 40 years to 80 years

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)

Interventions

DRUG

Depemokimab

DRUG

Placebo

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Conditions

Pulmonary Disease, Chronic Obstructive

Locations

GSK Investigational Site

Sheffield, Alabama 35660

United States

GSK Investigational Site

Aurora, Colorado 80012

United States

GSK Investigational Site

Brooksville, Florida 346135

United States

GSK Investigational Site

Doral, Florida 33172

United States

GSK Investigational Site

Fort Lauderdale, Florida 33316

United States

GSK Investigational Site

Miami, Florida 33122

United States

GSK Investigational Site

Miami, Florida 33125

United States

GSK Investigational Site

Miami, Florida 33155

United States

GSK Investigational Site

Miami, Florida 33165

United States

GSK Investigational Site

Miami, Florida 33175

United States

GSK Investigational Site

Miami, Florida 33176

United States

GSK Investigational Site

Miami, Florida 33176

United States

GSK Investigational Site

Miami Lakes, Florida 33016

United States

GSK Investigational Site

Naples, Florida 34102

United States

GSK Investigational Site

New Port Richey, Florida 34653

United States

GSK Investigational Site

Ocala, Florida 34471

United States

GSK Investigational Site

Orlando, Florida 32825

United States

GSK Investigational Site

Ormond Beach, Florida 32174

United States

GSK Investigational Site

Palmetto Bay, Florida 33157

United States

GSK Investigational Site

St. Petersburg, Florida 33704

United States

GSK Investigational Site

Adairsville, Georgia 30103

United States

GSK Investigational Site

Cordele, Georgia 31015

United States

GSK Investigational Site

East Point, Georgia 30344

United States

GSK Investigational Site

Morrow, Georgia 30260

United States

GSK Investigational Site

Boise, Idaho 83702

United States

GSK Investigational Site

Chicago, Illinois 60608

United States

GSK Investigational Site

Baton Rouge, Louisiana 70816

United States

GSK Investigational Site

Lafayette, Louisiana 70506

United States

GSK Investigational Site

Shreveport, Louisiana 71105

United States

GSK Investigational Site

Bangor, Maine 04401

United States

GSK Investigational Site

Rockville, Maryland 20854

United States

GSK Investigational Site

Allen Park, Michigan 48101

United States

GSK Investigational Site

Detroit, Michigan 48202

United States

GSK Investigational Site

Garden City, Michigan 48135

United States

GSK Investigational Site

Troy, Michigan 48085

United States

GSK Investigational Site

Las Vegas, Nevada 89144

United States

GSK Investigational Site

Moorestown, New Jersey 08057

United States

GSK Investigational Site

Sewell, New Jersey 08080

United States

GSK Investigational Site

Mount Kisco, New York 10549

United States

GSK Investigational Site

New Windsor, New York 12553

United States

GSK Investigational Site

Shelby, North Carolina 28152

United States

GSK Investigational Site

DuBois, Pennsylvania 15801

United States

GSK Investigational Site

Philadelphia, Pennsylvania 19140

United States

GSK Investigational Site

Spartanburg, South Carolina 29303

United States

GSK Investigational Site

Union, South Carolina 29379

United States

GSK Investigational Site

Knoxville, Tennessee 37919

United States

GSK Investigational Site

Austin, Texas 78744

United States

GSK Investigational Site

Dallas, Texas 75254

United States

GSK Investigational Site

El Paso, Texas 79902-1123

United States

GSK Investigational Site

Houston, Texas 77094

United States

GSK Investigational Site

Lampasas, Texas 76550

United States

GSK Investigational Site

Richmond, Texas 77407

United States

GSK Investigational Site

San Antonio, Texas 78229

United States

GSK Investigational Site

Webster, Texas 77598

United States

GSK Investigational Site

Morgantown, West Virginia 26505-0423

United States

GSK Investigational Site

Buenos Aires, C1425BAD

Argentina

GSK Investigational Site

Buenos Aires, C1426ABP

Argentina

GSK Investigational Site

Córdoba, X5800AEV

Argentina

GSK Investigational Site

Quilmes, 1878

Argentina

GSK Investigational Site

Santa Fe, S3000ASF

Argentina

GSK Investigational Site

Coffs Harbour, New South Wales 2450

Australia

GSK Investigational Site

Maroubra, New South Wales 2035

Australia

GSK Investigational Site

Westmead, New South Wales 2145

Australia

GSK Investigational Site

Midland, Western Australia 6056

Australia

GSK Investigational Site

Graz, 8036

Austria

GSK Investigational Site

Innsbruck, 6020

Austria

GSK Investigational Site

Klagenfurt, 9020

Austria

GSK Investigational Site

Linz, 4020

Austria

GSK Investigational Site

Linz, 4020

Austria

GSK Investigational Site

Linz, 4021

Austria

GSK Investigational Site

Vienna, A-1090

Austria

GSK Investigational Site

Dupnitsa, 2600

Bulgaria

GSK Investigational Site

Haskovo, 6300

Bulgaria

GSK Investigational Site

Lovech, 5500

Bulgaria

GSK Investigational Site

Montana, 3400

Bulgaria

GSK Investigational Site

Montana, 3400

Bulgaria

GSK Investigational Site

Pleven, 5800

Bulgaria

GSK Investigational Site

Rousse, 7002

Bulgaria

GSK Investigational Site

Rousse, 7002

Bulgaria

GSK Investigational Site

Sofia, 1510

Bulgaria

GSK Investigational Site

Sofia, 1680

Bulgaria

GSK Investigational Site

Jindřichův Hradec, 377 01

Czechia

GSK Investigational Site

Kralupy nad Vltavou, 278 01

Czechia

GSK Investigational Site

Nymburk, 288 02

Czechia

GSK Investigational Site

Prague, 12000

Czechia

GSK Investigational Site

Varnsdorf, 407 47

Czechia

GSK Investigational Site

Munich, Bavaria 80335

Germany

GSK Investigational Site

Offenbach, Hesse 63065

Germany

GSK Investigational Site

Rheine, North Rhine-Westphalia 48431

Germany

GSK Investigational Site

Bendorf, 56170

Germany

GSK Investigational Site

Berlin, 10119

Germany

GSK Investigational Site

Berlin, 10625

Germany

GSK Investigational Site

Berlin, 10717

Germany

GSK Investigational Site

Berlin, 10961

Germany

GSK Investigational Site

Berlin, 12203

Germany

GSK Investigational Site

Berlin, 12627

Germany

GSK Investigational Site

Berlin, 13187

Germany

GSK Investigational Site

Darmstadt, 64283

Germany

GSK Investigational Site

Essen, 45127

Germany

GSK Investigational Site

Fürstenwalde, 15517

Germany

GSK Investigational Site

Geesthacht, 21502

Germany

GSK Investigational Site

Giessen, 35392

Germany

GSK Investigational Site

Halle, 6108

Germany

GSK Investigational Site

Immenhausen, 34376

Germany

GSK Investigational Site

Leipzig, 04207

Germany

GSK Investigational Site

Leipzig, 04299

Germany

GSK Investigational Site

Leipzig, 04347

Germany

GSK Investigational Site

Lübeck, 23552

Germany

GSK Investigational Site

Schleswig, 24837

Germany

GSK Investigational Site

Exochi, Thessaloniki 57010

Greece

GSK Investigational Site

Alexandroupoli, 68100

Greece

GSK Investigational Site

Athens, 115 21

Greece

GSK Investigational Site

Ioannina, 45500

Greece

GSK Investigational Site

Marousi, 151 25

Greece

GSK Investigational Site

Ashkelon, 7830604

Israel

GSK Investigational Site

Beer-Yaakov, 703000

Israel

GSK Investigational Site

Beersheba, 84101

Israel

GSK Investigational Site

Haifa, 30000

Israel

GSK Investigational Site

Haifa, 3109601

Israel

GSK Investigational Site

Haifa, 3436212

Israel

GSK Investigational Site

Jerusalem, 90000

Israel

GSK Investigational Site

Jerusalem, 91031

Israel

GSK Investigational Site

Kfar Saba, 44281

Israel

GSK Investigational Site

Petah Tikva, 49100

Israel

GSK Investigational Site

Ramat Gan, 52621

Israel

GSK Investigational Site

Catania, 95123

Italy

GSK Investigational Site

Ferrara, 44124

Italy

GSK Investigational Site

Foggia, 71122

Italy

GSK Investigational Site

Genova, 16132

Italy

GSK Investigational Site

Roma, 00128

Italy

GSK Investigational Site

Roma, 00133

Italy

GSK Investigational Site

Roma, 00161

Italy

GSK Investigational Site

Telese Terme, 82037

Italy

GSK Investigational Site

Daugavpils, LV5410

Latvia

GSK Investigational Site

Riga, LV 1079

Latvia

GSK Investigational Site

Riga, LV-1002

Latvia

GSK Investigational Site

Takapuna, Auckland 0622

New Zealand

GSK Investigational Site

Auckland, 1051

New Zealand

GSK Investigational Site

Auckland, 1051

New Zealand

GSK Investigational Site

Christchurch, 8023

New Zealand

GSK Investigational Site

Ebdentown, 5018

New Zealand

GSK Investigational Site

Hamilton, 3240

New Zealand

GSK Investigational Site

Rotorua, 3010

New Zealand

GSK Investigational Site

Oradea, Bihor County 410155

Romania

GSK Investigational Site

Oradea, Bihor County 410176

Romania

GSK Investigational Site

Timișoara, Timiș County 300310

Romania

GSK Investigational Site

Bucharest, 061692

Romania

GSK Investigational Site

Cluj-Napoca, 400275

Romania

GSK Investigational Site

Cluj-Napoca, 400371

Romania

GSK Investigational Site

Constanța, 900002

Romania

GSK Investigational Site

Seoul, 03181

South Korea

GSK Investigational Site

Seoul, 5030

South Korea

GSK Investigational Site

Corby, NN17 2UR

United Kingdom

GSK Investigational Site

Dagenham, RM9 5NH

United Kingdom

GSK Investigational Site

Glasgow, G20 7BE

United Kingdom

GSK Investigational Site

Glasgow, G4 0SF

United Kingdom

GSK Investigational Site

London, N8 0RA

United Kingdom

GSK Investigational Site

London, NW10 2PB

United Kingdom

GSK Investigational Site

Uxbridge, UB8 3NN

United Kingdom