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NCT07177339PHASE3Recruiting

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation

GlaxoSmithKline

Start Date

10/20/2025

Completion Date

6/8/2029

Summary

Depemokimab is being developed as a treatment for individuals with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.

Eligibility Criteria

Age Range: 40 years to 75 years

Inclusion Criteria: * Male or eligible female participants * Eosinophilic phenotype measured using Blood Eosinophil Count (BEC) * Moderate to severe COPD, defined as * A clinically documented history of COPD for at least 1 year * A post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of less than (\<)0.70 and a post-salbutamol FEV1 greater than (\>)30 percent (%) and \<80% predicted normal values * Elevated risk for exacerbations, defined as * A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and * The presence of risk factors for future exacerbations/deterioration such as: * Modified Medical Research Council (mMRC) dyspnea score \>= 2 * COPD Assessment Test (CAT) \>= 15 * Post-bronchodilator FEV1 \< 50% predicted * Chronic bronchitis * Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at Screening. * Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist \[LABA\] or LABA+ Long-acting muscarinic receptor antagonist \[LAMA\]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the investigator for at least 3 months * Body mass index (BMI) \>=16 kilograms per square meter (kg/m\^2) Exclusion Criteria: * The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded * Participants with a current or prior physician diagnosis of asthma * Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred * Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. * COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1 * COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to 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 Visit 1 * Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded * Continuous oxygen: Participants requiring oxygen supplementation for COPD

Interventions

DRUG

Depemokimab

DRUG

Placebo

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Conditions

Pulmonary Disease, Chronic Obstructive

Locations

GSK Investigational Site

Newport Beach, California 92663

United States

GSK Investigational Site

Lakewood, Colorado 80228-1813

United States

GSK Investigational Site

Brandon, Florida 33511

United States

GSK Investigational Site

Crystal River, Florida 34429

United States

GSK Investigational Site

Doral, Florida 33172

United States

GSK Investigational Site

Greenacres City, Florida 33467

United States

GSK Investigational Site

Hialeah, Florida 33012

United States

GSK Investigational Site

Hollywood, Florida 33024

United States

GSK Investigational Site

Miami, Florida 33125

United States

GSK Investigational Site

Miami, Florida 33126

United States

GSK Investigational Site

Miami, Florida 33176

United States

GSK Investigational Site

Miami Lakes, Florida 33016

United States

GSK Investigational Site

Orlando, Florida 32825

United States

GSK Investigational Site

Cordele, Georgia 31015

United States

GSK Investigational Site

Dunwoody, Georgia 30350

United States

GSK Investigational Site

Boise, Idaho 83702

United States

GSK Investigational Site

Bowling Green, Kentucky 42101

United States

GSK Investigational Site

Lake Charles, Louisiana 70605

United States

GSK Investigational Site

Shreveport, Louisiana 71105

United States

GSK Investigational Site

Bangor, Maine 04401

United States

GSK Investigational Site

Allen Park, Michigan 48101

United States

GSK Investigational Site

Clarkston, Michigan 48346

United States

GSK Investigational Site

Dearborn, Michigan 48126

United States

GSK Investigational Site

Henderson, Nevada 89052

United States

GSK Investigational Site

Las Vegas, Nevada 89123

United States

GSK Investigational Site

Reno, Nevada 89502

United States

GSK Investigational Site

Winston-Salem, North Carolina 27103

United States

GSK Investigational Site

Edmond, Oklahoma 73013

United States

GSK Investigational Site

DuBois, Pennsylvania 15801

United States

GSK Investigational Site

West Chester, Pennsylvania 19380

United States

GSK Investigational Site

Greenville, South Carolina 29607

United States

GSK Investigational Site

Rock Hill, South Carolina 29732

United States

GSK Investigational Site

Knoxville, Tennessee 37919

United States

GSK Investigational Site

Dallas, Texas 75254

United States

GSK Investigational Site

DeSoto, Texas 75115

United States

GSK Investigational Site

Greenville, Texas 75401

United States

GSK Investigational Site

Houston, Texas 77058

United States

GSK Investigational Site

Houston, Texas 77089

United States

GSK Investigational Site

Houston, Texas 77090

United States

GSK Investigational Site

Katy, Texas 77494

United States

GSK Investigational Site

Mesquite, Texas 75149

United States

GSK Investigational Site

Stafford, Texas 77477

United States

GSK Investigational Site

Coffs Harbour, New South Wales 2450

Australia

GSK Investigational Site

Spearwood, Western Australia 6163

Australia

GSK Investigational Site

Haskovo, 6300

Bulgaria

GSK Investigational Site

Montana, 3400

Bulgaria

GSK Investigational Site

Rousse, 7002

Bulgaria

GSK Investigational Site

Sofia, 1463

Bulgaria

GSK Investigational Site

Sofia, 1510

Bulgaria

GSK Investigational Site

Sofia, 1756

Bulgaria

GSK Investigational Site

Kingston, Ontario K7M 7E4

Canada

GSK Investigational Site

Windsor, Ontario N8X 1T3

Canada

GSK Investigational Site

Shapingba, Chongqing Municipality

China

GSK Investigational Site

Nanning, Guangxi 530016

China

GSK Investigational Site

Chengdu, Sichuan 610500

China

GSK Investigational Site

Chengdu, Sichuan

China

GSK Investigational Site

Suining, Sichuan 629018

China

GSK Investigational Site

Beijing, 100020

China

GSK Investigational Site

Beijing, 100034

China

GSK Investigational Site

Changchun, 130021

China

GSK Investigational Site

Changchun, 130041

China

GSK Investigational Site

Changsha, 410013

China

GSK Investigational Site

Chengdu, 610041

China

GSK Investigational Site

Chongqing, 400042

China

GSK Investigational Site

Dongguan, 523326

China

GSK Investigational Site

Fujian, 350001

China

GSK Investigational Site

Guangzhou, 510080

China

GSK Investigational Site

Guangzhou, 510150

China

GSK Investigational Site

Guangzhou, 510180

China

GSK Investigational Site

Guilin, 541002

China

GSK Investigational Site

Haikou, 570001

China

GSK Investigational Site

Hangzhou, 310000

China

GSK Investigational Site

Harbin, 150001

China

GSK Investigational Site

Hefei, 230001

China

GSK Investigational Site

Hohhot, 010050

China

GSK Investigational Site

Huizhou, 516000

China

GSK Investigational Site

Jiangmen, 529100

China

GSK Investigational Site

Jiangmen, 529700

China

GSK Investigational Site

Jinzhou, 121000

China

GSK Investigational Site

Nanchang, 330000

China

GSK Investigational Site

Nanchang, 330006

China

GSK Investigational Site

Nanjing, 210009

China

GSK Investigational Site

Qinhuangdao, 66000

China

GSK Investigational Site

Shanghai, 200032

China

GSK Investigational Site

Shanghai, 201199

China

GSK Investigational Site

Shijiazhuang, 050000

China

GSK Investigational Site

Shijiazhuang, 050051

China

GSK Investigational Site

Taiyuan, 030001

China

GSK Investigational Site

Taizhou, 317000

China

GSK Investigational Site

Taizhou, 318000

China

GSK Investigational Site

Ürümqi, 830054

China

GSK Investigational Site

Weifang,

China

GSK Investigational Site

Wenzhou, 325000

China

GSK Investigational Site

Xiamen, 361004

China

GSK Investigational Site

Xinxiang, 453000

China

GSK Investigational Site

Yinchuan, 750001

China

GSK Investigational Site

Zunyi, 563114

China

GSK Investigational Site

Berlin, 10625

Germany

GSK Investigational Site

Berlin, 10717

Germany

GSK Investigational Site

Frankfurt, 60389

Germany

GSK Investigational Site

Frankfurt, 60596

Germany

GSK Investigational Site

Mainz, 60549

Germany

GSK Investigational Site

München, 81241

Germany

GSK Investigational Site

Palaió Fáliro, Anatoliki Attiki 175 62

Greece

GSK Investigational Site

Ioannina, 45500

Greece

GSK Investigational Site

Thessaloniki,

Greece

GSK Investigational Site

Ramat Gan, 52621

Israel

GSK Investigational Site

Tel Aviv, 64239

Israel

GSK Investigational Site

Gifu, 509-6134

Japan

GSK Investigational Site

Mie, 515-8544

Japan

GSK Investigational Site

Tokyo, 140-8522

Japan

GSK Investigational Site

Ebdentown, Upper Hutt 5018

New Zealand

GSK Investigational Site

Rotorua, 3010

New Zealand

GSK Investigational Site

Bialystok, 15-044

Poland

GSK Investigational Site

Rzeszów, 35-051

Poland

GSK Investigational Site

Barcelona,

Spain

GSK Investigational Site

Málaga, 29010

Spain

GSK Investigational Site

Palma de Mallorca, 07010

Spain

GSK Investigational Site

Bedford, MK40 2FG

United Kingdom

GSK Investigational Site

Bradford, BD9 6RJ

United Kingdom

GSK Investigational Site

Corby, NN17 2UR

United Kingdom