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RECRUITING

NCT07177339

PHASE3

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study of the Efficacy and Safety of Early Depemokimab Initiation as add-on Treatment in COPD Patients With Type 2 Inflammation

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1196

Start Date

2025-10-20

Completion Date

2029-06-08

Last Updated

2026-07-28

Healthy Volunteers

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Depemokimab

Depemokimab will be administered.

DRUG

Placebo

Matching placebo will be administered.

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

Locations (121)

GSK Investigational Site

Newport Beach, California, United States

GSK Investigational Site

Lakewood, Colorado, United States

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Brandon, Florida, United States

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Crystal River, Florida, United States

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Doral, Florida, United States

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Greenacres City, Florida, United States

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Hialeah, Florida, United States

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Hollywood, 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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Orlando, Florida, United States

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Cordele, Georgia, United States

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Dunwoody, Georgia, United States

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Boise, Idaho, United States

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Bowling Green, Kentucky, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Bangor, Maine, United States

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Allen Park, Michigan, United States

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Clarkston, Michigan, United States

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Dearborn, Michigan, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Winston-Salem, North Carolina, United States

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Edmond, Oklahoma, United States

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DuBois, Pennsylvania, United States

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West Chester, Pennsylvania, United States

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Greenville, South Carolina, United States

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Rock Hill, South Carolina, United States

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Knoxville, Tennessee, United States

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Dallas, Texas, United States

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DeSoto, Texas, United States

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Greenville, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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Mesquite, Texas, United States

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Stafford, Texas, United States

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Coffs Harbour, New South Wales, Australia

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Spearwood, Western Australia, Australia

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Haskovo, Bulgaria

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Montana, 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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Kingston, Ontario, Canada

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Windsor, Ontario, Canada

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Shapingba, Chongqing Municipality, China

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Nanning, Guangxi, China

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Chengdu, Sichuan, China

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Chengdu, Sichuan, China

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Suining, Sichuan, China

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Beijing, China

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Beijing, China

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Changchun, China

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Changchun, China

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Changsha, China

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Chengdu, China

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Chongqing, China

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Dongguan, China

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Fujian, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Guilin, China

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Haikou, China

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Hangzhou, China

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Harbin, China

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Hefei, China

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Hohhot, China

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Huizhou, China

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Jiangmen, China

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Jiangmen, China

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Jinzhou, China

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Nanchang, China

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Nanchang, China

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Nanjing, China

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Qinhuangdao, China

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Shanghai, China

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Shanghai, China

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Shijiazhuang, China

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Shijiazhuang, China

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Taiyuan, China

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Taizhou, China

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Taizhou, China

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Ürümqi, China

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Weifang, China

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Wenzhou, China

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Xiamen, China

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Xinxiang, China

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Yinchuan, China

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Zunyi, China

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Berlin, Germany

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Berlin, Germany

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Frankfurt, Germany

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Frankfurt, Germany

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Mainz, Germany

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München, Germany

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Palaió Fáliro, Anatoliki Attiki, Greece

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Ioannina, Greece

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Thessaloniki, Greece

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Ramat Gan, Israel

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Tel Aviv, Israel

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Gifu, Japan

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Mie, Japan

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Tokyo, Japan

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Ebdentown, Upper Hutt, New Zealand

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Rotorua, New Zealand

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Bialystok, Poland

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Rzeszów, Poland

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Palma de Mallorca, Spain

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Bedford, United Kingdom

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Bradford, United Kingdom

GSK Investigational Site

Corby, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (121)