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RECRUITING

NCT06959095

PHASE3

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

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 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

981

Start Date

2025-06-20

Completion Date

2029-02-14

Last Updated

2026-10-05

Healthy Volunteers

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

BIOLOGICAL

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 less than (\<) 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 or 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 16 hours per day to maintain resting oxygen saturation greater than 88% * 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 (281)

GSK Investigational Site

Bakersfield, California, United States

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Modesto, California, United States

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Newport Beach, California, United States

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Wilmington, Delaware, United States

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Bradenton, Florida, United States

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Brandon, Florida, United States

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Hialeah, Florida, United States

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Hialeah, Florida, United States

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Loxahatchee Groves, 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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Orange City, Florida, United States

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Palm Springs, Florida, United States

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Palmetto Bay, Florida, United States

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Pensacola, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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The Villages, Florida, United States

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Riverdale, Georgia, United States

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Stonecrest, Georgia, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Clarkston, Michigan, United States

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Flint, Michigan, United States

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St Louis, Missouri, 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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North Massapequa, New York, United States

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Winston-Salem, North Carolina, United States

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Winston-Salem, North Carolina, 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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Franklin, Tennessee, United States

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Corsicana, Texas, United States

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Dallas, 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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McKinney, Texas, United States

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Pearland, Texas, United States

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La Plata, Provincia de Bs AS, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Ciudad Autonoma de Bueno, Argentina

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Mendoza, Argentina

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Mendoza, Argentina

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Paraná, Argentina

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Rosario, Argentina

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San Juan Bautista, Argentina

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San Miguel de Tucumán, Argentina

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San Miguel de Tucumán, Argentina

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San Miguel de Tucumán, Argentina

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Aalst, Belgium

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Genk, Belgium

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Kortrijk, Belgium

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Liège, Belgium

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Liège, Belgium

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Namur, Belgium

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Sint-Niklaas, Belgium

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Richmond, British Columbia, Canada

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Ajax, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Curicó, Chile

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Haikou, Hainan, China

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Changsha, Hunan, China

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Chengdu, 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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Fuyang, China

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Guangzhou, China

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Guangzhou, China

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Guilin, China

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Hangzhou, China

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Hangzhou, China

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Hefei, China

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Hohhot, China

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Hohhot, China

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Huizhou, China

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Huizhou, China

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Jiangmen, China

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Jiangmen, China

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Jiangsu, China

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Jiangxi, China

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Jinan, China

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Kunming, China

And 181 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (281)