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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - 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 Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DRUG

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

Locations (1)

GSK Investigational Site
Orlando, Florida, United States