depemokimab as an extended treatment duration biologic in adults with chronic obstructive pulmonary disease (copd) and type 2 inflammation (endura-2)

Conditions: Pulmonary Disease, Chronic Obstructive

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.

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Eligibility criteria:
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 \ 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)

Keywords: depemokimab gsk3511294 eosinophilic phenotype chronic obstructive pulmonary disease copd moderate copd severe copd uncontrolled moderate to severe chronic obstructive pulmonary disease (copd) exacerbations placebo type 2 inflammation