depemokimab as an extended treatment duration biologic in adults with chronic obstructive pulmonary disease (copd) and type 2 inflammation (endura -1)

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 as an add-on medicine in participants with uncontrolled moderate to severe copd with type 2 inflammation.


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 less than (\ 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 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 exacerbations placebo type 2 inflammation