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
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.
• 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)