RECRUITING · INTERVENTIONAL · TREATMENT study · Chronic Obstructive Pulmonary Disease · Phase 3 · Enrollment 942 · Sponsor: Sanofi
Official title: A Phase 2b/Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
Summary: This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
Conditions: Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Primary purpose: TREATMENT
Phases: PHASE3
Enrollment: 942 (ESTIMATED)
Status: RECRUITING
Completion: 2030-01-22 (ESTIMATED)