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
GlaxoSmithKline
Summary
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.
Eligibility
- Age range
- 40–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 pr…
Interventions
- DrugDepemokimab
Depemokimab will be administered.
- DrugPlacebo
Matching placebo will be administered.
Locations (6)
- GSK Investigational SiteDoral, Florida
- GSK Investigational SiteChengdu
- GSK Investigational SiteGuilin
- GSK Investigational SiteJiangmen
- GSK Investigational SiteNanchang
- GSK Investigational SiteTaizhou