A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab in Adult Participants With COPD With Type 2 Inflammation
GlaxoSmithKline
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.
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- No
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 \< 0.70 and a post-bronchodilator FEV1 \>30 percent (%) and \<= 80% predict…
Interventions
- DrugDepemokimab
Depemokimab as a sterile liquid formulation will be administered.
- DrugPlacebo
Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered
Locations (159)
- GSK Investigational SiteSheffield, Alabama
- GSK Investigational SiteAurora, Colorado
- GSK Investigational SiteBrooksville, Florida
- GSK Investigational SiteDoral, Florida
- GSK Investigational SiteFort Lauderdale, Florida
- GSK Investigational SiteMiami, Florida