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 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 less than (\<) 0.70 and a post- bronchodilator FEV1 \>30 percent (%) and \<= 80…
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 (15)
- GSK Investigational SiteLoxahatchee Groves, Florida
- GSK Investigational SiteMiami, Florida
- GSK Investigational SiteRock Hill, South Carolina
- GSK Investigational SiteCorsicana, Texas
- GSK Investigational SiteChangsha, Hunan
- GSK Investigational SiteChengdu, Sichuan