Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

Part of paid clinical trials in Encinitas, California.

Sponsor
GlaxoSmithKline
Study ID
NCT04719832
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GSK3511294 (Depemokimab) — BIOLOGICAL
    GSK3511294 (Depemokimab) will be administered using a pre-filled syringe.
  • Placebo — DRUG
    Matching placebo will be administered as a normal saline using a pre-filled syringe.

Study Details

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) in participants with severe uncontrolled asthma with an eosinophilic phenotype

Key Dates

Start date
Mar 17, 2021
Status verified
Nov 2024
Primary completion
Nov 21, 2023
Completion
Nov 21, 2023

Study Design

Enrollment
395 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GSK3511294
    Participants received a 100 milligram (mg) dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.
  • Placebo Comparator: Placebo
    Participants received placebo subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.

Primary Outcome Measure

Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks [ Time Frame: Up to Week 52 ]

Locations (30)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteEncinitasCalifornia92024-
GSK Investigational SiteLong BeachCalifornia90806-
GSK Investigational SitePasadenaCalifornia91105-
GSK Investigational SiteRancho CucamongaCalifornia91730-
GSK Investigational SiteSan JoseCalifornia95117-
GSK Investigational SiteCoral GablesFlorida33134-
GSK Investigational SiteLoxahatchee GrovesFlorida33470-9272-
GSK Investigational SiteMiamiFlorida33125-
GSK Investigational SiteMiamiFlorida33144-
GSK Investigational SiteNew Port RicheyFlorida34655-
GSK Investigational SiteOrlandoFlorida32806-
GSK Investigational SiteAlpharettaGeorgia30022-
GSK Investigational SiteCalhounGeorgia30103-
GSK Investigational SiteColumbusGeorgia31326-
GSK Investigational SiteSavannahGeorgia31406-
GSK Investigational SiteNormalIllinois61761-
GSK Investigational SiteLexingtonKentucky40509-
GSK Investigational SiteOwensboroKentucky42301-
GSK Investigational SiteRochester HillsMichigan48507-
GSK Investigational SiteLas VegasNevada89123-
GSK Investigational SiteNew YorkNew York10036-
GSK Investigational SiteThe BronxNew York10459-2417-
GSK Investigational SiteGastoniaNorth Carolina28054-
GSK Investigational SiteClevelandOhio44106-
GSK Investigational SiteBoerneTexas78006-
GSK Investigational SiteCypressTexas77099-
GSK Investigational SiteCypressTexas77429-
GSK Investigational SiteDallasTexas75235-
GSK Investigational SiteKerrvilleTexas78028-
GSK Investigational SiteSan AntonioTexas78258-

Find similar trials in Encinitas, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
GSK Investigational Site· Encinitas, CAGSK Investigational Site· Long Beach, CAGSK Investigational Site· Pasadena, CAGSK Investigational Site· Rancho Cucamonga, CAGSK Investigational Site· San Jose, CAGSK Investigational Site· Coral Gables, FL

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