A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

Part of paid clinical trials in Alabaster, Alabama.

Sponsor
GlaxoSmithKline
Study ID
NCT04718103
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • GSK3511294 — BIOLOGICAL
    GSK3511294 was administered using a pre-filled syringe.
  • Placebo — BIOLOGICAL
    Placebo was administered as normal saline using a pre-filled syringe.

Study Details

This study will assess the efficacy and safety of GSK3511294 (Depemokimab) as an adjunctive therapy in participants with severe uncontrolled asthma with an eosinophilic phenotype.

Key Dates

Start date
Feb 4, 2021
Status verified
Nov 2024
Primary completion
Apr 11, 2024
Completion
Apr 11, 2024

Study Design

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

Arms

  • Experimental: GSK3511294
    Participants received a 100 milligram (mg) dose of GSK3511294 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.
  • Placebo Comparator: Placebo
    Participants received placebo 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.

Primary Outcome Measure

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

Locations (41)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteAlabasterAlabama35007-
GSK Investigational SiteMobileAlabama36608-
GSK Investigational SitePhoenixArizona85032-
GSK Investigational SiteBeverly HillsCalifornia90048-
GSK Investigational SiteLancasterCalifornia93534-
GSK Investigational SiteColorado SpringsColorado80923-
GSK Investigational SiteLafayetteColorado80026-
GSK Investigational SiteAventuraFlorida33180-
GSK Investigational SiteHialeahFlorida33014-
GSK Investigational SiteMiamiFlorida33144-
GSK Investigational SiteMiamiFlorida33186-
GSK Investigational SiteMiami LakesFlorida33014-
GSK Investigational SiteOrlandoFlorida32803-
GSK Investigational SiteAtlantaGeorgia30281-
GSK Investigational SiteEvanstonIllinois60026-
GSK Investigational SiteColumbiaMaryland21044-
GSK Investigational SiteDearbornMichigan48124-
GSK Investigational SiteYpsilantiMichigan48197-
GSK Investigational SiteSt LouisMissouri63110-
GSK Investigational SiteNorthfieldNew Jersey08225-
GSK Investigational SiteToms RiverNew Jersey08755-
GSK Investigational SiteThe BronxNew York10467-
GSK Investigational SiteHuntersvilleNorth Carolina28078-
GSK Investigational SiteWinston-SalemNorth Carolina27103-
GSK Investigational SiteCincinnatiOhio45229-
GSK Investigational SiteCincinnatiOhio45231-
GSK Investigational SiteEdmondOklahoma73034-
GSK Investigational SiteAltoonaPennsylvania16601-
GSK Investigational SiteDuBoisPennsylvania15801-
GSK Investigational SiteHersheyPennsylvania17033-
GSK Investigational SitePhiladelphiaPennsylvania19140-
GSK Investigational SiteRapid CitySouth Dakota57702-
GSK Investigational SiteAllenTexas75013-
GSK Investigational SiteBoerneTexas78006-
GSK Investigational SiteDallasTexas75225-
GSK Investigational SiteHoustonTexas77084-
GSK Investigational SiteSan AntonioTexas78207-
GSK Investigational SiteSan AntonioTexas78229-
GSK Investigational SiteSan AntonioTexas78258-
GSK Investigational SiteBellinghamWashington98225-
GSK Investigational SiteMilwaukeeWisconsin53226-

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