Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps

Part of paid clinical trials in Tucson, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT05274750
Phase
PHASE3
Status
Completed

Conditions

  • Nasal Polyps

Eligibility Criteria

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

Interventions

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

Study Details

This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).

Key Dates

Start date
Apr 22, 2022
Status verified
Nov 2025
Primary completion
Jul 30, 2024
Completion
Aug 27, 2024

Study Design

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

Arms

  • Experimental: Depemokimab
    Participants received a 100 milligram (mg) dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52 weeks. Participants were to be maintained on their existing baseline maintenance for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) 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) over a treatment period of 52 weeks. Participants were to be maintained on their existing baseline maintenance for CRSwNP SOC treatment throughout the study.

Primary Outcome Measure

Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read) [ Time Frame: Baseline (Day 1) and at Week 52 ]

Locations (26)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteTucsonArizona85704-
GSK Investigational SiteBuena ParkCalifornia90621-
GSK Investigational SiteLos AngelesCalifornia90006-
GSK Investigational SiteSan DiegoCalifornia91942-
GSK Investigational SiteStanfordCalifornia94304-
GSK Investigational SiteTemeculaCalifornia92592-
GSK Investigational SiteAuroraColorado80045-
GSK Investigational SiteGainesvilleFlorida32605-
GSK Investigational SiteTamaracFlorida33321-
GSK Investigational SiteTampaFlorida33613-
GSK Investigational SiteMeridianIdaho83642-
GSK Investigational SiteMeridianIdaho83706-
GSK Investigational SiteChicagoIllinois60612-
GSK Investigational SiteLexingtonKentucky40509-
GSK Investigational SiteLouisvilleKentucky40205-
GSK Investigational SiteBostonMassachusetts02135-
GSK Investigational SiteNew BrunswickNew Jersey08901-
GSK Investigational SiteGreat NeckNew York11021-
GSK Investigational SiteRochesterNew York14642-
GSK Investigational SiteChapel HillNorth Carolina27599-
GSK Investigational SiteCincinnatiOhio45267-
GSK Investigational SiteTulsaOklahoma74137-
GSK Investigational SiteBethlehemPennsylvania18017-
GSK Investigational SiteProvidenceRhode Island02914-
GSK Investigational SiteDallasTexas75390-9035-
GSK Investigational SiteRichmondVirginia23235-

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GSK Investigational Site· Tucson, AZGSK Investigational Site· Buena Park, CAGSK Investigational Site· Los Angeles, CAGSK Investigational Site· San Diego, CAGSK Investigational Site· Stanford, CAGSK Investigational Site· Temecula, CA

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