Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT05281523
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 18, 2022
Status verified
Aug 2025
Primary completion
Jul 12, 2024
Completion
Aug 6, 2024

Study Design

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

Arms

  • Experimental: Depemokimab
    Participants received a 100 milligram (mg) dose of depemokimab subcutaneous (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 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 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 (14)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteTucsonArizona85724-
GSK Investigational SiteRosevilleCalifornia95661-
GSK Investigational SiteNew HavenConnecticut06520-
GSK Investigational SiteHialeahFlorida33012-
GSK Investigational SiteBaltimoreMaryland21287-
GSK Investigational SiteGrand RapidsMichigan55446-
GSK Investigational SiteColumbiaMissouri65212-
GSK Investigational SiteOklahoma CityOklahoma73120-
GSK Investigational SiteFort WorthTexas76109-
GSK Investigational SiteMcAllenTexas78503-
GSK Investigational SiteMcKinneyTexas75070-
GSK Investigational SiteSan AntonioTexas78258-
GSK Investigational SiteNorfolkVirginia23507-
GSK Investigational SiteMorgantownWest Virginia26506-9200-

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