Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Part of paid clinical trials in Denver, Colorado.

Sponsor
GlaxoSmithKline
Study ID
NCT05263934
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Eosinophilic Granulomatosis With Polyangiitis

Eligibility Criteria

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

Interventions

  • Depemokimab — BIOLOGICAL
    Depemokimab will be administered
  • Mepolizumab — BIOLOGICAL
    Mepolizumab will be administered
  • Placebo matching mepolizumab — DRUG
    Placebo matching to mepolizumab will be administered.
  • Placebo matching depemokimab — DRUG
    Placebo matching to depemokimab will be administered.

Study Details

This study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy.

Key Dates

Start date
Jul 14, 2022
Status verified
Nov 2025
Primary completion
Sep 29, 2026
Completion
Oct 27, 2026

Study Design

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

Arms

  • Experimental: Participants receiving depemokimab+placebo matching mepolizumab
  • Active Comparator: Participants receiving mepolizumab+placebo matching depemokimab

Primary Outcome Measure

Number of participants with remission (Birmingham Vasculitis Activity Score [BVAS] =0 and a dose of oral corticosteroid [OCS] less than or equal to [<=] 4 milligram [mg] per day) [ Time Frame: Up to Week 52 ]

Locations (9)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteDenverColorado80206-
GSK Investigational SiteGainesvilleFlorida32610-
GSK Investigational SiteRochesterMinnesota55905-
GSK Investigational SiteNew YorkNew York10021-
GSK Investigational SiteCharlotteNorth Carolina28211-
GSK Investigational SiteTulsaOklahoma74136-
GSK Investigational SitePhiladelphiaPennsylvania19104-
GSK Investigational SitePittsburghPennsylvania15261-
GSK Investigational SiteNorfolkVirginia23507-

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