Full name

A 52-week, Randomized, Double-blind, Double-dummy, Parallel-group, Multi-centre, Non-inferiority Study to Investigate the Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) Receiving Standard of Care (SoC) Therapy (OCEAN)

NCT Number
NCT05263934
Primary Endpoints

Primary:

  • 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). Up to Week 52

Secondary:

  • Number of participants in each category of accrued duration of remission. Up to Week 52
  • Number of participants with total accrued duration of remission. Up to Week 52
  • Time to first EGPA relapse. Up to Week 52
  • Number of participants receiving in each category of mean OCS dose during the last 4 weeks of study treatment period (Weeks 49 to 52)
  • Number of participants achieving remission (BVAS = 0 and OCS ≤4mg/day) within the first 24 weeks with continued remission until Week 52
  • Number of participants achieving remission using the European League against Rheumatism (EULAR) definition (BVAS = 0 and OCS ≤7.5 mg/day) at Weeks 36 and 52
  • Number of participants in each category of accrued duration of remission according to the EULAR definition of remission (BVAS = 0 plus OCS ≤7.5 mg/day) over 52-week intervention period
  • Number of participants with total accrued duration of remission according to the EULAR definition of remission. Up to Week 52
  • Number of participants with remission (BVAS=0 and OCS ≤7.5 mg/day) within the first 24 weeks with continued remission until Week 52
External Link
https://clinicaltrials.gov/study/NCT05263934
Order
1
Disease
EGPA
Menu title
OCEAN: Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Version
ACR 2025
Phase
3
Status
Recruiting
Compound name
Depemokimab
MoA
Anti-IL5 mAb
Unmet Burden Fact
  • In a phase 3 clinical study, patients in the placebo group, 81%, did not achieve remission in a 52 week period¹
  • Recurrent relapses increases risk of organ damage²
Unmet Burden Fact Reference

1. Doubelt T, et. Poster presented at ACR 2019 [abstract 2639]; 2. Wechsler ME, et al. N Engl J Med 2017;376:1921-32

Study Description

The OCEAN Study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving Standard of Care (SoC) therapy.