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)
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
- About 5000 people in the United States are affected by EGPA¹
- Patients with EGPA have decreased quality of life, including physical functioning, emotional role limitations, physical role limitations, social functioning, mental health, bodily pain, and vitality²
- Recurrent relapse can place the patient at increased risk of permanent tissue/organ damage secondary to vasculitis³˒⁴
1. Data on file. 2017N348628_00. 3. US Census Bureau. U.S. and world population clock. Accessed October 10, 2019; 2. Sokolowska B, et al. Clin Rheumatol. 2013;32:779-785; 3. Wechsler ME, et al. N Engl J Med. 2017;376:1921-1932; 4. Doubelt I, et al. ACR Open Rheumatol. 2021; 3(6):404-412. doi: 10.1002/acr2.11263
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.