OCEAN
Research type
Research Study
Full title
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
IRAS ID
1005395
Contact name
Bea Tilt
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2021-005726-15
Clinicaltrials.gov Identifier
Research summary
Depemokimab is being tested as a potential new medicine for eosinophilic granulomatosis with polyangiitis (EGPA). Depemokimab is a type of medicine called a monoclonal antibody that is made in the laboratory. It works by reducing the number of eosinophils in the body. Eosinophils are white blood cells that are a normal part of the body’s immune system. However, too many eosinophils lead to inflammation, which can cause EGPA.
This research study is being done to learn more about EGPA, and if treatment with depemokimab can improve EGPA in participants. This study is also investigating how well depemokimab works to treat people with EGPA compared with mepolizumab and whether depemokimab is safe. Mepolizumab is also a monoclonal antibody that is made in the laboratory. It works by reducing eosinophils in your body and reducing inflammation (like depemokimab – described above). Mepolizumab is approved in many countries including the United Kingdom for use in patients with EGPA.
This 52-week study will randomly assign participants in a 1:1 ratio to receive either depemokimab or mepolizumab. 160 participants are planned to take part in this study at approximately 80 sites worldwide.REC name
North East - York Research Ethics Committee
REC reference
22/NE/0078
Date of REC Opinion
28 Jun 2022
REC opinion
Further Information Favourable Opinion