eosinophilic granulomatosis with polyangiitis(EGPA)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1)Male or female subjects aged >=18 years at the time the informed consent form is signed (2)Diagnosis of EGPA (3)Subjects receive background OGC dose of>=7.5 mg/day with or without stable treatment with mepolizumab or benralizumab.
Exclusion criteria
Exclusion criteria: (1) Current diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis (2) Imminently life-threatening EGPA disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects in remission (oral glucocorticoid [OGC] 4.0)* at Week 28 of the study treatment period. *Definition of remission (OGC 4.0): Birmingham Vasculitis Activity Score (BVAS) of 0 AND OGC dose of prednisolone/prednisone <=4.0 mg/day. | — |
Countries
Canada, France, Germany, Italy, Japan, Spain, UK, US
Contacts
Nippon Shinyaku Co., Ltd.