Eosinophilic Granulomatous Vasculitis
Conditions
Interventions
investigational material(s)
Generic name etc : Biological: Benralizumab, Biological: Placebo to Mepolizumab
INN of investigational material : -
Therapeutic category code : 449 Other antiallergic a
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects age 18 years or older. 2. EGPA diagnosis based on history or presence asthma and eosinophilia (>1.0x10^9/L and/or >10% of leucocytes) and at least 2 of; biopsy with eosinophilic vasculitis or perivascular/granulomatous inflammation; mono-or polyneuropathy, non-fixed pulmonary infiltrates, sino-nasal abnormality; cardiomyopathy; glomerulonephritis; alveolar haemorrhage; palpable purpura; anti neutrophil cytoplasmic anti-body (ANCA) positivity (Myeloperoxidase or proteinease 3). 3. History of relapsing (at least 1 confirmed EGPA relapse within last 2 years and > 12 weeks prior to screening, or refractory (failure to attain remission, defined as BVAS=0 and oral corticosteroid (OCS) dose 50mg/day) for at least 4 weeks prior to randomization. 5. If receiving immunosuppressive therapy (excluding cyclophosphamide) the dose must be stable for the 4 weeks prior to randomization and during the study (dose reductions for safety reasons will be permitted). 6. QTc(F)<450 msec or QTc(F)<480 msec for patients with bundle branch block. 7. Females of childbearing potential must use an acceptable method of birth control from randomization for at least 12 weeks after the last study drug administration.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). 2. Organ or life-threatening EGPA 5 years ago, or >1 year ago for basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix. 5. An untreated or refractory helminth parasitic infection < 24 weeks prior to screening. 6. Unstable liver disease. 7. Severe or clinically significant, uncontrolled cardiovascular disease. 8. Other concurrent disease that may put the patient at risk, or may influence the results of the study, or the patients' ability to complete entire duration of the study. 9. Chronic or ongoing infectious disease requiring systemic treatment. 10. Known immunodeficiency disorder or positive HIV test. 11. Prior receipt of mepolizumab, reslizumab, dupilumab or benralizumab. Receipt of intravenous/intramuscular/subcutaneous corticosteroids within 4 weeks prior to randomization, receipt of omalizumab within 130 days prior to screening, rituximab within 6 months prior to screening (or B-cells not recovered), interferon-alpha or alemtuzumab within 6 months prior to screening, receipt of anti-tumor necrosis factor therapy within 12 weeks prior to screening or an investigational non-biologic product within 30 days or 5 half-lives prior to screening, whichever is longer. Receipt of any other marketed or investigational biologic products within 4 months or 5 half-lives prior to screening, whichever is longer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory pharmacokinetics - | — |
Countries
Belgium, Canada, France, Germany, Israel, Italy, United Kingdom, United States of Amerika
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed