Study identifier:D3253C00001
ClinicalTrials.gov identifier:NCT04157348
EudraCT identifier:2019-001832-77
CTIS identifier:2023-510248-19-00
A Randomised, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in Patients Receiving Standard of Care Therapy (MANDARA Study)
Eosinophilic Granulomatous Vasculitis
Phase 3
No
-
All
140
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Benralizumab arm 1x benralizumab SC injection + 3x placebo to mepolizumab SC injections | Biological/Vaccine: Benralizumab 30 mg/mL solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) Biological/Vaccine: Placebo to Mepolizumab Matching placebo: 0.9% sodium chloride, solutions for injection in 1mL syringes (3 syringes will be used on each dosing occasion). Injection volume per syringe is 1mL. Placebo to Mepolizumban will be administered subcutaneously (SC) |
Active Comparator: Mepolizumab arm 3x mepolizumab SC injections + 1x placebo to benralizumab SC injection | Biological/Vaccine: Mepolizumab 3x100 mg vials of powder for solution for injection reconstituted into 3 separate 1 mL syringes for administration on each dosing occasion. Injection volume per syringe is 1 mL. Mepolizumab active solution will be administered subcutaneously (SC) Biological/Vaccine: Placebo to Benralizumab Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC) |