Efficacy and Safety of Benralizumab in EGPA compared to mepolizumab. - MANDARA

Study identifier:D3253C00001

ClinicalTrials.gov identifier:NCT04157348

EudraCT identifier:2019-001832-77

CTIS identifier:2023-510248-19-00

Recruitment Complete

Official Title

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)

Medical condition

Eosinophilic Granulomatous Vasculitis

Phase

Phase 3

Healthy volunteers

No

Study drug

-

Sex

All

Actual Enrollment

140

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 29 Oct 2019
Primary Completion Date: 10 Aug 2023
Estimated Study Completion Date: 31 Mar 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria