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Benralizumab

Phase 3

Eosinophilic Granulomatous Vasculitis | Monoclonal antibody | Immunology |AstraZeneca PLC|Last Updated: May 11, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04157348Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.PHASE3 ACTIVE NOT_RECRUITING 140 — — Oct 29, 2019Nov 30, 2026May 11, 202650 United States, Belgium +7
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Study Endpoints
Primary Endpoints
Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48
Week 36 and Week 48

Percentage of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 4 mg/day (main remission definition) at both Weeks 36 and 48.

Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48
Week 36 and Week 48

Supportive endpoint: Proportion of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 7.5 mg/day (supportive remission definition) at both Weeks 36 and 48.

Secondary Endpoints
Total Accrued Duration of Remission During DB Treatment Period
from baseline to end of DB period, 52 Weeks.
Total Accrued Duration of Sustained Remission During DB Treatment Period
from baseline to end of DB period, 52 Weeks
Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse
from baseline to end of DB period, 52 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Benralizumab armEXPERIMENTAL1x benralizumab SC injection + 3x placebo to mepolizumab SC injections
Mepolizumab armACTIVE_COMPARATOR3x mepolizumab SC injections + 1x placebo to benralizumab SC injection
Interventions
NameTypeDescription
BenralizumabBIOLOGICAL30 mg/mL solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC)
MepolizumabBIOLOGICAL3x100 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)
Placebo to MepolizumabBIOLOGICALMatching 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)
Placebo to BenralizumabBIOLOGICALMatching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC)
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites50

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 polyneur...

Countries:United StatesBelgiumCanadaFranceGermanyIsraelItalyJapanUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT04157348primaryCompletionDate: changed
LOWMay 24, 2026NCT04157348studyFirstPostDate: changed