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NCT04157348 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
A Phase 3 study of Eosinophilic Granulomatous Vasculitis, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
- 20
- Study locations
NCT04157348: Active Phase 3 study of Eosinophilic Granulomatous Vasculitis, sponsored by AstraZeneca.
NCT04157348 is a Phase 3 study of Eosinophilic Granulomatous Vasculitis that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 140 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04157348, a Phase 3 study of Eosinophilic Granulomatous Vasculitis, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC (earlier enrolled patients may therefore be in the OLE for longer than 1 year).
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Benralizumab
- BIOLOGICAL Mepolizumab
- BIOLOGICAL Placebo to Mepolizumab
- BIOLOGICAL Placebo to Benralizumab
Study Locations (20)
Other
- Research Site - Brussels
- Research Site - Brussels
- Research Site - Dijon
- Research Site - Marseille
- Research Site - Montpellier
- Research Site - Nantes
- Research Site - Paris
Ontario
- Research Site - Hamilton
- Research Site - Toronto
- Research Site - Toronto
New York
- Research Site - Great Neck
- Research Site - New York
Colorado
- Research Site - Denver
Michigan
- Research Site - Ann Arbor
Minnesota
- Research Site - Rochester
New Mexico
- Research Site - Albuquerque
Pennsylvania
- Research Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2019-10-29 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 3 |
What the registry record for NCT04157348 still lists
NCT04157348 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Eosinophilic Granulomatous Vasculitis appearing as the primary indexed condition, and to 4 interventions - of which Benralizumab is the first listed.
NCT04157348 names 20 study sites across 11 states, led by Other, Ontario, New York.
Frequently Asked Questions
What is clinical trial NCT04157348 about?
NCT04157348 is a clinical study titled "Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.". This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection in patients with relapsing or refractory EGPA on corticosteroid ther...
What is the current status of trial NCT04157348?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2019-10-29. Estimated completion is 2026-03-31.
What conditions does trial NCT04157348 study?
This clinical trial studies the following conditions: Eosinophilic Granulomatous Vasculitis.
What interventions are being tested in trial NCT04157348?
The interventions under investigation include: Benralizumab (BIOLOGICAL), Mepolizumab (BIOLOGICAL), Placebo to Mepolizumab (BIOLOGICAL), Placebo to Benralizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04157348?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04157348 being conducted?
This trial has 20 study locations across Colorado, Michigan, Minnesota, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04157348's enrollment target sits among peer trials
140 1566th of 2000 higher than 424 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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