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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 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. The trial reports 20 study locations across 11 states.

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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).

Conditions Studied

Eosinophilic Granulomatous Vasculitis

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

FieldValue
Enrollment Target 140 participants
Start Date 2019-10-29
Est. Completion 2026-03-31
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04157348

The ClinicalTrials.gov registry entry for NCT04157348 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.