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NCT04543409 · ClinicalTrials.gov registry record · Phase 3

A Study of Benralizumab in Patients With Eosinophilic Esophagitis

A Phase 3 study, sponsored by AstraZeneca.

Terminated
Registry status
Phase 3
Development phase
211
Enrollment target

NCT04543409 is a Phase 3 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 211 participants.

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The verdict

NCT04543409, a Phase 3 study, was terminated before completion, sponsored by AstraZeneca.

TERMINATED
Registry status
Phase 3
Development phase
211 participants
Enrollment target

Study Summary

The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment period and a 28-week open-label treatment period). It is proposed that benralizumab will deplete eosinophils from GI tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity. Upon completion of the initial 52-week treatment period, patients will be offered an additional Open Label Extension period of at least 1 year, with benralizumab treatment and ongoing study assessments.

Interventions

  • BIOLOGICAL Benralizumab
  • BIOLOGICAL Matching placebo

Trial Details

FieldValue
Enrollment Target 211 participants
Start Date 2020-09-22
Est. Completion 2023-02-06
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT04543409

The ClinicalTrials.gov registry entry for NCT04543409 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 211 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 0 conditions, and to 2 interventions - of which Benralizumab is the first listed.

NCT04543409 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04543409 about?

NCT04543409 is a clinical study titled "A Study of Benralizumab in Patients With Eosinophilic Esophagitis". The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment perio...

What is the current status of trial NCT04543409?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2020-09-22. Estimated completion is 2023-02-06.

What interventions are being tested in trial NCT04543409?

The interventions under investigation include: Benralizumab (BIOLOGICAL), Matching placebo (BIOLOGICAL).

Who is sponsoring clinical trial NCT04543409?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.