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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2020-09-22 |
| Est. Completion | 2023-02-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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