Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 3 study, sponsored by AstraZeneca.
NCT04543409 is a Phase 3 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 211 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of patients with a histologic response at Week 24 and Week 52. A histologic response is defined as a peak esophageal intraepithelial eosinophil count \<= 6 eos/hpf across all available esophageal levels. Subjects with no biopsy data at Week 24 or with intercurrent events prior to Week 24 such as changes to background medications or additional new therapies for EoE are considered non-responders. The number analyzed represents the number of participants in the treatment group that coul
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 |
Why NCT04543409 stopped before completion
NCT04543409 is an interventional study that assigns participants to a tested intervention. The registered 211 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 (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Benralizumab is the first listed.
NCT04543409 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04543409's enrollment target sits among peer trials
211 1337th of 2000 higher than 663 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06698796 · 211 participants · Phase 3
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
- NCT04228978 · 212 participants · NA
Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss
- NCT04725721 · 212 participants · NA
Testing FIRST in Youth Outpatient Psychotherapy
- NCT06257576 · 212 participants · Phase 3
Function of Tamsulosin in Older Males Undergoing Surgery with Indwelling Catheter
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI