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A Study of Benralizumab in Patients With Eosinophilic Esophagitis

NCT04543409 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2023-11-18

Study results available
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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.

Conditions

  • Eosinophilic Esophagitis

Interventions

BIOLOGICAL

Benralizumab

Solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume

BIOLOGICAL

Matching placebo

Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC), 1 mL fill volume

Sponsors & Collaborators

Principal Investigators

  • Marc E. Rothenberg, MD, PhD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2022-09-19
Completion
2023-02-06
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04543409 on ClinicalTrials.gov