NCT04543409

A Study of Benralizumab in Patients With Eosinophilic Esophagitis

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-09-22
• Primary completion: 2022-09-19
• Completion: 2023-02-06
• First posted: 2020-09-10
• Last updated: 2023-11-18
• Results posted: 2023-11-18

Locations

78 sites across 12 countries: United States, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Russia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study