A Study of Benralizumab in Patients With Eosinophilic Esophagitis (MESSINA)
A Study of Benralizumab in Patients With Eosinophilic Esophagitis (MESSINA)
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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis
Actual Study Start Date: September 22, 2020
Estimated Primary Completion Date: July 15, 2022
Estimated Study Completion Date: March 22, 2024
Arm:
- Experimental: Benralizumab
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 170 |
| Actual Study start date | 22 September 2020 |
| Estimated Study Completion Date | 22 March 2024 |