A Study of Benralizumab in Patients With Eosinophilic Esophagitis

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.

Timeline

Start

2020-09-22

Primary completion

2022-09-19

Completion

2023-02-06

Publications

• Rothenberg ME, Dellon ES, Collins MH, Bredenoord AJ, Hirano I, Peterson KA, Brooks L, Caldwell JM, Fjallbrant H, Grindebacke H, Ho CN, Keith M, McCrae C, Sinibaldi D, White WI, Datto CJ; MESSINA Trial Investigators. Eosinophil Depletion with Benralizumab for Eosinophilic Esophagitis. N Engl J Med. 2024 Jun 27;390(24):2252-2263. doi: 10.1056/NEJMoa2313318.

Drugs

Indications