A Study of Benralizumab in Eosinophilic Esophagitis (MESSINA)

• Research type

  Research Study

• Full title

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

• IRAS ID

  274031

• Contact name

  Anna Tinnerberg

• Contact email

  anna.tinnerberg@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2019-002871-32

• Duration of Study in the UK

  3 years, 3 months, 18 days

• Research summary

  Summary of Research

  Benralizumab is a humanized, afucosylated, monoclonal antibody (mAb) that binds\nspecifically to the human interleukin-5 (IL-5) receptor alpha subunit (IL-5Rα) on the target cell and directly depletes eosinophils through antibody-dependent cell-mediated cytotoxicity (ADCC). It is proposed that benralizumab will deplete eosinophils from gastrointestinal tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity.\n\nThe aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. This study will compare the efficacy and safety of repeat dosing of benralizumab versus placebo in male and female patients 12 to 65 years of age with symptomatic and histologically active EoE.\n\nThe clinical study consists of 4 periods:\n a 2- to 8-week run-in period\n a 24-week placebo-controlled, double blind, parallel-group treatment period (DB period)\n a 28-week Open Label benralizumab treatment period (OL period)\n an additional Open Label Extension treatment period (OLE).\n\nApproximately 170 eligible patients are planned to be randomized. Of these, about 15 to 20 adolescent patients (12 to 17 years of age) per arm are expected to berandomized.\n\nDuring the run-in period of 2 to 8 weeks eligibility criteria are assessed, medical history taken,endoscopy with biopsies performed, and questionnaires completed. Patients should remain on a stabilized diet for at least 6 weeks prior to the run-in period and have stable background medications for at least 4 weeks prior to the run-in period and through the first 52 weeks of the study, unless medically indicated.\n\nEligible patients will receive either benralizumab or placebo every 4 weeks for 24 weeks(DB period). \n\nPatients who complete the DB period on investigational product will continue into an open-label treatment period with benralizumab until Week 52 (OL period).\n\nPatients who complete the OL will be eligible to continue into a 52-week open-label extension period on benralizumab.

  Summary of Results

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• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  19/EE/0380

• Date of REC Opinion

  24 Feb 2020

• REC opinion

  Favourable Opinion