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MESSINA


Title Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA)
Therapeutic Area Eosinophilic Esophagitis, Eosinophilic Esophagitis
Principal Investigator John Leung, MD
Min Age 12 Years
Max Age 65 Years
Gender All
Contact Selma Sinanovic
617-636-2392
ssinanovic@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04543409

Overview

This study has 3 treatment periods: A 24-week double-blind treatment period, a 28-week open-label treatment period, and an open-label extension. Subjects that complete the 52-week treatment period, double blind and open label on investigational product will be eligible to continue into a 52-week open label extension period on benralizumab 30 mg every 4 weeks (Q4W). The open label extension period is intended to allow each patient 1 year of treatment with open label benralizumab after completion of the 52-week double blind and open label treatment periods. All eligible subjects will be invited to participate in the open label extension. Patients who do not enroll in the open label extension will have a follow-up visit 12 weeks after their last dose of IP.

Study Details

Inclusion Criteria

  • Documented previous diagnosis of EoE by endoscopy (documented diagnosis defined as an esophageal count of ≥15 eos/hpf on at least 1 esophageal level) and confirmed diagnosis by a centrally-read esophageal biopsy for the purposes of this study (confirmed diagnosis defined as an esophageal count of ≥15 eos/hpf at 2 or more esophageal levels). Two to 4 biopsies should be obtained from both the proximal and distal esophagus. Biopsies can be taken from the mid-esophagus for additional evaluation.
  • Must be symptomatic at Visit 1 (run-in period) and Visit 2 (randomization):
    • A patient reported average of at least 2 days per week with an episode of dysphagia over the 4 weeks prior to the run-in period
      AND
    • At least 2 days with an episode of dysphagia (Daily DSQ ≥2) per week between Visit 1 and the Visit 2 (randomization)
  • May be on background medications for EoE and related treatments during the study as long as the background medications have been stable for at least 4 weeks prior to the run-in period and there is agreement not to change type of background medication or dosage for the first 52 weeks of the study unless medically indicated. Patients on PPI therapy must report a stable dose for at least 8 weeks prior to the run-in period.

Exclusion Criteria

  • Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation during the run-in period
  • Eosinophilic gastritis, gastroenteritis, enteritis, or colitis documented by biopsy
  • Concomitant use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, and systemic corticosteroids

Study Requirements

This study may last up to 72 weeks. There are 14 visits in the double-blind portion of the study as well as 14 visits in the open label portion of the study. There is one EKG in this study, and 4 endoscopies. There are 9 blood draw days scheduled in this study.