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Monoclonal Antibodies

Benralizumab for Eosinophilic Esophagitis (MESSINA Trial)

Phase 3
Waitlist Available
Led By Marc E. Rothenberg, MD, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24, week 52
Awards & highlights

MESSINA Trial Summary

This trial is testing whether benralizumab, which depletes eosinophils from the body, can improve symptoms and endoscopy scores in people with EoE, a disorder characterized by too many eosinophils in the tissues.

Eligible Conditions
  • Eosinophilic Esophagitis

MESSINA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24, week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24, week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes From Baseline in Dysphagia Symptom Questionnaire (DSQ)
Percentage of Patients With a Histologic Response, Defined as a Peak Esophageal Intraepithelial Eosinophil Count ≤ 6 Eos/Hpf.
Secondary outcome measures
Centrally-read Biopsies for Additional Histopathology Including Tissue Eosinophil Counts at Week 24
Change From Baseline in Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS) Total Grade Score at Week 24
Change From Baseline in Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS) Total Stage Score at Week 24
+19 more
Other outcome measures
Benralizumab Pharmacokinetics
Immunogenicity of Benralizumab in Double Blind + Open Label Periods
Immunogenicity of Benralizumab in Double Blind Period
+2 more

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255
16%
Nasopharyngitis
11%
Bronchitis
8%
Headache
8%
Rhinitis
7%
Upper respiratory tract infection
5%
Sinusitis
4%
Hypertension
4%
Vertigo
3%
Back pain
3%
Pneumonia
1%
Asthma
1%
Cough
1%
Dyspnoea
1%
Cardiac failure acute
1%
Atrial fibrillation
1%
Presyncope
1%
Influenza
1%
Oesophagitis
1%
Gallbladder polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.8 Weeks
Benra 30 mg q.4 Weeks
Placebo

MESSINA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BenralizumabExperimental Treatment1 Intervention
Benralizumab active solution will be administered SC to patients by healthcare professionals in this clinical study using an accessorized prefilled syringe (APFS)
Group II: PlaceboPlacebo Group1 Intervention
Placebo solution will be administered SC to patients by healthcare professionals in this clinical study using an accessorized prefilled syringe (APFS)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 3
~10580

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,605,071 Total Patients Enrolled
5 Trials studying Eosinophilic Esophagitis
474 Patients Enrolled for Eosinophilic Esophagitis
Marc E. Rothenberg, MD, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
2 Previous Clinical Trials
46 Total Patients Enrolled
2 Trials studying Eosinophilic Esophagitis
46 Patients Enrolled for Eosinophilic Esophagitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there many places within the state where this experiment is being conducted?

"To limit participant discomfort, this trial is only recruiting from locations that are close to 24 major metropolitan areas. For example, patients near Chesterfield, Saint Petersburg and Chicago are eligible."

Answered by AI

Are there any slots left for participants in this experiment?

"Presently, this clinical trial is not enrolling new patients. The trial was first posted on 9/22/2020, and was most recently edited on 10/6/2022. If you are seeking other studies, 49 trials for eosinophilic esophagitis and 20 trials for Benralizumab are actively enrolling participants."

Answered by AI

What is the total number of participants that will be included in this clinical trial?

"Eosinophilic esophagitis clinical trials are not recruiting at this moment. The last update for this study was on October 6th, 2020. However, there are 20 other Benralizumab studies and 49 other Eosinophilic esophagitis studies that are recruiting patients."

Answered by AI

Are there similar drugs to Benralizumab that have undergone clinical trials?

"Currently, 20 separate clinical trials are investigating the efficacy of Benralizumab. 10 of these studies have reached Phase 3. Furthermore, there are 1481 research sites conducting these trials, with several located in Bethesda, Maryland."

Answered by AI

To your knowledge, is this research project unique in any way?

"There are 20 ongoing clinical trials for Benralizumab in 352 cities across 42 countries. The first trial for this drug was sponsored by AstraZeneca in 2014. This initial trial involved 20 patients and completed both its Phase 2 and 3 stages. In the 6 years since 2014, 85 more trials have been completed."

Answered by AI

What sort of risks does Benralizumab pose to patients?

"Benralizumab is estimated to be a safe medication according to our team at Power. This is because it is a Phase 3 trial, meaning that not only is there some data supporting its efficacy, but there are also multiple rounds of data supporting its safety."

Answered by AI

Are people of an older age group eligible to participate in this research project?

"According to the inclusion criteria for this study, eligible participants must be between 12 and 65 years old. There are 30 clinical trials for people under 18 and 54 for people over 65."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
Ontario
New York
How old are they?
< 18
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Benralizumab in Patients With Eosinophilic Esophagitis
2020. "A Study of Benralizumab in Patients With Eosinophilic Esophagitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04543409.
~47 spots leftby Apr 2025
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