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A Study of Benralizumab in Patients With Eosinophilic Esophagitis (MESSINA)

Primary Purpose

Eosinophilic Esophagitis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Benralizumab
Matching placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Eosinophilic Esophagitis, EoE, Benralizumab

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 12 to 65 years of age, inclusive, at the time of signing the informed consent or assent (if applicable) form.
  • Documented previous diagnosis of EoE by endoscopy.
  • Must be symptomatic at Visit 1 (screening) and Visit 2 (randomization):

    1. A patient reported an average of at least 2 days per week with an episode of dysphagia over the 4 weeks prior to Visit 1 AND
    2. An average of at least 2 days per week with an episode of dysphagia (Daily DSQ ≥2) between Visit 1 and Visit 2, and at least 2 days per week with an episode of dysphagia (Daily DSQ ≥2) in each of the 2 weeks immediately prior to 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 (8 weeks for PPI) prior to the screening and there is agreement not to change type of background medication or dosage during the run-in period and for the first 52 weeks of the study unless a change is medically indicated.
  • Negative serum pregnancy test for female patients of childbearing potential at Visit1.
  • Women of childbearing potential must agree to use a highly effective form of birth control (confirmed by the Investigator) from randomization throughout the study duration and within 12 weeks after last dose if IP.

Exclusion Criteria:

  • Other GI disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, or celiac disease.
  • Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation during the run-in period.
  • Esophageal dilation performed within 8 weeks prior to screening and prior esophageal surgery that would impact the assessments for EoE
  • Use of a feeding tube, or having a pattern of not eating solid food daily during the run-in period.
  • Hypereosinophilic syndrome, defined by multiple organ involvement and persistent blood eosinophil count >1500 eos/μL.
  • EGPA vasculitis.
  • Eosinophilic gastritis, gastroenteritis, enteritis, or colitis documented by biopsy.
  • Current malignancy, or history of malignancy with some specific exceptions.
  • History of anaphylaxis to any biologic therapy or vaccine.
  • Current active liver disease:

    • Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen [HBsAg] or hepatitis C antibody), or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria.
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 times the upper limit of normal (ULN), confirmed by repeated testing during the run-in period.
  • Helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent or assent (if applicable) is obtained that has not been treated with or has failed to respond to standard of care therapy.
  • History of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
  • Concomitant use of immunosuppressive medication.
  • Initiation or change of a food-elimination diet regimen or reintroduction of a previously eliminated food group in the 6 weeks prior to start of the run-in period.
  • Currently pregnant, breastfeeding, or lactating women.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Benralizumab

Placebo

Arm Description

Benralizumab active solution will be administered SC to patients by healthcare professionals in this clinical study using an accessorized prefilled syringe (APFS)

Placebo solution will be administered SC to patients by healthcare professionals in this clinical study using an accessorized prefilled syringe (APFS)

Outcomes

Primary Outcome Measures

Proportion of patients with a histologic response at Week 24, defined as a peak esophageal intraepithelial eosinophil count ≤ 6 eos/hpf.
Changes from baseline in Dysphagia Symptom Questionnaire (DSQ)
The Dysphagia Symptom Questionnaire (DSQ) captures the presence and severity of dysphagia symptoms in the past day in a 4-item questionnaire. The DSQ score is calculated over 14-day periods and ranges from 0 to 84, with a lower score indicating less severe dysphagia.

Secondary Outcome Measures

Percent change from baseline in tissue eosinophils
Change from baseline in Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS) grade score
EoE-HSS Grade and Stage Scores evaluate eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change).
Change from baseline in Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS) stage score
EoE-HSS Grade and Stage Scores evaluate eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change).
Changes from baseline in centrally-read Endoscopic Reference Score (EREFS)
EREFS is a scoring system for assessing the presence and severity of the major endoscopic signs of EoE.The score ranges from 0 (normal) to 9 (severe disease).
Treatment responder rate at Week 24, defined as a composite of histological response (≤6eos/hpf) and clinically meaningful improvement from baseline in Dysphagia Symptom Questionnaire (DSQ) (30% improvement)
Centrally-read biopsies for additional histopathology including tissue eosinophil counts
Histopathology findings analyzed by Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS).
Dysphagia-free days as captured by the Dysphagia Symptom Questionnaire (DSQ)
Dysphagia free days is a count ranging from 0-28. Higher counts indicate better outcomes.
Frequency of dysphagia episodes as captured by the Eosinophilic Esophagitis Daily Dysphagia Diary (EoE-3D)
EoE-3D is a daily diary focused on the patient experience of EoE. The dysphagia-associated pain, discomfort, and overall severity scores range from 0 to 10, with higher scores meaning worse outcomes.
Changes from baseline in dysphagia associated pain, discomfort, and overall severity as captured by the EoE-3D
Changes from baseline in abdominal pain and nausea as captured by the daily diary.
Changes from baseline in PEESS
The Pediatric Eosinophilic Esophagitis Symptom Severity Module, Version 2, Children and Teens Report (PEESS) is a questionnaire of EoE symptom severity and frequency in patients age 8 to 18 years.
Changes from baseline in Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EOE-QoL-A)
The Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EoE-QoL-A) is a 30-item assessment developed specifically to measure health-related quality of life in patients with EoE. The overall score ranges from 0 to 96, with higher scores meaning better quality of life.
Change from baseline in Short Form 36-item health survey (version 2, acute recall) (SF-36v2)
The Short Form 36-item Health Survey, version 2, acute recall (SF-36v2) is a 36-item, self-report survey of functional health and well-being, with a 1-week recall period. There are 8 domain scores: Physical Functioning (PF), Role Limitations due to Physical Health (RP), Bodily Pain (BP), General Health Perceptions (GH), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (RE), and Mental Health (MH). All scores range from 0-100, with higher scores meaning better outcomes.
Percent of patients with relevant concomitant procedures and healthcare resource utilization during the study through Week 24.
Patient reported overall severity of disease as measured by Patient Global Impression of Severity (PGI-S)
Patient Global Impression of Severity (PGI-S) is an assessment of the patient's perceived disease severity. The answer options are "no symptoms," "very mild," "mild," "moderate," "severe," and "very severe."
Patient reported change in health status since baseline as measured by Patient Global Impression of Change (PGI-C)
Patient Global Impression of Change (PGI-C) measures the patient's overall impression of response to treatment since the initial dose. The answer options are "much better," "moderately better," "a little better," "about the same/no change," "a little worse," "moderately worse," and "much worse."

Full Information

First Posted
August 18, 2020
Last Updated
February 20, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04543409
Brief Title
A Study of Benralizumab in Patients With Eosinophilic Esophagitis
Acronym
MESSINA
Official Title
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
High-level results from the MESSINA Phase III trial showed that AstraZeneca's Fasenra (benralizumab) did not meet one of the two dual-primary endpoints. Given the lack of clear benefit in this patient population, study has been terminated.
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
September 19, 2022 (Actual)
Study Completion Date
February 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Eosinophilic Esophagitis, EoE, Benralizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benralizumab
Arm Type
Experimental
Arm Description
Benralizumab active solution will be administered SC to patients by healthcare professionals in this clinical study using an accessorized prefilled syringe (APFS)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo solution will be administered SC to patients by healthcare professionals in this clinical study using an accessorized prefilled syringe (APFS)
Intervention Type
Biological
Intervention Name(s)
Benralizumab
Intervention Description
Solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
Intervention Type
Biological
Intervention Name(s)
Matching placebo
Intervention Description
Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC), 1 mL fill volume
Primary Outcome Measure Information:
Title
Proportion of patients with a histologic response at Week 24, defined as a peak esophageal intraepithelial eosinophil count ≤ 6 eos/hpf.
Time Frame
Week 24
Title
Changes from baseline in Dysphagia Symptom Questionnaire (DSQ)
Description
The Dysphagia Symptom Questionnaire (DSQ) captures the presence and severity of dysphagia symptoms in the past day in a 4-item questionnaire. The DSQ score is calculated over 14-day periods and ranges from 0 to 84, with a lower score indicating less severe dysphagia.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percent change from baseline in tissue eosinophils
Time Frame
Week 24
Title
Change from baseline in Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS) grade score
Description
EoE-HSS Grade and Stage Scores evaluate eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change).
Time Frame
Week 24
Title
Change from baseline in Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS) stage score
Description
EoE-HSS Grade and Stage Scores evaluate eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change).
Time Frame
Week 24
Title
Changes from baseline in centrally-read Endoscopic Reference Score (EREFS)
Description
EREFS is a scoring system for assessing the presence and severity of the major endoscopic signs of EoE.The score ranges from 0 (normal) to 9 (severe disease).
Time Frame
Week 24
Title
Treatment responder rate at Week 24, defined as a composite of histological response (≤6eos/hpf) and clinically meaningful improvement from baseline in Dysphagia Symptom Questionnaire (DSQ) (30% improvement)
Time Frame
Week 24
Title
Centrally-read biopsies for additional histopathology including tissue eosinophil counts
Description
Histopathology findings analyzed by Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS).
Time Frame
Week 24
Title
Dysphagia-free days as captured by the Dysphagia Symptom Questionnaire (DSQ)
Description
Dysphagia free days is a count ranging from 0-28. Higher counts indicate better outcomes.
Time Frame
Week 24
Title
Frequency of dysphagia episodes as captured by the Eosinophilic Esophagitis Daily Dysphagia Diary (EoE-3D)
Description
EoE-3D is a daily diary focused on the patient experience of EoE. The dysphagia-associated pain, discomfort, and overall severity scores range from 0 to 10, with higher scores meaning worse outcomes.
Time Frame
Week 24
Title
Changes from baseline in dysphagia associated pain, discomfort, and overall severity as captured by the EoE-3D
Time Frame
Week 24
Title
Changes from baseline in abdominal pain and nausea as captured by the daily diary.
Time Frame
Week 24
Title
Changes from baseline in PEESS
Description
The Pediatric Eosinophilic Esophagitis Symptom Severity Module, Version 2, Children and Teens Report (PEESS) is a questionnaire of EoE symptom severity and frequency in patients age 8 to 18 years.
Time Frame
Week 24
Title
Changes from baseline in Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EOE-QoL-A)
Description
The Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EoE-QoL-A) is a 30-item assessment developed specifically to measure health-related quality of life in patients with EoE. The overall score ranges from 0 to 96, with higher scores meaning better quality of life.
Time Frame
Week 24
Title
Change from baseline in Short Form 36-item health survey (version 2, acute recall) (SF-36v2)
Description
The Short Form 36-item Health Survey, version 2, acute recall (SF-36v2) is a 36-item, self-report survey of functional health and well-being, with a 1-week recall period. There are 8 domain scores: Physical Functioning (PF), Role Limitations due to Physical Health (RP), Bodily Pain (BP), General Health Perceptions (GH), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (RE), and Mental Health (MH). All scores range from 0-100, with higher scores meaning better outcomes.
Time Frame
Week 24
Title
Percent of patients with relevant concomitant procedures and healthcare resource utilization during the study through Week 24.
Time Frame
Week 24
Title
Patient reported overall severity of disease as measured by Patient Global Impression of Severity (PGI-S)
Description
Patient Global Impression of Severity (PGI-S) is an assessment of the patient's perceived disease severity. The answer options are "no symptoms," "very mild," "mild," "moderate," "severe," and "very severe."
Time Frame
Week 24
Title
Patient reported change in health status since baseline as measured by Patient Global Impression of Change (PGI-C)
Description
Patient Global Impression of Change (PGI-C) measures the patient's overall impression of response to treatment since the initial dose. The answer options are "much better," "moderately better," "a little better," "about the same/no change," "a little worse," "moderately worse," and "much worse."
Time Frame
Week 24
Other Pre-specified Outcome Measures:
Title
Benralizumab Pharmacokinetics
Description
Serum concentrations of benralizumab.
Time Frame
Minimum of 52 weeks
Title
Immunogenicity of benralizumab
Description
Immunogenicity of benralizumab assessed by ADA and nAb.
Time Frame
Minimum of 52 weeks
Title
Safety and tolerability
Description
- Percentage of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Minimum of 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 12 to 65 years of age, inclusive, at the time of signing the informed consent or assent (if applicable) form. Documented previous diagnosis of EoE by endoscopy. Must be symptomatic at Visit 1 (screening) and Visit 2 (randomization): A patient reported an average of at least 2 days per week with an episode of dysphagia over the 4 weeks prior to Visit 1 AND An average of at least 2 days per week with an episode of dysphagia (Daily DSQ ≥2) between Visit 1 and Visit 2, and at least 2 days per week with an episode of dysphagia (Daily DSQ ≥2) in each of the 2 weeks immediately prior to 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 (8 weeks for PPI) prior to the screening and there is agreement not to change type of background medication or dosage during the run-in period and for the first 52 weeks of the study unless a change is medically indicated. Negative serum pregnancy test for female patients of childbearing potential at Visit1. Women of childbearing potential must agree to use a highly effective form of birth control (confirmed by the Investigator) from randomization throughout the study duration and within 12 weeks after last dose if IP. Exclusion Criteria: Other GI disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, or celiac disease. Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation during the run-in period. Esophageal dilation performed within 8 weeks prior to screening and prior esophageal surgery that would impact the assessments for EoE Use of a feeding tube, or having a pattern of not eating solid food daily during the run-in period. Hypereosinophilic syndrome, defined by multiple organ involvement and persistent blood eosinophil count >1500 eos/μL. EGPA vasculitis. Eosinophilic gastritis, gastroenteritis, enteritis, or colitis documented by biopsy. Current malignancy, or history of malignancy with some specific exceptions. History of anaphylaxis to any biologic therapy or vaccine. Current active liver disease: Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen [HBsAg] or hepatitis C antibody), or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 times the upper limit of normal (ULN), confirmed by repeated testing during the run-in period. Helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent or assent (if applicable) is obtained that has not been treated with or has failed to respond to standard of care therapy. History of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test. Concomitant use of immunosuppressive medication. Initiation or change of a food-elimination diet regimen or reintroduction of a previously eliminated food group in the 6 weeks prior to start of the run-in period. Currently pregnant, breastfeeding, or lactating women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc E. Rothenberg, MD, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Research Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Research Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Research Site
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Research Site
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Research Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Research Site
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Research Site
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1G5
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1E4
Country
Canada
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 2G1
Country
Canada
Facility Name
Research Site
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Research Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Research Site
City
Lille
ZIP/Postal Code
F-59037
Country
France
Facility Name
Research Site
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Research Site
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Research Site
City
Suresnes Cedex
ZIP/Postal Code
92151
Country
France
Facility Name
Research Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Research Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Research Site
City
Remscheid
ZIP/Postal Code
42859
Country
Germany
Facility Name
Research Site
City
Afula
ZIP/Postal Code
18341
Country
Israel
Facility Name
Research Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Research Site
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Research Site
City
Petach-Tikva
ZIP/Postal Code
4920235
Country
Israel
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16126
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Research Site
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Research Site
City
Chiba
ZIP/Postal Code
260-0877
Country
Japan
Facility Name
Research Site
City
Izumo-shi
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Research Site
City
Maebashi-shi
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Research Site
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Research Site
City
Knurów
ZIP/Postal Code
44-190
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Research Site
City
Rzeszow
ZIP/Postal Code
35-302
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
50-449
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454091
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
105066
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Research Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Research Site
City
Darlington
ZIP/Postal Code
DL3 6HX
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
E1 2AJ
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3255C00001&attachmentIdentifier=ac52d6ea-ef76-4f2a-80d2-34c1df605954&fileName=947_Messina_US_Poster_(Interactive)_V2.0_Master.pdf&versionIdentifier=
Description
This is a poster.

Learn more about this trial

A Study of Benralizumab in Patients With Eosinophilic Esophagitis

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