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

Recruitment Status:
Recruiting

Sponsor:
AstraZeneca

Information Provided by (Responsible Party):
AstraZeneca

ClinicalTrials.gov Identifier:
NCT04543409

Verification:
Verified 01 April 2021   by AstraZeneca

History of Changes:
ClinicalTrials.gov

Purpose

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.

Official Title:A Multicenter, Randomized, Double-blind, Parallel-group, Placebo controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis
Study Type:Interventional
Overall Recruitment Status:Recruiting
Study Start Date:22 September 2020
Study Start Date Type:Actual
Primary Completion Date:15 July 2022
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
ConditionInterventionPhase
Eosinophilic Esophagitis
Biological/Vaccine: Benralizumab
Biological/Vaccine: Matching placebo
Phase 3
Ages Eligible for Study: 12 Years  to 65 Years
Genders Eligible for Study: Both
Gender Based: No
Accepts Healthy Volunteers: No
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 average of at least 2 days per week with an episode of dysphagia over the 4 weeks prior to the Visit 1

-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.


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    information.center@astrazeneca.com  

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Marc  E.  Rothenberg , MD, PhD   Cincinnati Children’s Hospital Medical Center

Locations

CountryLocationFacilityContactStatus
Canada , ONResearch Site London, ON, Canada, N6A 5W9Not Yet Recruiting
Canada , ONResearch Site Ottawa, ON, Canada, K1G 6C6Not Yet Recruiting
Canada , ONResearch Site Windsor, ON, Canada, N8X 2G1Recruiting
GermanyResearch Site Berlin, Germany, 10825Not Yet Recruiting
GermanyResearch Site Frankfurt, Germany, 60590Recruiting
GermanyResearch Site München, Germany, 81675Recruiting
GermanyResearch Site München, Germany, 80337Recruiting
United States of America , NCResearch Site Chapel Hill, NC, United States of America, 27514Recruiting
United States of America , NCResearch Site Winston-Salem, NC, United States of America, 27157Recruiting
United States of America , GAResearch Site Atlanta, GA, United States of America, 30322-1013Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02111Not Yet Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02115Not Yet Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02115Withdrawn
United States of America , PAResearch Site Philadelphia, PA, United States of America, 19104Recruiting
United States of America , PAResearch Site Uniontown, PA, United States of America, 15401Not Yet Recruiting
United KingdomResearch Site Brighton, United Kingdom, BN2 5BENot Yet Recruiting
United KingdomResearch Site Darlington, United Kingdom, DL3 6HXNot Yet Recruiting
United KingdomResearch Site London, United Kingdom, E1 2AJRecruiting
United KingdomResearch Site London, United Kingdom, SW17 0RENot Yet Recruiting
SpainResearch Site Badalona, Spain, 08916Recruiting
SpainResearch Site Barcelona, Spain, 08035Recruiting
SpainResearch Site Barcelona, Spain, 08036Recruiting
SpainResearch Site Bilbao (Vizcaya), Spain, 48013Recruiting
SpainResearch Site Madrid, Spain, 28031Recruiting
SpainResearch Site Madrid, Spain, 28006Recruiting
SpainResearch Site Madrid, Spain, 28040Recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60611Not yet recruiting
United States of America , ILResearch Site Normal, IL, United States of America, 61761Recruiting
United States of America , ILResearch Site Park Ridge, IL, United States of America, 60068Recruiting
United States of America , NJResearch Site Ocean, NJ, United States of America, 07712Recruiting
United States of America , CAResearch Site Orange, CA, United States of America, 92868Not yet recruiting
Canada , NSResearch Site Dartmouth, NS, Canada, B2W 6L4Not Yet Recruiting
United States of America , MDResearch Site White Marsh, MD, United States of America, 21162Recruiting
United States of America , OHResearch Site Cincinnati, OH, United States of America, 45229Recruiting
United States of America , FLResearch Site St. Petersburg, FL, United States of America, 33709Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10029Recruiting
United States of America , UTResearch Site Murray, UT, United States of America, 84107Recruiting
United States of America , UTResearch Site Salt Lake City, UT, United States of America, 84132Not yet recruiting
NetherlandsResearch Site Amsterdam, Netherlands, 1105 AZRecruiting
NetherlandsResearch Site NIEUWEGEIN, Netherlands, 3435 CMRecruiting
NetherlandsResearch Site Nijmegen, Netherlands, 6525 GARecruiting
IsraelResearch Site AFULA, Israel, Recruiting
IsraelResearch Site Haifa, Israel, 34362Withdrawn
IsraelResearch Site Holon, Israel, 58100Recruiting
IsraelResearch Site Jerusalem, Israel, 91120Not Yet Recruiting
IsraelResearch Site Kfar-Saba, Israel, 4428164Recruiting
IsraelResearch Site Petach-Tikva, Israel, 4920235Recruiting
IsraelResearch Site Tel Aviv, Israel, 64239Recruiting
ItalyResearch Site Firenze, Italy, 50134Not Yet Recruiting
ItalyResearch Site Genova, Italy, 16132Not Yet Recruiting
ItalyResearch Site NAPOLI, Italy, 80131Recruiting
ItalyResearch Site PISA, Italy, 56124Not Yet Recruiting
ItalyResearch Site ROZZANO, Italy, 20089Recruiting
ItalyResearch Site Verona, Italy, 37126Recruiting
United States of America , MNResearch Site Rochester, MN, United States of America, 55905Recruiting
FranceResearch Site Dijon Cedex, France, 21079Recruiting
FranceResearch Site Lille, France, F-59037Recruiting
FranceResearch Site LILLE CEDEX, France, 59037Recruiting
FranceResearch Site LYON CEDEX 03, France, 69437Recruiting
FranceResearch Site Pierre benite, France, 69495Withdrawn
FranceResearch Site SURESNES CEDEX, France, 92151Recruiting
FranceResearch Site Toulouse Cedex 9, France, 31059Recruiting
United States of America , ARResearch Site Little Rock, AR, United States of America, 72202Recruiting
Russian FederationResearch Site Chelyabinsk, Russian Federation, 454091Recruiting
Russian FederationResearch Site Moscow, Russian Federation, 119992Recruiting
Russian FederationResearch Site Moscow, Russian Federation, 105066Withdrawn
Russian FederationResearch Site Moscow, Russian Federation, 111123Recruiting
Russian FederationResearch Site Omsk, Russian Federation, 644112Not Yet Recruiting
PolandResearch Site Gdańsk, Poland, 80-214Not Yet Recruiting
PolandResearch Site Knurów, Poland, 44-190Recruiting
PolandResearch Site Łódź, Poland, 93-338Recruiting
PolandResearch Site Lublin, Poland, 20-582Recruiting
PolandResearch Site Rzeszow, Poland, 35-302Recruiting
PolandResearch Site Szczecin, Poland, 71-434Recruiting
PolandResearch Site Warszawa, Poland, 04-141Recruiting
PolandResearch Site Warszawa, Poland, 02-507Recruiting
PolandResearch Site Wrocław, Poland, 50-449Not Yet Recruiting
JapanResearch Site Chiba-shi, Japan, 260-8677Recruiting
JapanResearch Site Izumo-shi, Japan, 693-8501Recruiting
JapanResearch Site Maebashi-shi, Japan, 371-8511Recruiting
JapanResearch Site Osaka, Japan, 637086Recruiting
United States of America , TXResearch Site Dallas, TX, United States of America, 75246Not Yet Recruiting
United States of America , TXResearch Site Garland, TX, United States of America, 75044Not Yet Recruiting
United States of America , NEResearch Site Lincoln, NE, United States of America, 68503Recruiting
United States of America , SCResearch Site Summerville, SC, United States of America, 29486Not Yet Recruiting
United States of America , VAResearch Site Richmond, VA, United States of America, 23219Not Yet Recruiting
United States of America , ALResearch Site Birmingham, AL, United States of America, 35213Not Yet Recruiting
United States of America , MIResearch Site Chesterfield, MI, United States of America, 48047Not Yet Recruiting
Canada , OntarioResearch Site Hamilton, Ontario, Canada, L8S 1G5Not Yet Recruiting

No attachments posted.

.

Purpose

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.

Official Title:A Multicenter, Randomized, Double-blind, Parallel-group, Placebo controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis
Study Type:Interventional
Overall Recruitment Status:Recruiting
Study Start Date:22 September 2020
Study Start Date Type:Actual
Primary Completion Date:15 July 2022
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
ConditionInterventionPhase
Eosinophilic Esophagitis
Biological/Vaccine: Benralizumab
Biological/Vaccine: Matching placebo
Phase 3
Ages Eligible for Study: 12 Years  to 65 Years
Genders Eligible for Study: Both
Gender Based: No
Accepts Healthy Volunteers: No
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 average of at least 2 days per week with an episode of dysphagia over the 4 weeks prior to the Visit 1

-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.


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    information.center@astrazeneca.com  

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Marc  E.  Rothenberg , MD, PhD   Cincinnati Children’s Hospital Medical Center

Locations

CountryLocationFacilityContactStatus
Canada , ONResearch Site London, ON, Canada, N6A 5W9Not Yet Recruiting
Canada , ONResearch Site Ottawa, ON, Canada, K1G 6C6Not Yet Recruiting
Canada , ONResearch Site Windsor, ON, Canada, N8X 2G1Recruiting
GermanyResearch Site Berlin, Germany, 10825Not Yet Recruiting
GermanyResearch Site Frankfurt, Germany, 60590Recruiting
GermanyResearch Site München, Germany, 81675Recruiting
GermanyResearch Site München, Germany, 80337Recruiting
United States of America , NCResearch Site Chapel Hill, NC, United States of America, 27514Recruiting
United States of America , NCResearch Site Winston-Salem, NC, United States of America, 27157Recruiting
United States of America , GAResearch Site Atlanta, GA, United States of America, 30322-1013Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02111Not Yet Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02115Not Yet Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02115Withdrawn
United States of America , PAResearch Site Philadelphia, PA, United States of America, 19104Recruiting
United States of America , PAResearch Site Uniontown, PA, United States of America, 15401Not Yet Recruiting
United KingdomResearch Site Brighton, United Kingdom, BN2 5BENot Yet Recruiting
United KingdomResearch Site Darlington, United Kingdom, DL3 6HXNot Yet Recruiting
United KingdomResearch Site London, United Kingdom, E1 2AJRecruiting
United KingdomResearch Site London, United Kingdom, SW17 0RENot Yet Recruiting
SpainResearch Site Badalona, Spain, 08916Recruiting
SpainResearch Site Barcelona, Spain, 08035Recruiting
SpainResearch Site Barcelona, Spain, 08036Recruiting
SpainResearch Site Bilbao (Vizcaya), Spain, 48013Recruiting
SpainResearch Site Madrid, Spain, 28031Recruiting
SpainResearch Site Madrid, Spain, 28006Recruiting
SpainResearch Site Madrid, Spain, 28040Recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60611Not yet recruiting
United States of America , ILResearch Site Normal, IL, United States of America, 61761Recruiting
United States of America , ILResearch Site Park Ridge, IL, United States of America, 60068Recruiting
United States of America , NJResearch Site Ocean, NJ, United States of America, 07712Recruiting
United States of America , CAResearch Site Orange, CA, United States of America, 92868Not yet recruiting
Canada , NSResearch Site Dartmouth, NS, Canada, B2W 6L4Not Yet Recruiting
United States of America , MDResearch Site White Marsh, MD, United States of America, 21162Recruiting
United States of America , OHResearch Site Cincinnati, OH, United States of America, 45229Recruiting
United States of America , FLResearch Site St. Petersburg, FL, United States of America, 33709Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10029Recruiting
United States of America , UTResearch Site Murray, UT, United States of America, 84107Recruiting
United States of America , UTResearch Site Salt Lake City, UT, United States of America, 84132Not yet recruiting
NetherlandsResearch Site Amsterdam, Netherlands, 1105 AZRecruiting
NetherlandsResearch Site NIEUWEGEIN, Netherlands, 3435 CMRecruiting
NetherlandsResearch Site Nijmegen, Netherlands, 6525 GARecruiting
IsraelResearch Site AFULA, Israel, Recruiting
IsraelResearch Site Haifa, Israel, 34362Withdrawn
IsraelResearch Site Holon, Israel, 58100Recruiting
IsraelResearch Site Jerusalem, Israel, 91120Not Yet Recruiting
IsraelResearch Site Kfar-Saba, Israel, 4428164Recruiting
IsraelResearch Site Petach-Tikva, Israel, 4920235Recruiting
IsraelResearch Site Tel Aviv, Israel, 64239Recruiting
ItalyResearch Site Firenze, Italy, 50134Not Yet Recruiting
ItalyResearch Site Genova, Italy, 16132Not Yet Recruiting
ItalyResearch Site NAPOLI, Italy, 80131Recruiting
ItalyResearch Site PISA, Italy, 56124Not Yet Recruiting
ItalyResearch Site ROZZANO, Italy, 20089Recruiting
ItalyResearch Site Verona, Italy, 37126Recruiting
United States of America , MNResearch Site Rochester, MN, United States of America, 55905Recruiting
FranceResearch Site Dijon Cedex, France, 21079Recruiting
FranceResearch Site Lille, France, F-59037Recruiting
FranceResearch Site LILLE CEDEX, France, 59037Recruiting
FranceResearch Site LYON CEDEX 03, France, 69437Recruiting
FranceResearch Site Pierre benite, France, 69495Withdrawn
FranceResearch Site SURESNES CEDEX, France, 92151Recruiting
FranceResearch Site Toulouse Cedex 9, France, 31059Recruiting
United States of America , ARResearch Site Little Rock, AR, United States of America, 72202Recruiting
Russian FederationResearch Site Chelyabinsk, Russian Federation, 454091Recruiting
Russian FederationResearch Site Moscow, Russian Federation, 119992Recruiting
Russian FederationResearch Site Moscow, Russian Federation, 105066Withdrawn
Russian FederationResearch Site Moscow, Russian Federation, 111123Recruiting
Russian FederationResearch Site Omsk, Russian Federation, 644112Not Yet Recruiting
PolandResearch Site Gdańsk, Poland, 80-214Not Yet Recruiting
PolandResearch Site Knurów, Poland, 44-190Recruiting
PolandResearch Site Łódź, Poland, 93-338Recruiting
PolandResearch Site Lublin, Poland, 20-582Recruiting
PolandResearch Site Rzeszow, Poland, 35-302Recruiting
PolandResearch Site Szczecin, Poland, 71-434Recruiting
PolandResearch Site Warszawa, Poland, 04-141Recruiting
PolandResearch Site Warszawa, Poland, 02-507Recruiting
PolandResearch Site Wrocław, Poland, 50-449Not Yet Recruiting
JapanResearch Site Chiba-shi, Japan, 260-8677Recruiting
JapanResearch Site Izumo-shi, Japan, 693-8501Recruiting
JapanResearch Site Maebashi-shi, Japan, 371-8511Recruiting
JapanResearch Site Osaka, Japan, 637086Recruiting
United States of America , TXResearch Site Dallas, TX, United States of America, 75246Not Yet Recruiting
United States of America , TXResearch Site Garland, TX, United States of America, 75044Not Yet Recruiting
United States of America , NEResearch Site Lincoln, NE, United States of America, 68503Recruiting
United States of America , SCResearch Site Summerville, SC, United States of America, 29486Not Yet Recruiting
United States of America , VAResearch Site Richmond, VA, United States of America, 23219Not Yet Recruiting
United States of America , ALResearch Site Birmingham, AL, United States of America, 35213Not Yet Recruiting
United States of America , MIResearch Site Chesterfield, MI, United States of America, 48047Not Yet Recruiting
Canada , OntarioResearch Site Hamilton, Ontario, Canada, L8S 1G5Not Yet Recruiting

Oversight


Is IND/IDE protocol: Yes 
IND/IDE Grantor: CDER 
IND/IDE Number: 141097 
Has Expanded Access: No 
U.S. FDA-regulated Drug: Yes 
U.S. FDA-regulated Device: No 

More Information


No publications provided

Responsible Party:AstraZeneca
ClinicalTrials.gov Identifier:NCT04543409
Other Study ID Numbers:D3255C00001, 2019-002871-32

Keywords provided by AstraZeneca
Eosinophilic Esophagitis
EoE
Benralizumab

Additional Relevant MeSH terms:
Eosinophilic Esophagitis

Primary Outcome Measures:

  • 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 ] [ Designated as safety issue:  ]

  • Changes from baseline in Dysphagia Symptom Questionnaire (DSQ) [ Time Frame: Week 24 ] [ Designated as safety issue:  ]
    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:

  • Changes from baseline in Endoscopic Reference Score (EREFS) [ Time Frame: Week 24 ] [ Designated as safety issue:  ]
    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).

  • Esophageal histopathology findings [ Time Frame: Week 24 ] [ Designated as safety issue:  ]
    Histopathology findings analyzed by Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS). EoE-HSS assesses the severity (grade) and extent (stage) of abnormalities using a 4-point scale (0 normal; 3 maximum change)

  • Dysphagia-free days [ Time Frame: Week 24 ] [ Designated as safety issue:  ]
    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) [ Time Frame: Week 24 ] [ Designated as safety issue:  ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue:  ]

  • Changes from baseline in abdominal pain and nausea as captured by the daily diary. [ Time Frame: Week 24 ] [ Designated as safety issue:  ]

  • Changes from baseline in Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EOE-QoL-A) [ Time Frame: Week 24 ] [ Designated as safety issue:  ]
    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) [ Time Frame: Week 24 ] [ Designated as safety issue:  ]
    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.

  • Healthcare resource utilization [ Time Frame: Week 24 ] [ Designated as safety issue:  ]
    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) [ Time Frame: Week 24 ] [ Designated as safety issue:  ]
    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) [ Time Frame: Week 24 ] [ Designated as safety issue:  ]
    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.”

Other Pre-specified Outcome Measures:

  • Benralizumab Pharmacokinetics [ Time Frame: Minimum of 52 weeks ] [ Designated as safety issue:  ]
    Serum concentrations of benralizumab.

  • Immunogenicity of benralizumab [ Time Frame: Minimum of 52 weeks ] [ Designated as safety issue:  ]
    Immunogenicity of benralizumab assessed by ADA and nAb.

  • Safety and tolerability [ Time Frame: Minimum of 52 weeks ] [ Designated as safety issue:  ]
    - Percentage of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

ArmsAssigned Interventions
Experimental: Benralizumab
Benralizumab active solution will be administered SC to patients by healthcare professionals in this clinical
study using an accessorized prefilled syringe (APFS)
Biological/Vaccine: Benralizumab
Solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
 
Placebo Comparator: Placebo
Placebo solution will be administered SC to patients by healthcare professionals in this clinical study using an accessorized prefilled syringe (APFS)
Biological/Vaccine: Matching placebo
Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC), 1 mL fill volume