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A Study of Benralizumab in Patients With Eosinophilic Esophagitis

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years - 65 Years
Gender All
More Inclusion & Exclusion 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.
  • - 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 16 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.
  • - Use of a feeding tube, or 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04543409
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AstraZeneca
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marc E. Rothenberg, MD, PhD
Principal Investigator Affiliation Children's Hospital Medical Center, Cincinnati
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Arms & Interventions

Arms

Experimental: Benralizumab

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

Placebo Comparator: Placebo

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

Interventions

Biological: - Benralizumab

Solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume

Biological: - Matching placebo

Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC), 1 mL fill volume

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Little Rock, Arkansas

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Little Rock, Arkansas, 72202

Research Site, Orange, California

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Orange, California, 92868

Research Site, Santa Monica, California

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Santa Monica, California, 90404

Research Site, Saint Petersburg, Florida

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Saint Petersburg, Florida, 33709

Research Site, Atlanta, Georgia

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Atlanta, Georgia, 30322-1013

Research Site, Chicago, Illinois

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Chicago, Illinois, 60611

Research Site, Normal, Illinois

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Normal, Illinois, 61761

Research Site, Park Ridge, Illinois

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Park Ridge, Illinois, 60068

Research Site, White Marsh, Maryland

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White Marsh, Maryland, 21162

Research Site, Boston, Massachusetts

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Boston, Massachusetts, 02111

Research Site, Boston, Massachusetts

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Boston, Massachusetts, 02115

Research Site, Rochester, Minnesota

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Rochester, Minnesota, 55905

Research Site, Ocean City, New Jersey

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Ocean City, New Jersey, 07712

Research Site, New York, New York

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New York, New York, 10029

Research Site, Chapel Hill, North Carolina

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Chapel Hill, North Carolina, 27599

Research Site, Winston-Salem, North Carolina

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Winston-Salem, North Carolina, 27157-1023

Research Site, Cincinnati, Ohio

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Cincinnati, Ohio, 45229-3039

Research Site, Philadelphia, Pennsylvania

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Philadelphia, Pennsylvania, 19104

Research Site, Dallas, Texas

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Dallas, Texas, 75246

Research Site, Murray, Utah

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Murray, Utah, 84107

Research Site, Salt Lake City, Utah

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Salt Lake City, Utah, 84132

International Sites

Research Site, Dartmouth, Nova Scotia, Canada

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Dartmouth, Nova Scotia, B2W 6L4

Research Site, Hamilton, Ontario, Canada

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Hamilton, Ontario, L8S 4L8

Research Site, London, Ontario, Canada

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London, Ontario, N6A 5W9

Research Site, Ottawa, Ontario, Canada

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Ottawa, Ontario, K1G 6C6

Research Site, Windsor, Ontario, Canada

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Windsor, Ontario, N8X 2G1

Research Site, Dijon Cedex, France

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Dijon Cedex, , 21079

Research Site, Lille Cedex, France

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Lille Cedex, , 59037

Research Site, Lille, France

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Lille, , F-59037

Research Site, Lyon Cedex 03, France

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Lyon Cedex 03, , 69437

Research Site, Pierre benite, France

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Pierre benite, , 69495

Research Site, Suresnes Cedex, France

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Suresnes Cedex, , 92151

Research Site, Toulouse Cedex 9, France

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Toulouse Cedex 9, , 31059

Research Site, Leipzig, Germany

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Leipzig, , 04129

Research Site, München, Germany

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München, , 80337

Research Site, München, Germany

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München, , 81675

Research Site, Afula, Israel

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Afula, ,

Research Site, Haifa, Israel

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Haifa, , 34362

Research Site, Holon, Israel

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Holon, , 58100

Research Site, Jerusalem, Israel

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Jerusalem, , 91120

Research Site, Kfar-Saba, Israel

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Kfar-Saba, , 4428164

Research Site, Petach-Tikva, Israel

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Petach-Tikva, , 4920235

Research Site, Tel Aviv, Israel

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Tel Aviv, , 64239

Research Site, Firenze, Italy

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Firenze, , 50134

Research Site, Genova, Italy

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Genova, , 16132

Research Site, Napoli, Italy

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Napoli, , 80131

Research Site, Pisa, Italy

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Pisa, , 56124

Research Site, Rozzano, Italy

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Rozzano, , 20089

Research Site, Verona, Italy

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Verona, , 37126

Research Site, Izumo-shi, Japan

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Izumo-shi, , 693-8501

Research Site, Osaka, Japan

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Osaka, , 637086

Research Site, Amsterdam, Netherlands

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Amsterdam, , 1105 AZ

Research Site, Nieuwegein, Netherlands

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Nieuwegein, , 3435 CM

Research Site, Nijmegen, Netherlands

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Nijmegen, , 6525 GA

Research Site, Knurów, Poland

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Knurów, , 44-190

Research Site, Lublin, Poland

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Lublin, , 20-582

Research Site, Rzeszow, Poland

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Rzeszow, , 35-302

Research Site, Szczecin, Poland

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Szczecin, , 71-434

Research Site, Warszawa, Poland

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Warszawa, , 02-507

Research Site, Warszawa, Poland

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Warszawa, , 04-141

Research Site, Wrocław, Poland

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Wrocław, , 50-449

Research Site, Łódź, Poland

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Łódź, , 93-338

Research Site, Moscow, Russian Federation

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Moscow, , 105066

Research Site, Moscow, Russian Federation

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Moscow, , 119992

Research Site, Yaroslavl, Russian Federation

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Yaroslavl, , 150054

Research Site, Badalona, Spain

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Badalona, , 08916

Research Site, Barcelona, Spain

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Barcelona, , 08035

Research Site, Barcelona, Spain

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Barcelona, , 08036

Research Site, Madrid, Spain

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Madrid, , 28006

Research Site, Madrid, Spain

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Madrid, , 28031

Research Site, Madrid, Spain

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Madrid, , 28040

Research Site, Brighton, United Kingdom

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Brighton, , BN2 5BE

Research Site, Darlington, United Kingdom

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Darlington, , DL3 6HX

Research Site, London, United Kingdom

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London, , E1 2AJ

Research Site, London, United Kingdom

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London, , SW17 0RE

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