A Study of Benralizumab in Patients With Eosinophilic Esophagitis

Last updated: October 31, 2023
Sponsor: AstraZeneca
Overall Status: Terminated

Phase

3

Condition

Heartburn (Pediatric)

Esophageal Disorders

Heartburn

Treatment

Matching placebo

Benralizumab

Clinical Study ID

NCT04543409
D3255C00001
2019-002871-32
  • Ages 12-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 12 to 65 years of age, inclusive, at the time of signing the informed consentor 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 ofdysphagia 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 ofdysphagia (Daily DSQ ≥2) in each of the 2 weeks immediately prior torandomization
  • May be on background medications for EoE and related treatments during the study aslong as the background medications have been stable for at least 4 weeks (8 weeks forPPI) prior to the screening and there is agreement not to change type of backgroundmedication or dosage during the run-in period and for the first 52 weeks of the studyunless 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 birthcontrol (confirmed by the Investigator) from randomization throughout the studyduration and within 12 weeks after last dose if IP.

Exclusion

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 anycritical esophageal stricture that requires dilation during the run-in period.
  • Esophageal dilation performed within 8 weeks prior to screening and prior esophagealsurgery that would impact the assessments for EoE
  • Use of a feeding tube, or having a pattern of not eating solid food daily during therun-in period.
  • Hypereosinophilic syndrome, defined by multiple organ involvement and persistent bloodeosinophil 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 Bsurface antigen [HBsAg] or hepatitis C antibody), or other stable chronic liverdisease are acceptable if patient otherwise meets eligibility criteria.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 timesthe upper limit of normal (ULN), confirmed by repeated testing during the run-inperiod.
  • Helminth parasitic infection diagnosed within 24 weeks prior to the date informedconsent or assent (if applicable) is obtained that has not been treated with or hasfailed to respond to standard of care therapy.
  • History of known immunodeficiency disorder including a positive human immunodeficiencyvirus (HIV) test.
  • Concomitant use of immunosuppressive medication.
  • Initiation or change of a food-elimination diet regimen or reintroduction of apreviously eliminated food group in the 6 weeks prior to start of the run-in period.
  • Currently pregnant, breastfeeding, or lactating women.

Study Design

Total Participants: 211
Treatment Group(s): 2
Primary Treatment: Matching placebo
Phase: 3
Study Start date:
September 22, 2020
Estimated Completion Date:
February 06, 2023

Connect with a study center

  • Research Site

    Dartmouth, Nova Scotia B2W 6L4
    Canada

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  • Research Site

    Hamilton, Ontario L8S 1G5
    Canada

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    London, Ontario N6A 5W9
    Canada

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    Ottawa, Ontario K1H 1E4
    Canada

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    Windsor, Ontario N8X 2G1
    Canada

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    Dijon Cedex, 21079
    France

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  • Research Site

    Lille, F-59037
    France

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  • Research Site

    Lille Cedex, 59037
    France

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  • Research Site

    Lyon Cedex 03, 69437
    France

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    Pessac, 33600
    France

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  • Research Site

    Pierre benite, 69495
    France

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  • Research Site

    Suresnes Cedex, 92151
    France

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    Toulouse Cedex 9, 31059
    France

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    Berlin, 10825
    Germany

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    Dresden, 1307
    Germany

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    Frankfurt, 60590
    Germany

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    Hamburg, 20249
    Germany

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    Leipzig, 04129
    Germany

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    München, 80337
    Germany

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    Remscheid, 42859
    Germany

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    Weyhe, 28844
    Germany

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    Afula, 18341
    Israel

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    Haifa, 34362
    Israel

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    Holon, 58100
    Israel

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    Jerusalem, 91120
    Israel

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    Kfar-Saba, 4428164
    Israel

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    Petach-Tikva, 4920235
    Israel

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    Tel Aviv, 64239
    Israel

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    Firenze, 50134
    Italy

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    Genova, 16126
    Italy

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    Napoli, 80131
    Italy

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    Pisa, 56124
    Italy

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    Rozzano, 20089
    Italy

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    Verona, 37134
    Italy

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    Chiba, 260-0877
    Japan

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    Chiba-Shi, 260-0877
    Japan

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    Chiba-shi, 260-8677
    Japan

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    Izumo-shi, 693-8501
    Japan

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    Maebashi-shi, 371-8511
    Japan

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    Nagoya-shi, 457-8511
    Japan

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    Osaka, 637086
    Japan

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    Osaka-shi, 545-8586
    Japan

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    Saga-shi, 840-8571
    Japan

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    Amsterdam, 1105 AZ
    Netherlands

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    Nieuwegein, 3435 CM
    Netherlands

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    Nijmegen, 6525 GA
    Netherlands

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    Białystok, 15-545
    Poland

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    Gdańsk, 80-214
    Poland

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    Knurów, 44-190
    Poland

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    Lublin, 20-582
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    Rzeszow, 35-302
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    Szczecin, 71-434
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    Warszawa, 04-141
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    Wrocław, 50-449
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    Łódź, 93-338
    Poland

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    Chelyabinsk, 454091
    Russian Federation

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    Moscow, 105066
    Russian Federation

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    Omsk, 644112
    Russian Federation

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    Yaroslavl, 150054
    Russian Federation

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    Badalona, 08916
    Spain

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    Barcelona, 08036
    Spain

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    Bilbao, 48013
    Spain

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    Bilbao (Vizcaya), 48013
    Spain

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    Madrid, 28031
    Spain

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    Brighton, BN2 5BE
    United Kingdom

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    Darlington, DL3 6HX
    United Kingdom

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    Leicester, Le5 4PW
    United Kingdom

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    London, SW17 0RE
    United Kingdom

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    Manchester, M13 9WL
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    Birmingham, Alabama 35213
    United States

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    Little Rock, Arkansas 72202
    United States

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    La Jolla, California 92037
    United States

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    Orange, California 92868
    United States

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    Santa Monica, California 90404
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    Stanford, California 94305
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    Jacksonville, Florida 32207
    United States

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    Saint Petersburg, Florida 33709
    United States

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    Atlanta, Georgia 30322-1013
    United States

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    Chicago, Illinois 60611
    United States

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    Normal, Illinois 61761
    United States

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    Park Ridge, Illinois 60068
    United States

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    Peoria, Illinois 61603
    United States

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    White Marsh, Maryland 21162
    United States

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    Boston, Massachusetts 02111
    United States

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    Chesterfield, Michigan 48047
    United States

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    Rochester, Minnesota 55905
    United States

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    Lincoln, Nebraska 68510
    United States

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    Omaha, Nebraska 68124
    United States

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    Ocean City, New Jersey 07712
    United States

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    New York, New York 10029
    United States

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    Chapel Hill, North Carolina 27514
    United States

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    Charlotte, North Carolina 28277
    United States

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    Winston-Salem, North Carolina 27157
    United States

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    Cincinnati, Ohio 45229
    United States

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    Philadelphia, Pennsylvania 19104
    United States

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    Uniontown, Pennsylvania 15401
    United States

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    Summerville, South Carolina 29486
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    Dallas, Texas 75246
    United States

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    Garland, Texas 75044
    United States

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    Houston, Texas 77030
    United States

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    Murray, Utah 84107
    United States

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    Salt Lake City, Utah 84107
    United States

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    Charlottesville, Virginia 22908
    United States

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  • Research Site

    Richmond, Virginia 23219
    United States

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