Phase
Condition
Heartburn (Pediatric)
Esophageal Disorders
Heartburn
Treatment
Matching placebo
Benralizumab
Clinical Study ID
Ages 12-65 All Genders
Study Summary
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):
- 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
- 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
Connect with a study center
Research Site
Dartmouth, Nova Scotia B2W 6L4
CanadaSite Not Available
Research Site
Hamilton, Ontario L8S 1G5
CanadaSite Not Available
Research Site
London, Ontario N6A 5W9
CanadaSite Not Available
Research Site
Ottawa, Ontario K1H 1E4
CanadaSite Not Available
Research Site
Windsor, Ontario N8X 2G1
CanadaSite Not Available
Research Site
Dijon Cedex, 21079
FranceSite Not Available
Research Site
Lille, F-59037
FranceSite Not Available
Research Site
Lille Cedex, 59037
FranceSite Not Available
Research Site
Lyon Cedex 03, 69437
FranceSite Not Available
Research Site
Pessac, 33600
FranceSite Not Available
Research Site
Pierre benite, 69495
FranceSite Not Available
Research Site
Suresnes Cedex, 92151
FranceSite Not Available
Research Site
Toulouse Cedex 9, 31059
FranceSite Not Available
Research Site
Berlin, 10825
GermanySite Not Available
Research Site
Dresden, 1307
GermanySite Not Available
Research Site
Frankfurt, 60590
GermanySite Not Available
Research Site
Hamburg, 20249
GermanySite Not Available
Research Site
Leipzig, 04129
GermanySite Not Available
Research Site
München, 80337
GermanySite Not Available
Research Site
Remscheid, 42859
GermanySite Not Available
Research Site
Weyhe, 28844
GermanySite Not Available
Research Site
Afula, 18341
IsraelSite Not Available
Research Site
Haifa, 34362
IsraelSite Not Available
Research Site
Holon, 58100
IsraelSite Not Available
Research Site
Jerusalem, 91120
IsraelSite Not Available
Research Site
Kfar-Saba, 4428164
IsraelSite Not Available
Research Site
Petach-Tikva, 4920235
IsraelSite Not Available
Research Site
Tel Aviv, 64239
IsraelSite Not Available
Research Site
Firenze, 50134
ItalySite Not Available
Research Site
Genova, 16126
ItalySite Not Available
Research Site
Napoli, 80131
ItalySite Not Available
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Pisa, 56124
ItalySite Not Available
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Rozzano, 20089
ItalySite Not Available
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Verona, 37134
ItalySite Not Available
Research Site
Chiba, 260-0877
JapanSite Not Available
Research Site
Chiba-Shi, 260-0877
JapanSite Not Available
Research Site
Chiba-shi, 260-8677
JapanSite Not Available
Research Site
Izumo-shi, 693-8501
JapanSite Not Available
Research Site
Maebashi-shi, 371-8511
JapanSite Not Available
Research Site
Nagoya-shi, 457-8511
JapanSite Not Available
Research Site
Osaka, 637086
JapanSite Not Available
Research Site
Osaka-shi, 545-8586
JapanSite Not Available
Research Site
Saga-shi, 840-8571
JapanSite Not Available
Research Site
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Research Site
Nieuwegein, 3435 CM
NetherlandsSite Not Available
Research Site
Nijmegen, 6525 GA
NetherlandsSite Not Available
Research Site
Białystok, 15-545
PolandSite Not Available
Research Site
Gdańsk, 80-214
PolandSite Not Available
Research Site
Knurów, 44-190
PolandSite Not Available
Research Site
Lublin, 20-582
PolandSite Not Available
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Rzeszow, 35-302
PolandSite Not Available
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Szczecin, 71-434
PolandSite Not Available
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Warszawa, 04-141
PolandSite Not Available
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Wrocław, 50-449
PolandSite Not Available
Research Site
Łódź, 93-338
PolandSite Not Available
Research Site
Chelyabinsk, 454091
Russian FederationSite Not Available
Research Site
Moscow, 105066
Russian FederationSite Not Available
Research Site
Omsk, 644112
Russian FederationSite Not Available
Research Site
Yaroslavl, 150054
Russian FederationSite Not Available
Research Site
Badalona, 08916
SpainSite Not Available
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Barcelona, 08036
SpainSite Not Available
Research Site
Bilbao, 48013
SpainSite Not Available
Research Site
Bilbao (Vizcaya), 48013
SpainSite Not Available
Research Site
Madrid, 28031
SpainSite Not Available
Research Site
Brighton, BN2 5BE
United KingdomSite Not Available
Research Site
Darlington, DL3 6HX
United KingdomSite Not Available
Research Site
Leicester, Le5 4PW
United KingdomSite Not Available
Research Site
London, SW17 0RE
United KingdomSite Not Available
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Manchester, M13 9WL
United KingdomSite Not Available
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Birmingham, Alabama 35213
United StatesSite Not Available
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Little Rock, Arkansas 72202
United StatesSite Not Available
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La Jolla, California 92037
United StatesSite Not Available
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Orange, California 92868
United StatesSite Not Available
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Santa Monica, California 90404
United StatesSite Not Available
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Stanford, California 94305
United StatesSite Not Available
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Jacksonville, Florida 32207
United StatesSite Not Available
Research Site
Saint Petersburg, Florida 33709
United StatesSite Not Available
Research Site
Atlanta, Georgia 30322-1013
United StatesSite Not Available
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Chicago, Illinois 60611
United StatesSite Not Available
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Normal, Illinois 61761
United StatesSite Not Available
Research Site
Park Ridge, Illinois 60068
United StatesSite Not Available
Research Site
Peoria, Illinois 61603
United StatesSite Not Available
Research Site
White Marsh, Maryland 21162
United StatesSite Not Available
Research Site
Boston, Massachusetts 02111
United StatesSite Not Available
Research Site
Chesterfield, Michigan 48047
United StatesSite Not Available
Research Site
Rochester, Minnesota 55905
United StatesSite Not Available
Research Site
Lincoln, Nebraska 68510
United StatesSite Not Available
Research Site
Omaha, Nebraska 68124
United StatesSite Not Available
Research Site
Ocean City, New Jersey 07712
United StatesSite Not Available
Research Site
New York, New York 10029
United StatesSite Not Available
Research Site
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Research Site
Charlotte, North Carolina 28277
United StatesSite Not Available
Research Site
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Research Site
Cincinnati, Ohio 45229
United StatesSite Not Available
Research Site
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Research Site
Uniontown, Pennsylvania 15401
United StatesSite Not Available
Research Site
Summerville, South Carolina 29486
United StatesSite Not Available
Research Site
Dallas, Texas 75246
United StatesSite Not Available
Research Site
Garland, Texas 75044
United StatesSite Not Available
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Houston, Texas 77030
United StatesSite Not Available
Research Site
Murray, Utah 84107
United StatesSite Not Available
Research Site
Salt Lake City, Utah 84107
United StatesSite Not Available
Research Site
Charlottesville, Virginia 22908
United StatesSite Not Available
Research Site
Richmond, Virginia 23219
United StatesSite Not Available
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