A Study of Benralizumab in Patients With Eosinophilic Esophagitis

  • End date
    Mar 22, 2024
  • participants needed
  • sponsor
Updated on 27 September 2021
AstraZeneca Clinical Study Information Center
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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.

Condition Eosinophilic esophagitis
Treatment benralizumab, Matching Placebo
Clinical Study IdentifierNCT04543409
Last Modified on27 September 2021


Yes No Not Sure

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
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
An average of at least 2 days per week with an episode of dysphagia (Daily DSQ
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
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/L
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
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