A Study of Benralizumab in Patients With Eosinophilic Esophagitis

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.