Clinical Trials

Inclusion Criteria:

• Participant must be at least 12 years of age at the time of signing the ICF or informed assent form.
• Clinician confirmed diagnosis of EG/EGE for at least 3 months prior to screening.
• Participants who have documented previous diagnosis of eosinophilic gastritis, with or without duodenitis, or eosinophilic duodenitis alone. This will be confirmed by biopsy for the purpose of this study, defined as a gastric count of ≥ 30 eosinophils/hpf in at least 5 hpfs and and/or duodenal eosinophil count ≥30 eosinophils/hpf in at least 3 hpfs without any other cause for the gastrointestinal eosinophilia (e.g., parasitic or other infection or malignancy). Participants can have duodenal only disease and be enrolled in the duodenal only subject population. 
• At Visit 1 (screening), participants who in the investigator’s judgement have a history of symptoms of abdominal pain, nausea, bloating, early satiety, and/or loss of appetite to an extent that they would meet criteria 5 at Visit 2.
• At Visit 2 (randomisation), participants who are symptomatic, defined as having a mean SAGED score > 12 (on a 0 to 50 point scale) over the last 14 days of the run-in period.
• Must be adherent to daily PRO assessments:
  • Must complete 70% SAGED, DSQ, and Bristol Stool Form Scale assessments between Visit 1 and Visit 2; AND
  • Must have completed at least 8 of 14 SAGED assessments in the 14 days prior to randomization.
• If on background medications for EG/EGE during the study, background medications have been stable for at least 4 weeks prior to the run-in period.
  • Patient must agree not to change type of background medication or dosage during the study unless medically indicated or allowed by protocol during Part C OLE after Week 52 as clinically indicated. If a medication for EG/EGE (including swallowed steroids, systemic steroids and PPI) is discontinued prior to screening, there should be a washout period of at least 8 weeks prior to screening. 
• Negative serum pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (enrollment).
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Female participants:
  • Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age-specific requirements apply:
  • Women < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and have follicle stimulating hormone levels in the postmenopausal range.  Until FSH is documented to be within menopausal range, she should be treated as a WOCBP:
    • Women ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.
• Female participants that are WOCBP must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. WOCBP who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control, as defined below, from enrollment throughout the study and until at least 12 weeks after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together. All women of child bearing potential must have a negative serum pregnancy test result at Visit 1.
• Highly effective birth control methods include:
  • Combined (estrogen and progestogen ) hormonal contraception associated with ;inhibition of ovulation- oral, intravaginal, or transdermal
  • Progestogen-only hormonal contraception associated with inhibition of ovulation- oral, injectable, or implantable;
  • Intrauterine device;
  • Intrauterine hormone-releasing system;
  • Bilateral tubal occlusion;
  • Sexual abstinence, ie refraining from heterosexual intercourse (The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient);
  • Vasectomized sexual partner provided that partner is the sole sexual partner of the WOCBP study patient and that the vasectomized partner has received medical assessment of the surgical success.
• Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

• Any disorder, including, but not limited to, cardiovascular, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
  • Affect the safety of the patient throughout the study;
  • Influence the findings of the studies or their interpretations;
  • Impede the patient’s ability to complete the entire duration of study.
• Other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, or celiac disease.
• Hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis.
• Current malignancy, or history of malignancy, except for patients who have had basal cell, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date of informed consent, and assent when applicable was obtained. Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent, and assent when applicable, was obtained.
• 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. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis;
  • Alanine aminotransferase or aspartate aminotransferase level > 3 times the upper limit of normal, confirmed by repeated testing during the run-in period. Transient increase of aspartate aminotransferase/alanine aminotransferase level that resolves by the time of randomization is acceptable if in the Investigator's opinion the patient does not have an active liver disease and meets other eligibility criteria.
• 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.
• Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during run-in period, which in the opinion of the Investigator, may put the patient at risk, because of his/her participation in the study, or may influence the results of the study, or the patients' ability to complete entire duration of the study.
• Known immunodeficiency disorder including testing positive for HIV.
• Concomitant use of immunosuppressive medication (including but not limited to:
  • methotrexate, cyclosporine, and azathioprine.
• Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent or assent is obtained.
• Receipt of live attenuated vaccines 30 days prior to date of informed consent or assent.
• Receipt of inactive vaccines within 7 days of informed consent or assent.
• Receipt of any marketed or investigational biologic (monoclonal or polyclonal antibody) within 4 months or 5 half-lives prior to the date informed consent or assent (if applicable), is obtained, whichever is longer, and during the study period.
• Previous participation in a benralizumab clinical study.
• Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives prior to randomization, whichever is longer.
• Participants with a known hypersensitivity to benralizumab or any of the excipients of the product.
• Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group from 6 weeks prior to start of the run-in period and unable or unwilling to remain on a stable diet until the completion of Week 52.
• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• Judgment by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
• For women: currently pregnant confirmed with positive pregnancy test or breast-feeding.

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.