Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Eosinophilic Gastritis, Eosinophilic Gastroenteritis

In brief

This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease. After completing Part A, participants can continue to Part C - open-label benralizumab treatment period. Following the decision to close enrollment, patients in both Part A and Part C will be given the option to proceed to 6-months of open-label benralizumab treatment in Part D.

Key facts

Study ID: NCT05251909
Run by: AstraZeneca
People needed: 12
Starts: 2022-01-18
Expected to finish: 2024-02-13
Last updated by the study team: 2025-07-14

Who can join

Age: 12 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Aged >= 12 years of age at the time of signing the ICF or informed consent or assent form.
Confirmed diagnosis of EG/EGE for at least 3 months prior to screening.
Baseline Eosinophilic gastritis, with or without duodenitis, or eosinophilic duodenitis alone confirmed by biopsy with a gastric count of ≥30 eosinophils/hpf in at least 5 hpfs and/or duodenal eosinophil count ≥30 eosinophils/hpf in at least 3 hpfs without any other cause for the gastrointestinal eosinophilia.
Symptoms including at least moderate abdominal pain, nausea, bloating, early satiety, and/or loss of appetite
Must be adherent to daily PRO assessments including at least 8 of 14 symptom assessments in the 14 days prior to randomization
If on background medications for EG/EGE, the medications should be stable at least 4 weeks prior to the run-in period.
Willing and able to comply with all study procedures and visit schedule including follow-up visits
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.

You may not qualify if…

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.
History of anaphylaxis to any biologic therapy or vaccine.
Current active liver disease.
Helminth parasitic infection diagnosed within 24 weeks prior to the date informed that has not been treated with or has failed to respond to standard of care therapy.
Known immunodeficiency disorder including testing positive for HIV.
Concomitant use of immunosuppressive medication.
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.
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 Part A and C.
Currently pregnant or breast-feeding.

Where it is running

Research Site — Chicago, Illinois, United States
Research Site — Boston, Massachusetts, United States
Research Site — Rochester, Minnesota, United States
Research Site — Chapel Hill, North Carolina, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Salt Lake City, Utah, United States
Research Site — Salt Lake City, Utah, United States
Research Site — São Paulo, Brazil
Research Site — Milan, Italy
Research Site — Padova, Italy
Research Site — Pisa, Italy
Research Site — Bunkyō City, Japan
Research Site — Maebashi, Japan
Research Site — Ogaki-shi, Japan
Research Site — Shinjuku-ku, Japan
Research Site — Amsterdam, Netherlands
Research Site — Staszów, Poland
Research Site — Seville, Spain
Research Site — Kyiv, Ukraine
Research Site — Hanoi, Vietnam

Full record on ClinicalTrials.gov

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