Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
NCT ID: NCT05251909
Last Updated: 2025-07-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
12 participants
INTERVENTIONAL
2022-01-18
2024-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Benralizumab
This arm is a subcutaneous dose of Benralizumab
Benralizumab
Benralizumab is a humanized, afucosylated, monoclonal antibody that binds specifically to the IL-5Rα on the target cell and thus directly depletes eosinophils through antibody-dependent cell-mediated cytotoxicity. Benralizumab has been widely approved for treatment of asthma.
Placebo
This arm is a subcutaneous dose of Placebo
Placebo
Placebo will be injected as a comparator to injection with Benralizumab to examine effect on both the signs and symptoms of EG/EGE and the underlying eosinophilic inflammation, with dual primary outcome variables
Interventions
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Benralizumab
Benralizumab is a humanized, afucosylated, monoclonal antibody that binds specifically to the IL-5Rα on the target cell and thus directly depletes eosinophils through antibody-dependent cell-mediated cytotoxicity. Benralizumab has been widely approved for treatment of asthma.
Placebo
Placebo will be injected as a comparator to injection with Benralizumab to examine effect on both the signs and symptoms of EG/EGE and the underlying eosinophilic inflammation, with dual primary outcome variables
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
12 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Marc E. Rothenberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cincinnati Children's Hospital Medical Center 3333 Burnet Ave, Cincinnati Ohio 45229, United States
Locations
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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
Padua, , 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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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909\_HUDSON\_Poster\_non-US.pdf
Other Identifiers
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2021-000085-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D3258C00001
Identifier Type: -
Identifier Source: org_study_id
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