Study identifier:D3258C00001
ClinicalTrials.gov identifier:NCT05251909
EudraCT identifier:2021-000085-14
CTIS identifier:N/A
A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
Eosinophilic gastritis
Phase 3
No
-
All
12
Interventional
12 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
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.
Location
Location
Amsterdam, Netherlands, 1105 AZ
Location
Chapel Hill, NC, United States, 27599
Location
Salt Lake City, UT, United States, 84107
Location
Philadelphia, PA, United States, 19104
Location
Chicago, IL, United States, 60611
Location
Shinjuku-ku, Japan, 162-8655
Location
Bunkyo-ku, Japan, 113-8603
Location
Maebashi-shi, Japan, 371-8511
Arms | Assigned Interventions |
---|---|
Experimental: Benralizumab This arm is a subcutaneous dose of Benralizumab | Biological/Vaccine: 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. Other Name: Fasenra |
Placebo Comparator: Placebo This arm is a subcutaneous dose of Placebo | Biological/Vaccine: 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 |
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