NCT05251909

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

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Eosinophilic Gastritis
• Eosinophilic Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	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.
BIOLOGICAL	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

Timeline

• Start date: 2022-01-18
• Primary completion: 2024-02-13
• Completion: 2024-02-13
• First posted: 2022-02-23
• Last updated: 2025-07-14
• Results posted: 2025-07-14

Locations

20 sites across 9 countries: United States, Brazil, Italy, Japan, Netherlands, Poland, Spain, Ukraine, Vietnam

Regulatory

• FDA-regulated drug study