drugset / Trial / NCT05251909

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

NCT05251909

Phase 3 Terminated 12 enrolled AstraZeneca
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2022-01-18
Primary completion
2024-02-13
Completion
2024-02-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Benralizumab Monoclonal antibody Subcutaneous