Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
Brief Summary:
This is a 3-part study. Part A and B have identical designs and are randomized, double-blinded, placebo-controlled studies, which will include patients with eosinophilic gastritis and/or duodenal-only disease. Part A will be enrolled first, followed by Part B. After completing Part A or Part B, participants will continue to Part C - open-label benralizumab treatment period.
Detailed Description:
The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with Eosinophilic Gastritis and/or Gastroenteritis. The effect of doses of benralizumab on EG/EGE histologic signs and symptoms will be assessed in a 24-week double-blind placebo-controlled treatment period followed by assessments during an open-label benralizumab treatment period. It is proposed that benralizumab will deplete eosinophilis, improve the symptoms in patients with eosinophilic gastritis and/or gastroenteritis, and improve histologic scores as well as other markers of disease activity.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: This is a parallel-group efficacy and safety study with 2 arms that are participant and investigator blinded, with an open-label extension.
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date: January 18, 2022
Estimated Primary Completion Date: January 26, 2024
Estimated Study Completion Date: January 26, 2024
Arm:
- Experimental: Benralizumab
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Actual enrolment | 12 |
| Actual Study start date | 18 January 2022 |
| Estimated Study Completion Date | 26 January 2024 |