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

Phase 3

Completed

• Conditions: Eosinophilic Gastroenteritis; Eosinophilic Gastritis
• Interventions: Biological: Placebo; Biological: Benralizumab

• Registration Number: NCT05251909
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-06
• Study Start: 2022-01-18
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-23
• Status Verified: 2024-02
• Primary Completion: 2024-02-13
• Study Completion: 2024-02-13
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	This arm is a subcutaneous dose of Placebo
Benralizumab	Benralizumab	This arm is a subcutaneous dose of Benralizumab

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving a histological response in the stomach and/or in the duodenum	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Absolute change from baseline in SAGED (Symptom Assessment for Gastrointestinal Eosinophilic Diseases) Score (range: 0-50). SAGED score measures gastrointestinal symptoms with higher scores meaning worse outcome	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.

Secondary Outcome Measures

Name	Time	Method
Vomiting-free days	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Proportion achieving treatment response	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Diarrhea-free days	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Immunogenicity of benralizumab in patients (with EG/EGE)	Minimum 24 weeks	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Percent change in tissue eosinophils	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
PAGI-QoL score	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Frequency of diarrhea episodes	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Frequency of vomiting episodes	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Proportion of patients with no rescue corticosteroid use	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Health-related quality of life measured as change from baseline in SF-36v2 (the Short Form 36-item Health Survey, Version 2) which has two components: Physical Component Summary (PCS) and Mental Component Summary (MCS).	Week 24	The score range for PCS and MCS is 0-100; higher scores indicate better health state.; Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Diarrhea and constipation free days	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Clinically meaningful symptom change. Time to clinically meaningful change in SAGED score (range: 0-50) measures gastrointestinal symptoms with higher scores meaning worse outcome.	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
PROMIS Fatigue 7a score	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
PAGI-SYM score	Week 24	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Pharmacokinetics of benralizumab in patients (with EG/EGE)	Minimum 24 weeks	Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.

Trial Locations

Locations (1)

Research Site; 🇻🇳 Hanoi, Vietnam