Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
- Conditions
- Eosinophilic GastroenteritisEosinophilic Gastritis
- Interventions
- Biological: Placebo
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Benralizumab Benralizumab This arm is a subcutaneous dose of Benralizumab Placebo Placebo This arm is a subcutaneous dose of Placebo
- Primary Outcome Measures
Name Time Method Proportion of Patients With a Histologic Response at Week 24 at week 24 the proportion of patients achieving a histological response at Week 24, is defined as below:
* 6 eosinophils/hpf in the stomach for the patients with only gastric disease at baseline.
* 6 eosinophils/hpf in the stomach and ≤15 eosinophils/hpf in the duodenum for the patients with gastric + duodenal disease at baseline.
* 15 eosinophils/hpf in the duodenum for the patients with only duodenal disease at baseline.Change From Baseline in SAGED Score at Week 24 at week 24 The Symptom Assessment for Gastrointestinal Eosinophilic Diseases (SAGED) instrument was developed to measure gastrointestinal symptoms in participants diagnosed with EG/EGE. It is a daily diary completed by participants each evening from screening until week 76 to record symptoms during the past 24 hours. Severity for each concept is assessed using an 11-point numerical rating scale (0 = 'none' and 10 = 'worst imaginable'). The total SAGED score (range 0-50) is calculated as a 14-day mean of the sum of individual severity items of abdominal pain, nausea, bloating, early satiety and loss of appetite daily. Higher scores indicate greater symptom severity. Three additional items are collected that aren't part of the total SAGED score and are considered separately: severity of vomiting, severity of diarrhoea and frequency of vomiting. Change in SAGED score at week 24 is the week 24 score (study days 155 to 168) minus the baseline score (study days -14 to -1).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇻🇳Hanoi, Vietnam
Research Site🇻🇳Hanoi, Vietnam