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)
- Conditions
- Eosinophilic gastritis and/or gastroenteritis allergic gastritis and/or gastroenteritis10017969
- Registration Number
- NL-OMON50900
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2
· Aged >= 12 years of age at the time of signing the ICF or informed
consent or assent form.
· Confirmed diagnosis of EG/EGE for at least 3 months prior to screening.
· Baseline Eosinophilic gastritis, with or without duodenitis, or eosinophilic
duodenitis alone confirmed by biopsy
with a gastric count of >=30 eosinophils/hpf in at least 5 hpfs and/or duodenal
eosinophil count >=30 eosinophils/hpf in at least 3 hpfs without any other cause
for the gastrointestinal eosinophilia.
· Symptoms including at least moderate abdominal pain, nausea, bloating, early
satiety, and/or loss of appetite
· Must be adherent to daily PRO assessments including at least 8 of 14 symptom
assessments in the 14 days prior to randomization
· If on background medications for EG/EGE, the medications should be stable at
least 4 weeks prior to the run-in period.
· Willing and able to comply with all study procedures and visit schedule
including follow-up visits
· Women of childbearing potential must agree to use a highly effective form of
birth control (confirmed by the Investigator) from randomization throughout the
study duration and within 12 weeks after last dose if IP.
· Other gastrointestinal disorders such as active Helicobacter pylori
infection, history of achalasia, esophageal varices, Crohn's disease,
ulcerative colitis, inflammatory bowel disease, or celiac disease.
· Hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis.
· Current malignancy, or history of malignancy, except for patients who have
had basal
cell, localized squamous cell carcinoma of the skin, or in situ carcinoma of
the cervix are
eligible provided that the patient is in remission and curative therapy was
completed at
least 12 months prior to the date of informed consent.
· History of anaphylaxis to any biologic therapy or vaccine.
· Current active liver disease.
· Helminth parasitic infection diagnosed within 24 weeks prior to the date
informed that has not been treated with or has failed to respond to standard of
care therapy.
· Known immunodeficiency disorder including testing positive for HIV.
· Concomitant use of immunosuppressive medication.
· Receipt of live attenuated vaccines 30 days prior to date of informed
consent or assent.
· Receipt of inactive vaccines within 7 days of informed consent or assent.
· Initiation or change of a food-elimination diet regimen or re-introduction of
a previously
eliminated food group from 6 weeks prior to start of the run-in period and
unable or
unwilling to remain on a stable diet until the completion of Week 52.
· Currently pregnant or breast-feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective Part A/B: To compare the effect of benralizumab 30 mg every 4<br /><br>weeks (Q4W) with placebo on histologic signs and gastrointestinal symptoms in<br /><br>patients with eosinophilic gastritis and/or gastroenteritis.<br /><br><br /><br>Histology-based Dual-primary endpoints/variables: Proportion of patients<br /><br>achieving a histological response (defined as <=6 eosinophils/hpf in the stomach<br /><br>and/or, <=15 eosinophils/hpf in the duodenum) at Week 24.<br /><br>Symptom-based dual primary endpoint: Symptom Endpoint: Absolute change from<br /><br>baseline in SAGED Score at Week 24<br /><br><br /><br>Symptom based Endpoint: Absolute change from baseline in SAGED Score at Week 24</p><br>
- Secondary Outcome Measures
Name Time Method