Eosinophilic Gastritis and/or Gastroenteritis MedDRA version: 23.0 Level: PT Classification code 10083619 Term: Eosinophilic gastritis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: PT Classification code 10017902 Term: Gastroenteritis eosinophilic System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · 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. Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 169 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: · 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PartA/B: To compare the effect of benralizumab with placebo on histologic signs and gastrointestinal symptoms in patients with eosinophilic gastritis and/or gastroenteritis;Secondary Objective: -Part A/B: To compare the effect of benralizumab with placebo on clinical features of eosinophilic gastritis/ gastroenteritis and disease activity. -Part A/B: To compare the effect of benralizumab with placebo on rescue corticosteroid use. -Part A/B: To compare the effect of benralizumab with placebo on health-related quality of life in patients with EG/EGE. -To assess the pharmacokinetics and immunogenicity of benralizumab in patients with EG/EGE. -To assess the safety of benralizumab in patients with eosinophilic gastritis and/or gastroenteritis.;Primary end point(s): Dual primary endpoints 1). Proportion of patients achieving a histological response in the stomach and/or in the duodenum Histologic Endpoint:defined as =6 eosinophils/high power field (hpf) in the stomach and/or, =15 eosinophils/hpf in the duodenum at Week 24 2). Absolute change in symptoms of EG/EGE;Timepoint(s) of evaluation of this end point: Both at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tissue eosinophilis -Percentage change from baseline in tissue eosinophils (stomach and/or duodenum if applicable) at Week 24 Treatment response -Proportion of patients who achieve treatment response: tissue remission (= 6 eosinophils/hpf in the stomach and = 15 eosinophils/hpf in the duodenum, if applicable) and an improvement in symptoms at Week 24 Diarrhea-free days - Change from baseline in proportion of diarrhea-free days, and change from baseline in frequency of diarrhea episodes at Week 24 Vomiting-free days - Change from baseline in proportion of vomiting-free days, and change from baseline in frequency of vomiting episodes at Week 24 To compare the effect of benralizumab with placebo on rescue use - Proportion of patients with no rescue corticosteroid use up to Week 24 To evaluate the effect of benralizumab on patient reported QOL measures at Week 24 Safety and tolerability - Safety and tolerability will be evaluated in terms of adverse events, vital signs, physical exam, and clinical laboratory parameters at Week 52;Timepoint(s) of evaluation of this end point: Depending on the endpoints/objective | — |
Countries
Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Netherlands, Poland, Spain, Switzerland, Ukraine, United States, Vietnam
Contacts
Public ContactUnidad de Investigación Clínica
AstraZeneca Farmacéutica Spain, S.A.
Outcome results
None listed