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Benralizumab for Eosinophilic Gastritis
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Benralizumab (Anti-IL5RA) in Subjects With Eosinophilic Gastritis.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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|Eligible Ages||12 Years - 60 Years|
- - Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form.
- - Males and females between the ages of 12-60 years with confirmed diagnosis of EG involving stomach; involvement of eosinophilic inflammation in other gastrointestinal segments will be allowed but not required or sufficient.
- - Histologically active EG at time of screening, with a peak Gastric count of ≥ 30 eos/hpf in at least 5 hpfs.
- - Must be symptomatic (defined as having experienced symptoms within 4 weeks prior to enrollment) - Blood eosinophilia (defined as having an absolute eosinophil count > 500 cells per mcL of blood ) at least once during the 6 months prior to enrollment.
- - Must be on baseline anti-EG/EGE therapy as long as there is agreement to not change their dosage unless medically indicated.
- - Clinical symptoms (i.e., abdominal pain, bloating, vomiting, diarrhea) severe enough to impact daily life (e.g., school/work attendance, social activities) ≥ 2 days/week for 3 of the 4 weeks prior to enrollment despite treatment (such as diet, proton pump inhibitors or corticosteroids).
- - Female subjects: Women of childbearing potential (WOCBP) must use an effective form of birth control (confirmed by the Investigator).
- - Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
- - Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.
- - Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
- - All male subjects who are sexually active must agree to use an acceptable method of contraception (condom with or without spermicide, vasectomy) from Visit 0 until 16 weeks after their last dose.
- - Concurrent H.
- - Other gastrointestinal disorders such as Crohn's disease, inflammatory bowel disease, or Celiac disease - Esophageal stricture that prevents the easy passage of a standard endoscope - Use of any investigational biologic drug within 6 months prior to screening - Hypereosinophilic syndrome, defined by multiple organ involvement (with the exception of atopic disease or EGID) and persistent blood absolute eosinophil count ≥1500/mcL.
- - A diagnosis of celiac disease, inflammatory bowel disease, eosinophilic granulomatosis with polyangiitis (EGPA), drug hypersensitivity or connective tissue rheumatological disorders, - History of cancer: Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date informed consent, and assent when applicable was obtained.
- - A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.
- - Pregnant or nursing - Receipt of any investigational non-biologic within 30 days or 5 half-lives prior to visit 0, whichever is longer.
- - A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
- - Any other medical illness that precludes study involvement - Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C.
- - Patients who are currently receiving or have previously received benralizumab or any other type of anti-interleukin therapy (i.e. mepolizumab, reslizumab, lebrikizumab etc.) within the last 6 months or 5 half-lives whichever is longer.
- - History of anaphylaxis to any biologic therapy or vaccine.
- - Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Children's Hospital Medical Center, Cincinnati|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|marc E Rothenberg, MD, PhD|
|Principal Investigator Affiliation||Children's Hospital Medical Center, Cincinnati|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Eosinophilic Gastritis or Gastroenteritis|
Primary Objective: To assess the efficacy of repeat subcutaneous (SC) doses of benralizumab, compared with placebo, to reduce eosinophilic inflammation in the gastrointestinal tract of patients with EG Secondary Objectives: To assess changes in endoscopic score/histological features/blood and biopsy eosinophil counts/clinical symptoms/esophageal, gastric, and duodenal tissue transcriptome changes/ before and after treatment with benralizumab. 26 subjects are planned to be enrolled into the study at Cincinnati Children's Hospital Medical Center. Qualifying Subjects will receive 3 monthly sub-coetaneous injections of benralizumab/Placebo, followed by an option six month Open Label Extension period.
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229