Clinical Study Using Biologics to Improve Multi OIT Outcomes
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
Food allergy (FA) is a serious public health concern that causes potentially-life threatening
reactions in affected patients. The prevalence of food allergy in the United States (U.S.)
has increased substantially and now affects 15 million patients:4-8% of children (6 million
children, 30% with multiple food allergies) and about 9% of adults. This is a prospective
Phase 2, single-center, multi-allergen OIT study in participants with proven allergies to 2
or 3 different foods in which one must be a peanut. The total of participants in the clinical
study will be 110, ages 5 to 55 years with a history of multiple food allergies of 2 to 3
different foods including peanut. Allergy will be confirmed by FA-specific IgE levels and
positive skin prick test (SPT). Enrolled participants must be positive during the
Double-blind Placebo-controlled Food challenge (DBPCFC) at or before the 300 mg (444 mg
cumulative) dosing level of FA proteins.
Phase:
Phase 2
Details
Lead Sponsor:
Stanford University
Collaborators:
Food Allergy Research & Education National Institute of Allergy and Infectious Diseases (NIAID)