Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels

In this project, the investigators would like to learn if 24 weeks (about 5 and a half months) of omalizumab injections, given every 2 weeks, will be safe and effective for food allergic people who have a total immunoglobulin E (IgE) above the current FDA approved dosing regimen enabling a person to increase tolerance to the food(s) that the person is allergic to. The investigators would also like to learn if participants who demonstrate increased tolerance to food after 24 weeks of omalizumab, can introduce the food into the diet utilizing an additional 8 weeks (about 2 months) of twice weekly omalizumab injections.

NCT Number	NCT06934200
Lead Sponsor	Johns Hopkins University Collaborators: Genentech, Inc.
Conditions	Food Hypersensitivity
Enrollment	32 participants
Start Date	2025-05-19
Primary Completion	2027-04-15 (estimated)
Study Completion	2027-10-15 (estimated)
Updated on ClinicalTrials.gov	2026-06-08