Effect of Omalizumab in the Skin of Food Allergy Patients

The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab. If there is a comparison group: Researchers will compare non-food allergic participants (who do not receive omalizumab) to see if they experience skin barrier abnormalities. All food allergic participants will receive 4 months of Omalizumab treatment as well as two Oral Food Challenges. Participants will all undergo skin barrier assessments.

NCT Number	NCT06618963
Lead Sponsor	National Jewish Health Collaborators: Roche-Genentech
Conditions	Food Allergy, Food Allergy in Children
Enrollment	40 participants
Start Date	2024-10-01
Primary Completion	2026-09 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-05-02