Johns Hopkins University
The goal of this clinical trial is to learn how quickly omalizumab begins to work in people with food allergy. The main question it aims to answer is: * Does omalizumab begin to work as early as 2 to 4 weeks after after starting treatment in people with food allergy? Researchers will compare each participant's food challenge results at baseline before starting omalizumab, 2 to 4 weeks after starting omalizumab, and 4 to 6 months after starting omalizumab treatment. Participants will: * Have a baseline food challenge before starting omalizumab. * Start omalizumab treatment as prescribed by the participant's doctor as part of regular clinical care. * Have food challenges 2 to 4 weeks after starting omalizumab and again 4 to 6 months after starting omalizumab. * Have skin prick testing and blood tests at study visits.
Inclusion Criteria: * Age 1 to 30 years. * Patients with diagnosed food allergy to at least one of the following foods (milk, egg, wheat, peanut, cashew, or walnut) who were prescribed omalizumab for food allergy in the clinical setting at the Johns Hopkins pediatric or adult allergy clinic. * Positive food-specific IgE (≥2.0 kUA/L) to the relevant food OR a positive skin-prick test with a wheal ≥4 mm larger than the saline control. * Positive open oral food challenge at baseline screening evaluation to the relevant food with dose-limiting symptoms at a single dose of ≤1000 mg (cumulative dos…
Prior to starting omalizumab, participants will undergo a baseline oral food challenge. Participants will then initiate omalizumab treatment as prescribed by their doctor as part of routine clinical care. After 2 to 4 weeks of treatment (following one to two doses of omalizumab), participants will undergo a first post-treatment oral food challenge to assess treatment response. After 4 to 6 months of omalizumab treatment, participants will undergo a second post-treatment oral food challenge. The study will conclude following the second post-treatment oral food challenge.
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