drugset / Trial / NCT07845552

Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy

NCT07845552 ↗

Phase 4 Not yet recruiting 20 enrolled Johns Hopkins University
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-10
Primary completion
2028-10
Completion
2028-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody 75 mg Subcutaneous
Subject Omalizumab Monoclonal antibody 600 mg Subcutaneous

Indications