drugset / Trial / NCT06618963

Effect of Omalizumab in the Skin of Food Allergy Patients

NCT06618963

Phase 4 Recruiting 40 enrolled National Jewish Health Roche-Genentech · collab
Non-randomizedParallel-groupOpen-labelBasic science

Summary

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.

Timeline

Start
2024-10-01
Primary completion
2026-09
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Omalizumab Monoclonal antibody

Indications