drugset / Trial / NCT03181009

Multi OIT to Test Immune Markers After Minimum Maintenance Dose

NCT03181009

RandomizedParallel-groupDouble-blindTreatment

Summary

Few studies have been conducted to optimize safety of multiple food allergen oral immunotherapy (OIT) in conjunction with Omalizumab as well as to identify the immunological mechanism(s) underlying any long-lasting effects of OIT. To address these issues in the field of food allergy research, we have designed this study to test whether: 1) Omalizumab improves the safety of multiple food allergen OIT in subjects with multi food allergies, 2) Omalizumab treatment with multiple food allergen OIT is associated with the ability to use a lower maintenance dose of each food allergens in the OIT regimen, particularly in younger subjects with food allergies.

Timeline

Start
2017-07-31
Primary completion
2018-12-01
Completion
2019-01-30

Drugs

EvaluationDrugModalityDoseRoute
Background Omalizumab Monoclonal antibody 75 mg
Background Omalizumab Monoclonal antibody 150 mg

Indications