drugset / Trial / NCT04045301

Omalizumab to Accelerate a Symptom-driven Multi-food OIT

NCT04045301

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will determine the dose-related efficacy of a 20-week treatment of omalizumab started 8 weeks before the onset of a symptom-driven multi-food oral immunotherapy (OIT) protocol at decreasing time to OIT maintenance dose. Two dosages of omalizumab will be compared to placebo during an oral immunotherapy protocol for three simultaneous food allergens.

Timeline

Start
2019-11-11
Primary completion
2025-12
Completion
2026-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody 8 mg/kg
Subject Omalizumab Monoclonal antibody 16 mg/kg

Indications