drugset / Trial / NCT04045301
Omalizumab to Accelerate a Symptom-driven Multi-food OIT
Phase 2
Active not recruiting
90 enrolled
Philippe Bégin
Centre de recherche du Centre hospitalier universitaire de Sherbrooke · collabCentre hospitalier de l'Université de Montréal (CHUM) · collabThe Hospital for Sick Children · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | 8 mg/kg | — |
| Subject | Omalizumab | Monoclonal antibody | 16 mg/kg | — |