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Omalizumab to Accelerate a Symptom-driven Multi-food OIT — BOOM  

Immunotherapy Clinical Trial

Official title:
A 15 Months, Double-Blind, Randomized Controlled Trial Comparing 20 Weeks of Two Dosages of Omalizumab to Placebo to Accelerate a Symptom-driven Oral Immunotherapy Schedule in Subjects Aged 6 to 25 Years With Multiple Food Allergies

Clinical Trial 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.

Clinical Trial Description

This is a phase 2b, multi-center randomized controlled trial comparing 2 doses of omalizumab to placebo in subjects 6 to 25 years old with multiple food allergies undergoing a symptom-driven multi-food OIT protocol. Subjects will undergo a screening period involving a DBPCFC to a mix of three allergens which will determine their eligibility and eliciting dose. Eligible subjects will be randomized to one of 2 omalizumab dosages or placebo at a ratio of 2:2:1 for a total period of 20 weeks. They will undergo initial food escalation (IFE) to determine their starting food treatment mix dose for three simultaneous food allergens after a pre-treatment period of 8 weeks with the study drug. Subjects will undergo up-dosing OIT visits at the clinic every two weeks, until a maintenance dose of 1500mg of protein (500mg per food) is reached (primary endpoint). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04045301
Study type Interventional
Source St. Justine's Hospital
Contact Marie-Christine Auclair, B.Sc.N.
Phone (514) 345-4931
Email marie-christine.auclair.hsj@ssss.gouv.qc.ca
Status Recruiting
Phase Phase 2
Start date November 11, 2019
Completion date March 2025
View Details
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