90
Participants
Start Date
November 11, 2019
Primary Completion Date
December 31, 2025
Study Completion Date
March 31, 2026
Omalizumab 16mg/kg
Participants will receive omalizumab 16 mg/kg monthly doses for 12 weeks, followed by omalizumab 8 mg/kg monthly for 4 weeks and then omalizumab 4 mg/kg monthly for 4 weeks, for a total of 20 weeks including a taper period.
Omalizumab 8mg/kg
Participants will receive omalizumab 8 mg/kg monthly doses for 12 weeks, followed by omalizumab 4 mg/kg monthly for 4 weeks and then omalizumab 2 mg/kg monthly for 4 weeks, for a total of 20 weeks including a taper period.
Placebo
Participants will receive placebo for 8 weeks prior to the initiation of oral immunotherapy and 12 weeks after for a total of 20 weeks including a taper period.
Multi-food oral immunotherapy (OIT)
Multi-food oral immunotherapy will be conducted to a mix of three foods. It will be started 8 weeks after study drug with an initial food escalation. Participants will undergo biweekly increase until they tolerate a maintenance dose of 1500 mg (500 mg per food) of food protein.
The Hospital for Sick Children, Toronto
Centre Hospitalier Universitaire Sainte-Justine, Montreal
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS), Sherbrooke
The Hospital for Sick Children
OTHER
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
OTHER
Philippe Bégin
OTHER