Omalizumab to Accelerate a Symptom-driven Multi-food OIT

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

November 11, 2019

Primary Completion Date

December 31, 2025

Study Completion Date

March 31, 2026

Conditions
Food IgE-mediated AllergyImmunotherapyOmalizumabPhysiological Effects of Drugs
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

OTHER

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.

Trial Locations (3)

M5G 1X8

The Hospital for Sick Children, Toronto

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

J1H 5N4

CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS), Sherbrooke

All Listed Sponsors
collaborator

The Hospital for Sick Children

OTHER

collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

lead

Philippe Bégin

OTHER