Omalizumab to Accelerate a Symptom-driven Multi-food OIT

Phase 2

Active, not recruiting

• Conditions: Immunotherapy; Omalizumab; Physiological Effects of Drugs; Food IgE-mediated Allergy
• Interventions: Biological: Omalizumab 8mg/kg; Biological: Omalizumab 16mg/kg; Biological: Placebo; Other: Multi-food oral immunotherapy (OIT)

• Registration Number: NCT04045301
• Lead Sponsor: Philippe Bégin

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-05
• Study Start: 2019-11-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omalizumab 8 mg/kg	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. Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
Omalizumab 16 mg/kg	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. Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
Omalizumab 16 mg/kg	Multi-food oral immunotherapy (OIT)	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. Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
Omalizumab 8 mg/kg	Multi-food oral immunotherapy (OIT)	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. Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
Placebo	Placebo	Participants will receive placebo doses for 20 weeks. The doses will be injected every 2 or 4 weeks depending on the weight of the participant. Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
Placebo	Multi-food oral immunotherapy (OIT)	Participants will receive placebo doses for 20 weeks. The doses will be injected every 2 or 4 weeks depending on the weight of the participant. Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol.	Assessed up to 52 weeks after IFE	Time from IFE to target multi-food protein maintenance dose of 1500 mg of total food protein

Secondary Outcome Measures

Name	Time	Method
Average up-dosing speed while on study drug.	From week 0 to week 12 post IFE	Average of (log of escalation %)/(days since last escalation) for all escalation visits while on study drug
Change in reactivity threshold to food treatment mix after pre-treatment with study drug.	Measured 8 weeks after starting investigational product	Measured as the amount of food allergen eliciting an objective allergic reaction on double-blinded oral food challenge or initial food escalation.
Mean cumulative function of allergic adverse events attributable to food dosing throughout the trial.	For one year following IFE	AEs will be captured using the daily dosing diary throughout the trial, including during maintenance. Any systemic reaction having occurred since the last visit will be reviewed and graded by the investigator according to the CoFAR grading system.
Rate of treatment failure	At any time during the 12-month OIT phase	Subject which stop daily ingestion of food treatment mix, prior to achieving study maintenance dose, for a period of 14 days or more

Trial Locations

Locations (3)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Centre Hospitalier Universitaire Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada

CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS); 🇨🇦 Sherbrooke, Quebec, Canada