NCT04045301

Omalizumab to Accelerate a Symptom-driven Multi-food OIT

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Philippe Bégin · Academic / Other
• Sex: All
• Age: 6 Years – 25 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Food IgE-mediated Allergy
• Immunotherapy
• Omalizumab
• Physiological Effects of Drugs

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-11
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2019-08-05
• Last updated: 2024-11-27

Locations

3 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study