Omalizumab-Assisted Oral Immunotherapy for Food Allergies (BOOM Trial)

Palo Alto (17 mi)

Overseen byPhilippe Bégin, MD, PhD

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Philippe Bégin

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals aged 6 to 25 with a history of IgE-mediated allergy to at least three specific foods and positive skin and blood tests indicating severe allergies. They must avoid these allergens strictly, not have used immunotherapy or certain drugs in the past year, and cannot be pregnant or lactating.

Inclusion Criteria

I reacted to a food allergy test with a small amount of the allergen.

Exclusion Criteria

I have been diagnosed with eosinophilic esophagitis.

I am willing to follow all study requirements.

I am taking beta-blockers or ACE inhibitors.

I am allergic to ingredients in the placebo mix that can't be changed.

I have severe asthma.

Treatment Details

The study is testing how well omalizumab works in different doses (16mg/kg and 8mg/kg) compared to a placebo when given before starting oral immunotherapy for multiple food allergies. It aims to see if it can shorten the time needed to reach maintenance dose of OIT.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Omalizumab 8 mg/kgExperimental Treatment2 Interventions

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.

Group II: Omalizumab 16 mg/kgExperimental Treatment2 Interventions

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.

Group III: PlaceboPlacebo Group2 Interventions

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.