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

Phase 2

Recruiting

Led By Philippe Bégin, MD, PhD

Research Sponsored by Philippe Bégin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Positive DBPCFC to treatment food mix with an eliciting dose ≤ 300 mg of total food protein

Be younger than 65 years old

Must not have

Active or past confirmed eosinophilic oesophagitis

Subject/parent unwillingness to comply with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at any time during the 12-month oit phase

Summary

This trial will study whether omalizumab can help people with multiple food allergies complete an oral immunotherapy protocol more quickly.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Omalizumab may cause side effects such as injection site reactions, headaches, fatigue, joint pain, earache, hair loss, dizziness; rare but serious risks include anaphylaxis and heart-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with eosinophilic esophagitis.

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I am willing to follow all study requirements.

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I am taking beta-blockers or ACE inhibitors.

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

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I have severe asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at any time during the 12-month oit phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at any time during the 12-month oit phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and at any time during the 12-month oit phase for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol.

Secondary study objectives

Average up-dosing speed while on study drug.

Change in reactivity threshold to food treatment mix after pre-treatment with study drug.

Mean cumulative function of allergic adverse events attributable to food dosing throughout the trial.

+1 more

Trial Design

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.

0 / 6Eligibility criteria met