Omalizumab-Assisted Oral Immunotherapy for Food Allergies

(BOOM Trial)

Not currently recruiting at 5 trial locations

Overseen By Chantal Légaré

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Philippe Bégin

Must not be taking: Immunosuppressants, Beta-blockers, ACE inhibitors

Disqualifiers: Severe asthma, Eosinophilic oesophagitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if omalizumab, an allergy medication, can help individuals with food allergies begin and maintain multi-food oral immunotherapy (OIT) more quickly. The study will compare two different doses of omalizumab to a placebo, focusing on allergies to three different foods simultaneously. It targets individuals aged 6 to 25 who are allergic to at least three foods, such as peanuts, milk, or eggs, and strictly avoid them. Participants must be willing to consume controlled doses of these allergens as part of the treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in allergy treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking anti-histamine medications before study procedures and you cannot be on beta-blockers or ACE inhibitors. If you are using immunosuppressive drugs or certain other treatments, you must have stopped them at least a year before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that omalizumab is generally safe for people. Studies have found it effective and causing fewer side effects than oral immunotherapy for treating food allergies. One study found that omalizumab helped individuals tolerate more of a food allergen before reacting, with fewer negative effects compared to oral immunotherapy alone. This suggests that omalizumab is safe for treating multiple food allergies, even when combined with oral immunotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of omalizumab in combination with multi-food oral immunotherapy (OIT) for food allergies because it offers a unique approach compared to traditional treatments like strict dietary avoidance and emergency epinephrine. Omalizumab is an antibody that targets immunoglobulin E (IgE), a key player in allergic reactions, potentially reducing the severity of allergic responses. This dual approach, using omalizumab to stabilize the immune system and OIT to gradually build tolerance to multiple foods, could significantly enhance safety and effectiveness, potentially allowing patients to safely consume foods that once triggered severe allergic reactions. This combination could pave the way for more comprehensive and long-term solutions for those with multiple food allergies.

What evidence suggests that this trial's treatments could be effective for food allergies?

In this trial, participants will receive either omalizumab (Xolair) or a placebo, alongside multi-food oral immunotherapy (OIT). Research has shown that omalizumab effectively treats multiple food allergies. Studies have found it works better than OIT alone, helping individuals tolerate more food allergens. One study discovered that omalizumab increases the amount of allergens a person can handle without reacting. It has demonstrated greater effectiveness with fewer side effects compared to OIT. These findings suggest that omalizumab could significantly enhance the lives of people with food allergies. ^{1 2 3 4 6}

Who Is on the Research Team?

Philippe Bégin, MD, PhD

Principal Investigator

St. Justine's Hospital

Are You a Good Fit for This Trial?

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

Positive SPT with a largest wheal diameter ≥ 6 mm to all three foods

Food-specific IgE level greater than 15 kU/L for all three foods

History of IgE-mediated allergy to at least three foods within the following list: peanut, milk, egg, wheat, oat, soy, barley, rye, buckwheat, hazelnut, pecan, cashew, pistachio, almond, walnut and sesame

Exclusion Criteria

I have been diagnosed with eosinophilic esophagitis.

Pregnancy or lactation for the duration of the study

I am willing to follow all study requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-treatment

Participants receive omalizumab or placebo for 8 weeks before starting oral immunotherapy

8 weeks

Monthly visits (in-person)

Treatment

Participants undergo multi-food oral immunotherapy with up-dosing visits every two weeks

20 weeks

Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Multi-food oral immunotherapy (OIT)
• Omalizumab

Trial Overview

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.

How Is the Trial Designed?

Group I: Omalizumab 8 mg/kg Experimental Treatment 2 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/kg Experimental Treatment 2 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: Placebo Placebo Group 2 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.

Who Is Running the Clinical Trial?

Philippe Bégin

Lead Sponsor

Trials

3

Recruited

600+

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Trials

64

Recruited

33,600+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

Published Research Related to This Trial

Oral immunotherapy (OIT) for food allergies carries a risk of adverse reactions, including anaphylaxis, which is a significant barrier to its clinical use.

There is a need for an international consensus on safety reporting in OIT studies to better understand its safety profile and develop safer, individualized treatment pathways for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Food Oral Immunotherapy: What We Know, and What We Need to Learn. Vázquez-Cortés, S., Jaqueti, P., Arasi, S., et al.[2020]

Omalizumab (OMA) significantly increases the tolerated dose of multiple foods in patients with IgE-mediated food allergies, improving quality of life and reducing allergic reactions, based on a review of 36 studies.

When used as an adjunct to oral immunotherapy (OMA+OIT), OMA enhances desensitization and allows for higher maintenance doses, with no major safety concerns reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab in IgE-Mediated Food Allergy: A Systematic Review and Meta-Analysis. Zuberbier, T., Wood, RA., Bindslev-Jensen, C., et al.[2023]

Oral immunotherapy (OIT) is being developed as a patient-centered approach to treat IgE-mediated food allergies, with 38 recommendations created based on evidence and ethical considerations from a review of 162 articles and consultations with 85 individuals.

The guidelines emphasize shared responsibility between patients and healthcare providers, promoting patient empowerment and personalized treatment plans, while also addressing the need for equitable access and sustainability in food allergy care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CSACI guidelines for the ethical, evidence-based and patient-oriented clinical practice of oral immunotherapy in IgE-mediated food allergy. Bégin, P., Chan, ES., Kim, H., et al.[2022]

Omalizumab, when used alongside food allergen oral immunotherapy (OIT) for allergies like milk and peanuts, can help patients reach maintenance dosing faster and reduce adverse events, although serious side effects can still occur.

There is a risk of increased allergic reactivity after stopping omalizumab, and many patients have discontinued treatment, highlighting the need for more research to improve safety and identify the best candidates for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab as an adjuvant in food allergen immunotherapy. Dantzer, JA., Wood, RA.[2021]

In a study of 151 pediatric patients undergoing oral immunotherapy (OIT), 67.9% of those on single-food OIT and 86% of those on multifood OIT reached maintenance doses, indicating that both approaches are effective in desensitizing patients to food allergens.

The safety profile of OIT was favorable, with low rates of severe reactions: only 10.9% of initial dose escalations failed, and serious adverse events like epinephrine use and hospital admissions were very rare, suggesting that OIT can be safely implemented in an outpatient setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Multifood Oral Immunotherapy in Children Aged 1 to 18 Years at an Academic Pediatric Clinic. Nguyen, K., Lewis, MO., Hanna, E., et al.[2023]

Citations

1.

nih.gov

nih.gov/news-events/news-releases/omalizumab-treats-multi-food-allergy-better-oral-immunotherapy

Omalizumab treats multi-food allergy better than oral ...

A clinical trial has found that the medication omalizumab, marketed as Xolair, treated multi-food allergy more effectively than oral immunotherapy (OIT).

2.

roche.com

roche.com/media/releases/med-cor-2025-03-02

Phase III study shows Xolair may be more effective with ...

Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies. March 01 ...

3.

aaaai.org

aaaai.org/about/news/news/2025/omalizumab

Omalizumab Is Superior to Oral Immunotherapy Food ...

Food allergy treatment with omalizumab resulted in better outcomes with fewer adverse effects than oral immunotherapy according to new research.

4.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2312382

Omalizumab for the Treatment of Multiple Food Allergies

Omalizumab treatment for 16 weeks was superior to placebo in increasing the reaction threshold for peanut and other common food allergens.

5.

gene.com

gene.com/media/press-releases/15054/2025-03-02/phase-iii-study-shows-xolair-may-be-more

Genentech: Press Releases | Sunday, Mar 2, 2025

In the first head-to-head trial comparing Xolair to OIT, the study met its primary endpoint showing 36% of food allergy patients treated with ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03881696

Study Details | NCT03881696 | Omalizumab as ...

This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut ...