Omalizumab-Assisted Oral Immunotherapy for Food Allergies

(BOOM Trial)

Recruiting at 4 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

90 Participants Needed

Trial Summary

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.

What data supports the effectiveness of this treatment for food allergies?

Research shows that using omalizumab (a drug that helps reduce allergic reactions) along with oral immunotherapy (a treatment where small amounts of the allergen are given to build tolerance) can help people with multiple food allergies become less sensitive to those foods. Studies have demonstrated that this combination can be safe and effective, even for those with severe allergies. ^{1 2 3 4 5}

Is Omalizumab-Assisted Oral Immunotherapy for Food Allergies safe for humans?

Studies have shown that using omalizumab with oral immunotherapy (OIT) for food allergies is generally safe and well-tolerated in humans, even for multiple food allergies. However, there is a risk of adverse reactions, including severe allergic reactions (anaphylaxis), which is a concern for OIT in general. ^{1 2 3 5 6}

How is the treatment Omalizumab-Assisted Oral Immunotherapy for Food Allergies different from other treatments?

This treatment is unique because it combines omalizumab, a medication that helps reduce allergic reactions, with oral immunotherapy (OIT) to rapidly desensitize patients to multiple food allergens at once, which is not commonly done with traditional single-food OIT. ^{1 2 7 8 9}

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.

Research Team

Philippe Bégin, MD, PhD

Principal Investigator

St. Justine's Hospital

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Omalizumab as an adjuvant in food allergen immunotherapy. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Anti-IgE treatment with oral immunotherapy in multifood allergic participants: a double-blind, randomised, controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Omalizumab in IgE-Mediated Food Allergy: A Systematic Review and Meta-Analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Long-Term Outcome of Peanut Oral Immunotherapy Facilitated Initially by Omalizumab. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Food Oral Immunotherapy: What We Know, and What We Need to Learn. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Community opinions regarding oral immunotherapy for food allergies. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of Multifood Oral Immunotherapy in Children Aged 1 to 18 Years at an Academic Pediatric Clinic. [2023]

9. England 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. [2022]