Omalizumab for Food Allergy

Overseen By Robert Wood, MD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: Corticosteroids, Antidepressants, Beta-blockers, others

Disqualifiers: Severe asthma, Anaphylaxis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 28

Duration: 24 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

In this project, the investigators would like to learn if 24 weeks (about 5 and a half months) of omalizumab injections, given every 2 weeks, will be safe and effective for food allergic people who have a total immunoglobulin E (IgE) above the current FDA approved dosing regimen enabling a person to increase tolerance to the food(s) that the person is allergic to. The investigators would also like to learn if participants who demonstrate increased tolerance to food after 24 weeks of omalizumab, can introduce the food into the diet utilizing an additional 8 weeks (about 2 months) of twice weekly omalizumab injections.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, β-blockers, and antihistamines for specific periods. If you are on these medications, you may need to discontinue them to participate.

What data supports the effectiveness of the drug Omalizumab for food allergy?

Research shows that Omalizumab, originally approved for allergic asthma, can help people with food allergies tolerate higher amounts of allergens and reduce symptoms like asthma, skin reactions, and anaphylaxis. In a study, all 22 patients with food allergies experienced significant improvement in symptoms after treatment with Omalizumab. ^{1 2 3 4 5}

Is omalizumab safe for treating food allergies?

Omalizumab has been used safely in patients with asthma and food allergies, but there is a risk of anaphylaxis (a severe allergic reaction) that is noted in its prescribing information. Some patients have experienced skin reactions, but overall, it has shown to improve allergy symptoms in many cases. ^{2 3 6 7 8}

How does the drug omalizumab differ from other treatments for food allergy?

Omalizumab is unique because it is a monoclonal antibody that targets IgE (a type of antibody involved in allergic reactions), reducing allergic responses by decreasing IgE levels and receptor expression. Unlike standard treatments that focus on avoiding allergens, omalizumab can help patients tolerate higher amounts of allergens and is used as an adjunct to make oral immunotherapy more effective. ^{1 2 5 8 9}

Research Team

Robert Wood, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for individuals with food allergies and high levels of total IgE, which are antibodies linked to allergic reactions. Participants should be able to commit to receiving omalizumab injections every two weeks for about 5 and a half months, with the goal of increasing tolerance to allergenic foods.

Inclusion Criteria

A positive prick skin test (PST) with a wheal ≥ 6 mm to at least one of the relevant foods (peanut, cashew, walnut, egg, milk, or wheat)

Positive food-specific IgE (≥2.0 kilo units of allergen-specific IgE per liter (kUA/L)) to at least one of the study specific foods

I am between 1 and 55 years old.

Exclusion Criteria

I have had a stomach or intestinal condition related to eosinophils in the last 3 years.

I am currently taking steroids, antidepressants, or β-blockers.

Clinically significant laboratory abnormalities at screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive omalizumab injections every 2 weeks for 24 weeks to increase food tolerance

24 weeks

12 visits (in-person)

Diet Introduction

Participants who demonstrate increased tolerance introduce the food into their diet with additional omalizumab injections

8 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Omalizumab

Trial Overview The study tests if omalizumab injections given bi-weekly over 24 weeks can safely increase food allergy sufferers' tolerance. After this period, there's an additional phase where participants may try eating the foods they're allergic to while continuing the treatment for another 8 weeks.

Participant Groups

Group I: Treatment with omalizumab Experimental Treatment 1 Intervention

This is an open label study of omalizumab with no placebo. Participants who meet study inclusion criteria and are enrolled in the study will receive omalizumab. The dose of omalizumab will be based on participant's weight.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Findings from Research

Omalizumab, an FDA-approved monoclonal antibody for allergic asthma, works by binding to IgE, which may also help patients with food allergies by allowing them to tolerate higher amounts of allergens during treatment.

In clinical trials, omalizumab has shown promise as an adjunct therapy in food allergy immunotherapy, enabling patients to receive higher doses more quickly, but further large-scale studies are needed to confirm its efficacy and identify the best candidates for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of omalizumab in the treatment of food allergy and anaphylaxis. Lieberman, JA., Chehade, M.[2021]

In a pilot study involving 22 patients with moderate to severe asthma and IgE-mediated food allergies, omalizumab treatment led to significant improvements in allergy symptoms upon reexposure to sensitized foods, with all patients reporting clinical benefits.

By the sixth dose of omalizumab, patients experienced reductions in various allergy-related symptoms, including asthma, atopic dermatitis, urticaria, rhinosinusitis, and even severe reactions like angioedema and anaphylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of omalizumab in patients with food allergy. Rafi, A., Do, LT., Katz, R., et al.[2016]

In a study of 15 children with severe asthma, treatment with omalizumab significantly increased food allergen thresholds, allowing 70.4% of subjects to tolerate previously problematic foods without oral immunotherapy.

The quality of life for patients improved markedly, as indicated by a significant increase in Pediatric Quality of Life Inventory scores, alongside a dramatic reduction in allergic reactions from 47 to just 2 over the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Omalizumab on Food Allergy in Patients Treated for Asthma: A Real-Life Study. Fiocchi, A., Artesani, MC., Riccardi, C., et al.[2020]

In a study of 23 severely peanut allergic adolescents treated with omalizumab for 8 weeks, individualized dosing based on basophil allergen threshold sensitivity (CD-sens) effectively suppressed allergic reactions, with most patients experiencing no or only mild symptoms during peanut challenges.

The findings suggest that higher baseline CD-sens values and specific IgE-antibody ratios can predict the need for increased omalizumab doses, indicating a tailored approach to treatment may enhance safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individually dosed omalizumab: an effective treatment for severe peanut allergy. Brandström, J., Vetander, M., Lilja, G., et al.[2018]

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]

A 51-year-old woman with severe asthma and multiple food allergies experienced a complete disappearance of her food allergy symptoms after 6 years of treatment with omalizumab, suggesting its potential efficacy in managing food allergies in adults.

After discontinuing omalizumab, the patient experienced a return of food allergy symptoms, which improved again upon readministration, indicating that omalizumab may help induce remission of food allergies while also controlling asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment of a patient with adult food allergy and severe asthma using omalizumab. Nishie, M., Masaki, K., Okuzumi, S., et al.[2021]

A review of 124 cases of anaphylaxis linked to omalizumab in asthma patients revealed that symptoms often appeared more than 2 hours after administration, which is unusual for typical anaphylactic reactions.

The cases showed a protracted progression of symptoms, with signs of anaphylaxis developing over several hours, indicating that healthcare providers should be aware of this delayed response when administering omalizumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma. Limb, SL., Starke, PR., Lee, CE., et al.[2022]

Omalizumab effectively controlled symptoms of severe allergic asthma, allergic rhinitis, and rhinosinusitis in children, demonstrating its efficacy as an add-on therapy for those with uncontrolled conditions.

In cases of severe food allergy, omalizumab aided in the successful oral desensitization process when used alongside oral immunotherapy, suggesting it may enhance treatment outcomes for food allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab in children with severe allergic disease: a case series. Crisafulli, G., Caminiti, L., Chiera, F., 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]

References

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

Use of omalizumab in the treatment of food allergy and anaphylaxis. [2021]

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

Effects of omalizumab in patients with food allergy. [2016]

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

Impact of Omalizumab on Food Allergy in Patients Treated for Asthma: A Real-Life Study. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Individually dosed omalizumab: an effective treatment for severe peanut allergy. [2018]

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

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Successful treatment of a patient with adult food allergy and severe asthma using omalizumab. [2021]

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

Delayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Omalizumab in children with severe allergic disease: a case series. [2020]

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

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