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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether omalizumab, administered as injections every two weeks for 24 weeks, can safely help individuals with food allergies tolerate the foods they are allergic to. Researchers aim to determine if participants can incorporate these foods into their diet after taking omalizumab twice a week for an additional 8 weeks. Suitable candidates for this trial are individuals aged 1 to 55 with allergies to specific foods like peanuts, cashews, or eggs, and who have a history of allergic reactions to small amounts of these foods. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant allergy research.

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.

Is there any evidence suggesting that omalizumab is likely to be safe for humans?

Research has shown that omalizumab is generally safe for people with food allergies. In earlier studies, the most common side effects were mild, such as injection site reactions and fever. Importantly, these studies found no new serious reactions.

Omalizumab, also known as Xolair, has FDA approval to help reduce allergic reactions, including severe ones like anaphylaxis, a fast and serious allergic reaction. This approval indicates the medication's safety in controlled settings.

Overall, the treatment has shown promise in helping people manage food allergens better, with a strong safety record in past research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for food allergy?

Omalizumab is unique because it targets IgE, an antibody involved in allergic reactions, which is different from most food allergy treatments that focus on avoiding allergens. Researchers are excited because omalizumab could potentially reduce the body's sensitivity to allergens, allowing people with food allergies more freedom in their diets. This biologic treatment offers a new approach by potentially altering the immune system's response, rather than just managing symptoms.

What evidence suggests that omalizumab might be an effective treatment for food allergies?

Research has shown that omalizumab can help people with food allergies by increasing their ability to tolerate allergens like peanuts. One study found that 68% of patients who received omalizumab were protected from moderate to severe allergic reactions, compared to only 5% of those who received a placebo (a harmless pill with no active medicine). Another study found that omalizumab worked better than oral immunotherapy and caused fewer side effects. Additionally, 36% of participants could handle larger amounts of peanut protein after taking omalizumab for a longer period. These findings suggest that omalizumab may help people with food allergies tolerate allergens better, making it a promising option for those affected. Participants in this trial will receive omalizumab, as it is the sole treatment being studied. ^{1 4 6 7 8}

Who Is on the Research Team?

Robert Wood, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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, 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]

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]

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]

Citations

1. xolair.com xolair.com/food-allergies/results-with-xolair/clinical-trial-results.html

Clinical trial results for people 1 year of age and older XOLAIR protected 68% of patients vs 5% of patients treated with placebo from moderate to severe allergic symptoms. This means they did not have moderate to ...

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.

3. xolairhcp.com xolairhcp.com/food-allergies/efficacy/clinical-trial-results.html

IgE-Mediated Food Allergy Clinical Trial Results | HCP XOLAIR protected 68% of patients vs 5% of patients treated with placebo by reducing moderate to severe allergic reactions to food.

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

Omalizumab treats multi-food allergy better than oral ... Thirty-six percent of study participants who received an extended course of omalizumab could tolerate 2 grams or more of peanut protein, or ...

6. xolairhcp.com xolairhcp.com/food-allergies/side-effects/side-effects.html

IgE-Mediated Food Allergies Treatment Side Effects & ... Safety data were consistent with XOLAIR clinical trials in other indications, with no new adverse reactions observed4; No patients experienced anaphylaxis ...

7. xolair.com xolair.com/food-allergies/about-xolair/important-safety-information.html

XOLAIR Side Effects | Food Allergy The most common side effects of XOLAIR in people with food allergy: injection site reactions and fever. These are not all the possible side effects of XOLAIR. ...

8. gene.com gene.com/download/pdf/Genentech_Xolair-Product-Fact-Sheet.pdf

XOLAIR IN FOOD ALLERGY The U.S. Food and Drug Administration (FDA) has approved Xolair®. (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur ...