Omalizumab for Food Allergy

Overseen By Claudia Eisenlohr, MIB

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: AAADRS Clinical Research Center

Must not be taking: Inhaled steroids, Biologics

Disqualifiers: Asthma, Nasal polyps, Cystic fibrosis, 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: 2

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests omalizumab, a medication, to determine its effectiveness for people with food allergies. The researchers aim to assess whether this treatment affects a lung marker called FeNO, which relates to allergies. Participants should have a known allergy to foods such as peanuts, milk, eggs, or certain nuts and should not have asthma requiring daily medication. This study may suit those struggling with food allergies who wish to explore new treatment options. As a Phase 4 trial, omalizumab is already FDA-approved and proven effective, offering participants the opportunity to benefit from a well-established treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before participating. Specifically, you must not use systemic steroids, leukotriene modifiers, or nasal steroids within 4 weeks of the baseline, and you must not have used antibiotics within 2 weeks of the baseline. Additionally, you cannot have used biologics within five half-lives of screening.

What is the safety track record for this treatment?

Research has shown that omalizumab is generally safe for people with food allergies. One study found that it helped individuals consume more of a food before experiencing an allergic reaction, with no new serious side effects identified. Another report indicated that 68% of patients experienced fewer allergic symptoms with omalizumab, compared to only 5% with a placebo. Even after administering over 10,000 doses in Italy, no serious allergic reactions were reported. This suggests that omalizumab is well-tolerated and has a strong safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Omalizumab is unique because it targets IgE antibodies, which play a key role in allergic reactions, including food allergies. Unlike most current treatments for food allergies that focus on avoiding allergens or managing symptoms after exposure, omalizumab works by reducing the body's sensitivity to allergens from the inside out. Researchers are excited about this treatment because it offers a proactive approach, potentially allowing patients to tolerate foods that previously triggered severe allergic reactions. This could significantly improve the quality of life for individuals with food allergies.

What is the effectiveness track record for Omalizumab in treating food allergies?

Research has shown that omalizumab, the treatment under study in this trial, can help manage multiple food allergies. One study demonstrated that it improved tolerance to peanuts and other common food allergens by increasing the amount participants could safely consume. Another study found that 68% of those taking omalizumab were protected from moderate to severe allergic reactions, compared to only 5% who received a placebo (a harmless pill with no active medicine). Some participants could even consume up to 2 grams of peanut protein after using omalizumab for a while. This treatment is already approved for other conditions, demonstrating its effectiveness in similar situations. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with multiple food allergies. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may need to have a history of allergic reactions to foods.

Inclusion Criteria

Patients must be able and willing to provide written informed consent from patient and parent or guardian and to comply with the study protocol

Documented history of food allergy to peanut, milk, egg, and tree nuts (Walnut/Pecan, Cashew/Pistachio, Almond, Hazelnut, Brazil nut) based on SPT performed at baseline visit

I am 6 years old or older.

Exclusion Criteria

I haven't taken biologic medication within its last five half-lives before screening.

I haven't taken any antibiotics by mouth or injection in the last 2 weeks.

I currently smoke or have a history of heavy smoking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Omalizumab treatment and are monitored for hypersensitivity reactions

52 weeks

Every 2 weeks for 16 weeks, then every 2 or 4 weeks for 36 weeks

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 is testing Omalizumab (OMA), an allergy medication, to see if it changes levels of FeNO—a marker that could indicate how well the treatment works for those with multiple food allergies.

How Is the Trial Designed?

Group I: Open Label Injection of Omalizumab Experimental Treatment 1 Intervention

Omalizumab dose and frequency based on baseline patient weight and total IgE

Who Is Running the Clinical Trial?

AAADRS Clinical Research Center

Lead Sponsor

Trials

3

Recruited

70+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1.

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.

2.

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 ...

3.

xolair.com

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

Clinical Trials | XOLAIR® (omalizumab) for Food Allergy

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 ...

4.

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.

5.

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.

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12322909/

Omalizumab in food allergy: Risks and benefits - PMC

A real-life analysis from Italy provided reassuring results of no systemic reactions in >10,000 doses administered. Therefore, although hypersensitivity ...