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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase IV, open-label, single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA.

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

Research shows that Omalizumab, originally approved for allergic asthma, helps some people with food allergies tolerate higher amounts of allergens and reduces symptoms like asthma and skin reactions. In a study, all 22 patients with food allergies experienced significant improvement in symptoms after using 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 add-on to make oral immunotherapy more effective. ^{1 2 5 8 9}

Eligibility Criteria

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 have a condition like nasal polyps or cystic fibrosis that affects my FeNO levels.

Timeline

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

Treatment Details

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.

Participant Groups

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+

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]