Omalizumab for Food Allergy

Overseen By Lead Coordinator

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: National Jewish Health

Must be taking: Omalizumab

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

Disqualifiers: Severe asthma, Cancer, Anaphylaxis, 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: 16 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab. If there is a comparison group: Researchers will compare non-food allergic participants (who do not receive omalizumab) to see if they experience skin barrier abnormalities. All food allergic participants will receive 4 months of Omalizumab treatment as well as two Oral Food Challenges. Participants will all undergo skin barrier assessments.

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 some monoclonal antibody therapies, at least four months before screening. You also need to stop taking antihistamines for a specific period before certain tests.

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}

Eligibility Criteria

This trial is for individuals with confirmed food allergies, as shown by a positive oral food challenge. Participants will receive Omalizumab injections and undergo skin assessments to see if the treatment improves skin barrier issues related to their allergy.

Inclusion Criteria

Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent

I am between 1 and 55 years old.

Participant must meet clinical FA criteria: Food sensitization to specified allergens within 1 year of screening AND experience dose-limiting, IgE mediated symptoms at or before 444mg of food protein cumulatively during screening OFC to specified allergens

Exclusion Criteria

History of severe anaphylaxis to a study food used for qualifying OFC in this study

Inability or unwillingness to give written informed consent and/or assent or comply with the study protocol

I haven't had monoclonal antibody or immunotherapy in the last 4 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 4 months of Omalizumab treatment and undergo regular skin barrier assessments

16 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including end of study Oral Food Challenge and analysis of skin barrier function

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Omalizumab

Trial Overview The study tests whether Omalizumab can reverse skin abnormalities in those with food allergies. Allergic participants get four months of treatment and two oral challenges, while non-allergic controls are observed for comparison.

Participant Groups

Group I: Participants without Food Allergy Active Control 1 Intervention

This group will undergo skin barrier assessment.

Group II: Participants with Food Allergy Active Control 1 Intervention

This group will receive 4 months of Omalizumab treatment, and undergo regular skin barrier assessments.

Who Is Running the Clinical Trial?

National Jewish Health

Lead Sponsor

Trials

145

Recruited

318,000+

Roche-Genentech

Industry Sponsor

Trials

27

Recruited

3,800+

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]