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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether omalizumab can reverse skin problems in people with food allergies. Researchers aim to determine if individuals with food allergies have compromised skin barriers and if omalizumab can repair them. Those allergic to common items like peanuts or tree nuts and who have experienced noticeable reactions during food challenges might be suitable candidates. Participants will undergo skin assessments, with some receiving omalizumab treatment, while others without food allergies will serve as a comparison group. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective omalizumab benefits more patients.

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 is the safety track record for this treatment?

In a previous study, most patients tolerated omalizumab well. About 84% of patients responded positively to the treatment, while only around 10% did not. Another study demonstrated that omalizumab increased the amount of allergen needed to trigger a reaction, benefiting those with food allergies. Omalizumab is already approved for treating other conditions, such as severe allergic asthma, indicating that its safety profile is well understood. While some side effects may occur, they are usually mild. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Omalizumab for food allergies because it offers a new approach by targeting the immune system's IgE antibodies, which play a key role in allergic reactions. Unlike standard treatments that mainly focus on avoiding allergens or providing emergency medication like antihistamines, Omalizumab works by reducing the body’s sensitivity to allergens. This could potentially offer a more proactive and long-term solution, allowing people with food allergies to have fewer reactions and more dietary freedom.

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

Research has shown that omalizumab can help treat food allergies. In one study, 83.9% of patients responded positively, experiencing fewer allergic reactions. Another study found that after 16 weeks of omalizumab, patients could consume more peanuts and other common food allergens without issues. Additionally, 68% of patients were protected from moderate to severe allergic symptoms, compared to only 5% who took a placebo. In this trial, participants with food allergies will receive 4 months of omalizumab treatment and undergo regular skin barrier assessments. This evidence suggests that omalizumab can significantly help people with food allergies manage their symptoms better. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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

I am between 1 and 55 years old.

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

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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, 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]

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. worldallergyorganizationjournal.org worldallergyorganizationjournal.org/article/S1939-4551(25)00023-7/fulltext

Efficacy of omalizumab in food allergic adults Fifty-two (52/62) patients (83.9%) were classified as treatment responders. Six (6/62) patients (9.7%) developed unresponsiveness, 6/62 (9.7%) ...

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 · First- ...

5. 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 ...

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

Omalizumab in food allergy: Risks and benefits - PMC In a study of patients with severe allergic asthma and food allergy treated with omalizumab alone, there was an 8.6-fold increase in the reaction threshold dose ...