Omalizumab for Food Allergy

(OWED-T Trial)

Recruiting at 2 trial locations

Overseen By Jannat Gill

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

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

Disqualifiers: Severe asthma, Severe 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: Unknown

Duration: 16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of higher doses of Omalizumab, a medication for treating food allergies. Researchers are dividing participants into two groups to test different dosing levels. This trial may suit individuals who have had allergic reactions to foods like peanuts, eggs, or milk and have experienced issues such as skin reactions or breathing problems after consuming these foods. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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, and β-blockers. Additionally, you must be able to stop taking antihistamines for specific periods needed for certain tests.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Omalizumab, a treatment tested for food allergies, has safety data from earlier studies. The most common side effects are mild, such as injection site reactions and fever. Importantly, these studies did not observe severe allergic reactions like anaphylaxis.

The FDA has already approved Omalizumab to reduce allergic reactions, indicating its safety in other conditions. When used for food allergies, it has helped many people avoid moderate to severe allergic symptoms. Although this trial tests higher doses, the existing safety information offers some reassurance about its use. ^{1 2 3 4 5}

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

Researchers are excited about omalizumab for treating food allergies because it offers a new approach by targeting the underlying allergic response. Unlike standard treatments that mainly involve avoiding allergens or using antihistamines to manage symptoms, omalizumab works by blocking immunoglobulin E (IgE), a key player in allergic reactions. This mechanism can potentially reduce the severity of allergic responses and increase the threshold for reactions. Additionally, the trial explores two different dosing regimens, 15mg/kg and 5mg/kg, which could provide flexibility in treatment options and personalization based on patient needs. This innovative approach might offer more comprehensive protection and improved quality of life for individuals with food allergies.

What evidence suggests that increased dosing of Omalizumab could be effective for food allergies?

Research has shown that Omalizumab can increase tolerance to food allergens like peanuts. In one study, 68% of patients who received Omalizumab were protected from moderate to severe allergic reactions. Another study found that 36% of participants could consume 2 grams or more of peanut protein without issues after treatment. Additionally, 83.9% of patients responded positively to Omalizumab, highlighting its potential in managing food allergies. This trial will compare two dosages of Omalizumab, 15mg/kg and 5mg/kg, to evaluate its effectiveness in reducing allergic reactions in individuals with food allergies. ^{3 5 6 7 8}

Who Is on the Research Team?

Wayne Shreffler, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with allergies to specific foods (peanut, cashew, walnut, egg, or milk) confirmed by tests and a history of reactions. Participants must have reacted to an oral food challenge at low doses. Exclusions include severe allergic reactions in the past, pregnancy, certain chronic diseases or treatments like cancer therapy within six months.

Inclusion Criteria

Positive food specific IgE (≥2.0 kUA/L) to at least two of the relevant foods

A positive prick skin test (PST) with a wheal ≥ 6 mm to at least two of the relevant foods (peanut, cashew, walnut, egg, or milk)

A positive history of clinical reaction to at least one of the qualifying foods other than the challenge-qualifying food

Exclusion Criteria

Clinically significant laboratory abnormalities at screening

Sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab

History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise, PICU admission for continuous epinephrine for hypotension or severe respiratory compromise requiring intubation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Omalizumab at either 15mg/kg or 5mg/kg per month, divided every two weeks for 16 weeks

16 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 two different dosages of omalizumab injections (5mg/kg and 15mg/kg) to determine their safety and effectiveness in treating food allergies. The goal is to see if higher doses can better manage symptoms.

How Is the Trial Designed?

Group I: Patients Receiving 15mg/kg of omalizumab Active Control 1 Intervention

Participants randomized to this arm will receive a does of 15mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks.

Group II: Patients Receiving 5mg/kg of omalizumab Active Control 1 Intervention

Participants randomized to this arm will receive a does of 5mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

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]

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]

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]

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]

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 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, 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.

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 ...

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.

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%) ...

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 ...