Omalizumab for Food Allergy
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: AAADRS Clinical Research Center
Must not be taking: Inhaled steroids, Biologics
Disqualifiers: Asthma, Nasal polyps, Cystic fibrosis, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
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.
12345Is 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.
23678How 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.
12589Eligibility 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.
+9 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Open Label Injection of OmalizumabExperimental Treatment1 Intervention
Omalizumab dose and frequency based on baseline patient weight and total IgE
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
AAADRS Clinical Research CenterCoral Gables, FL
Loading ...
Who Is Running the Clinical Trial?
AAADRS Clinical Research CenterLead Sponsor
References
Use of omalizumab in the treatment of food allergy and anaphylaxis. [2021]Omalizumab is a humanized monoclonal anti-IgE antibody that is currently FDA-approved for allergic asthma. Given its mechanism of action, recent reports have suggested its possible clinical use for food allergy and some forms of anaphylaxis. Omalizumab exerts its action by binding to circulating IgE, reducing IgE receptor expression, and decreasing mediator release from mast cells and basophils. Clinical trials using omalizumab in patients with food allergy resulted in achieving tolerance to higher amounts of the allergen in some patients. When used as an adjunct therapy during immunotherapy trials in patients with food allergy and anaphylaxis, omalizumab allowed more rapid and higher doses of immunotherapy to be given. Omalizumab has also been reported to be effective in a few patients with idiopathic anaphylaxis and mast cell disorders. Large multi-center trials are needed to confirm the above findings, and to identify subsets of patients that would benefit the most from omalizumab.
Effects of omalizumab in patients with food allergy. [2016]Omalizumab is a novel therapy approved for treating patients with moderate to severe persistent allergic asthma with a serum IgE ranging from 30 to 700 IU/mL. We examined the efficacy of omalizumab as a treatment for IgE-mediated food allergy. An Institutional Review Board-approved prospective pilot study was performed to assess the efficacy of omalizumab in 22 patients with persistent asthma and concomitant IgE-mediated food allergy. All patients showed skin test positivity to foods and experienced allergic food reactions based on history. Patients were interviewed on unintentional and/or unauthorized exposures to sensitized foods. Thirteen female and nine male patients (range, 4-66 years old; mean, 38 years) were evaluated in a private practice setting. Mean IgE level was 1120.74 IU/mL. Sensitized allergens included fish, shellfish, peanuts, tree nuts, egg, soybean, and wheat. All 22 (100%) patients maintained significant improvement as shown by a decrease/lack of clinical symptoms on reexposure to sensitized foods. Clinical improvement by the sixth dosage of omalizumab (150-300 mg q. 2-4 weeks) was noted by history and physical examination. Eight patients noted a decrease in their food-induced atopic dermatitis, 13 patients noted a decrease in their food-induced asthma symptoms, 3 patients noted a decrease in their food-induced urticaria, 6 patients noted a decrease in their food-induced rhinosinusitis symptoms, and 9 patients showed efficacy for angioedema and/or anaphylaxis. While treating asthma patients with omalizumab, patients subjectively observed a reduction in their concomitant IgE-mediated food allergy symptoms.
Impact of Omalizumab on Food Allergy in Patients Treated for Asthma: A Real-Life Study. [2020]The effects of omalizumab on food allergy thresholds have been little studied.
Individually dosed omalizumab: an effective treatment for severe peanut allergy. [2018]Treatment with omalizumab has shown a positive effect on food allergies, but no dosages are established. Basophil allergen threshold sensitivity (CD-sens) can be used to objectively measure omalizumab treatment efficacy and correlates with the outcome of double-blind placebo-controlled food challenge to peanut.
Omalizumab as an adjuvant in food allergen immunotherapy. [2021]To review the most relevant studies in the rapidly advancing field of omalizumab as an adjunct to food allergen oral immunotherapy (OIT).
Successful treatment of a patient with adult food allergy and severe asthma using omalizumab. [2021]Food allergy is a typical immediate-onset allergic disease in which symptoms are provoked by exposure to the sensitized antigens. Although previous reports have shown that omalizumab has helped children with egg or milk allergy achieve oral immunotherapy safely, there is still no established method for induction of remission in adult food allergy. A 51-year-old woman with oral steroid-dependent severe asthma was treated with omalizumab for 6 years. She had shellfish and wheat food allergy and oral allergy syndrome induced by kiwi and other foods associated with latex-fruit syndrome. Since omalizumab treatment, her food allergy symptoms had disappeared. After 7 years of this treatment, disseminated erythema suddenly appeared; omalizumab was discontinued because of suspected drug-induced eruption. After omalizumab interruption, she felt an itching sensation in her throat with worsened asthma control immediately after wheat ingestion. Readministration of omalizumab improved these symptoms. Thus, we raised the possibility that omalizumab not only improved asthma control but also induced pharmacological remission of the patient's food allergy. Omalizumab may be considered as a treatment option for adult patients with food allergies and severe asthma.
Delayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma. [2022]Risk of anaphylaxis is included in the prescribing information for omalizumab, but the nature of these reactions merits further elaboration.
Omalizumab in children with severe allergic disease: a case series. [2020]Currently, severe allergic asthma and food allergy in children represent an important public health problem with medical, psychosocial and economic impacts. Omalizumab is a humanized monoclonal anti-IgE antibody, approved for refractory allergic asthma and chronic urticaria. It has been widely used in clinical practice as add-on therapy in patients with severe uncontrolled allergic asthma. In recent years there has seen the emergence of an allergic epidemic with increasing food allergy, which represents the main cause of anaphylaxis in children. The standard of care for food allergy is strictly dietary allergen avoidance and emergency treatment, but recent clinical trials have suggested that omalizumab may have a role to play as an adjuvant to oral immunotherapy (OIT). We present a case series of patients treated at our institution with omalizumab for severe allergic asthma and food allergy.
Omalizumab in IgE-Mediated Food Allergy: A Systematic Review and Meta-Analysis. [2023]A growing number of studies have shown encouraging results with omalizumab (OMA) as monotherapy and as an adjunct to oral immunotherapy (OMA+OIT) in patients with single/multiple food allergies.