Multi OIT to Test Immune Markers After Minimum Maintenance Dose

A Phase 2 Study Multi Oral Immunotherapy in Multi Food Allergic Patients to Test Immune Markers After Minimum Maintenance Dose

Few studies have been conducted to optimize safety of multiple food allergen oral immunotherapy (OIT) in conjunction with Omalizumab as well as to identify the immunological mechanism(s) underlying any long-lasting effects of OIT. To address these issues in the field of food allergy research, we have designed this study to test whether: 1) Omalizumab improves the safety of multiple food allergen OIT in subjects with multi food allergies, 2) Omalizumab treatment with multiple food allergen OIT is associated with the ability to use a lower maintenance dose of each food allergens in the OIT regimen, particularly in younger subjects with food allergies.

This is a phase 2 multisite study that will be conducted at two centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (peanut, milk, egg, soy, wheat, cashew, walnut, almond, hazelnut, cod, salmon, sesame, shrimp). All participants will receive three doses of Omalizumab 4 weeks apart over 8 weeks. The subject's allergens will be introduced after receiving the third omalizumab dose. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B.

Food protein and powder will be obtained and prepared as per Investigational New Drug 14831 and will be in compliance with all applicable regulations.

Omalizumab is approved by the European Medicines Agency (European FDA) and by the US FDA. Omalizumab will be dosed according to Genentech Dosing Omalizumab will be provided by the site.

Inclusion Criteria:

• Aged 2 to 25 years with clinical history of allergy to at least two of the following: milk and/or egg and/or peanut and/or almond and/or wheat and/or cashew and/or sesame seed and/or soy and/or pecan and/or walnut and/or hazelnut and/or shrimp and/or cod and/or salmon and
• Sensitivity to food allergens documented by a positive skin prick test result greater than or equal to 6mm wheal diameter to each allergen or
• ImmunoCAP IgE level >4kU/L for each allergen and
• If female of child bearing potential, a negative urine pregnancy test before being allowed to participate in the study (week 0) and
• A plan to remain in the study area of the research center during the trial and
• Be trained on the proper use of the Epinephrine autoinjector and agree to follow epi training to be allowed to enroll in the study and
• If female of child-bearing potential, willing to be compliant with a medically-approved method of contraception (please see Pregnancy section in this IND document) and
• Agree to eliminate other known food allergens from subject's diet so as not to confound the safety and efficacy data from the study and
• Avoid open or blinded food challenges to food allergens

Exclusion Criteria:

• Previous anaphylactic reaction to Omalizumab
• A history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma
• Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation or administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease)
• An average forced expiratory volume at one second (FEV1) or peak expiratory flow rate (PEF) less than 80% predicted (moderate persistent asthma) with or without controller medication (if able to perform the maneuver) at screening, or a food challenge visit
• Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or are taking a beta-blocker (oral or topical)
• Routinely using medication that could induce adverse gastrointestinal reactions during the study
• Refusing to sign or follow the Epinephrine autoinjector Training Form
• Pregnant or breast feeding women
• Unwilling to avoid other allergens outside this study
• Concurrent/prior use of immunomodulatory therapy (within 6 months)
• A diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis.