Multi OIT to Test Immune Markers After Minimum Maintenance Dose
Condition: Food Allergy
MeSH terms: Food Hypersensitivity
Intervention: Omalizumab; Food Flour Allergens
Intervention description: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.; 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. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.
Intervention MeSH terms: Omalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a phase 2 multi site study that will be conducted at two centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (peanut, egg, milk, wheat, soy, cashew, walnut, almond, hazelnut, sesame seed, cod, salmon and 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.
Masking: Double (Participant, Investigator)
Masking description: Blinded labeling (Individual dosing cups will mention a choice of two doses the participant could be assigned to). Oat flour is used as the filler to create equal volumes for all doses
Enrollment: 60.0
Sex: All
Minimum age: 2 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Oral Immunotherapy; Omalizumab; OIT; Xolair

Summary:

      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.
    

Eligibility criteria:

        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.