Multi Immunotherapy to Test Tolerance and Xolair
Condition: Food Allergy
MeSH terms: Food Hypersensitivity
Intervention: Omalizumab; Food Flour Buildup
Intervention description: Omalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.; Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized.
Intervention MeSH terms: Omalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 4 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This is a phase 2 randomized, double-blind, placebo controlled study which will be conducted
      at multiple centers in the U.S. All subjects will receive oral immunotherapy for their
      specific food allergies (limited to 5 of those food allergens in Investigational New Drug
      (IND) 14831). All subjects will receive Omalizumab for 16 weeks. The subject's allergens will
      be introduced in a rush desensitization day at week 8. Subjects will return to clinic to
      escalate the dose of their allergens until 2,000mg protein of each allergen is reached
      Subjects will return to clinic for a DBPCFC to each allergen at week 30. If subjects are
      nonreactive to 2 or more allergens during their DBPCFC at week 30 they will be randomized to
      one of three double blinded arms: Arm A- continue with current dose (2000 mg each food
      allergen protein), Arm B-300 mg of each food allergen protein, Arm C-placebo (avoiding food
      allergen protein), their current dose. All subjects will return to clinic for a DBPCFC to
      each allergen at week 36. The final challenge of week 36 will be the final end of study
      visit.

      Safety is a paramount concern in the study design and will be monitored carefully throughout
      the study. Study subjects and their parents/guardians will receive extensive education on
      food allergy reactions and medication use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant and/or parent guardian must be able to understand and provide informed
             consent and/or assent as applicable.

          -  Age 4 to 55 years with moderate to severe allergy to 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

          -  Positive skin prick test result greater than or equal to 6 mm wheal diameter to each
             allergen OR

          -  ImmunoCAP Immunoglobulin E (IgE) level >4 kilo Unit/Liter for each allergen and

          -  A clinical reaction during a DBPCFC to small doses of food defined as < dose of 500 mg
             food protein

          -  No clinical reaction observed during the placebo (oat) challenge and

          -  If female, must have a negative urine pregnancy test on the same day (using a Clinical
             Laboratory Improvement Amendment (CLIA) approved urine test)

          -  If female, of child-bearing potential, must agree to be compliant with a
             medically-approved method of contraception (please see Pregnancy section under Patient
             Disposition in this protocol)

          -  Plan to remain in the study area of the research center during the trial

          -  Be trained on the proper use of the Epinephrine autoinjector

          -  Avoid open or blinded food challenges to other allergens outside this study

        Exclusion Criteria:

          -  Inability or unwillingness of a participant/parent/guardian to give written informed
             consent or comply with study protocol

          -  History of cardiovascular disease

          -  History of other chronic disease (other than asthma, atopic dermatitis, or rhinitis)
             requiring therapy (e.g., heart disease, diabetes) that, in the opinion of the
             Principal Investigator, would represent a risk to the participant's health or safety
             in this study or the participant's ability to comply with the study protocol

          -  A total IgE at screening of >2,000 kU/L

          -  Previous adverse reaction to Xolair

          -  A history of severe anaphylaxis (defined as requiring intubation or admission to an
             ICU) to food allergens that will be used in this study

          -  Unstable angina, significant arrhythmia, uncontrolled hypertension, current smokers,
             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 participant.

          -  Current use of oral, intramuscular, or intravenous corticosteroids, tricyclic
             antidepressants, or betablockers (oral or topical)

          -  Routine use of medication that could induce adverse gastrointestinal reactions during
             the study

          -  Refusing to sign the Epinephrine autoinjector Training Form

          -  Pregnant or breast feeding women

          -  A history of oat allergy (since oat is the placebo agent in the DBPCFC), or an
             objective reaction to the screening DBPCFC to oat

          -  Unwilling to avoid all food allergen-containing items except those given as part of
             the Oral Immunotherapy as well as any other food allergens you are allergic to that
             are not included in the 10 foods listed in the study

          -  Concurrent/prior use of immunomodulatory therapy (within 1 month) ie, omalizumab,
             nontraditional forms of allergen immunotherapy (e.g., oral or sublingual)

          -  Severe asthma (2007 National Heart Lung and Blood Institute (NHLBI) Criteria Steps 5
             or 6) at time of enrollment

          -  Mild or moderate asthma (2007 NHLBI Criteria Steps 1-4) at time of enrollment with any
             of the following criteria met:

          -  Forced Expiratory Volume at one second (FEV1) < 80% of predicted, or FEV1/Forced Vital
             Capacity (FVC) < 75%, with or without controller medications (only for age 6 or
             greater and able to do spirometry) or

          -  Inhaled Corticosteroid (ICS) dosing of > 220 mcg daily fluticasone (or equivalent
             inhaled corticosteroids based on NHLBI dosing chart) or

          -  1 hospitalization in the past year for asthma or ER visit for asthma within the past
             six months

          -  Use of steroid medications (Intravenous (IV), Intramuscular (IM) or oral) in the
             following manners

          -  history of daily oral steroid dosing for >1 month during the past year or

          -  steroid burst course ( 5 or more days) of 1 mg/kg prednisone) course in the past 3
             months or

          -  >2 steroid burst courses in the past year

          -  Use of complementary and alternative medicine (CAM) treatment modalities (e.g., herbal
             remedies) for atopic and/or non-atopic disease within 90 days preceding rush
             desensitization at week 8or at any time .

          -  Inability to discontinue antihistamines for the initial day of escalation, skin
             testing or Oral Food Challenges (OFCs)

          -  Use of investigational drugs within 24 weeks of participation

          -  Past or current medical problems or findings from physical assessment or laboratory
             testing that are not listed above, which, in the opinion of the investigator, may pose
             additional risks from participation in the study, may interfere with the participant's
             ability to comply with study requirements or that may impact the quality or
             interpretation of the data obtained from the study.