Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients
Condition: Food Allergy
MeSH terms: Food Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a pilot randomized, double-blind, placebo controlled study which will be conducted at
      a single center. All participants will receive oral immunotherapy for their specific food
      allergies (limited to 5 of those food allergens in IND 14831). In a 3:1 ratio, 36*
      participants will receive Xolair for 16 weeks while 12* will receive corresponding placebo
      instead of Xolair. 12 controls will be enrolled who will receive no OIT and no Xolair. These
      12 controls are not part of the randomization. The total number of participants randomized to
      the two arms is 48*.
    

Detailed description: 
      We will enroll multi food allergic participants (4-55 years of age) with proven "multi food
      allergies". We anticipate enrolling 60 participants with allergies to, at least two foods.
      Participants must have food specific IgE>4kU/L for each allergen or a skin test reactivity to
      each food allergen ≥ 6 mm wheal diameter. We have chosen criteria associated with a very low
      likelihood of natural loss of food allergy for the duration of this protocol. These values of
      specific IgE and SPT were chosen based on the opinions of 4 experts. Participants also must
      have a total IgE <1500kU/L, a clinical reaction during a double blind placebo controlled food
      challenge (DBPCFC) with food proteins/powders to establish sensitivity to given food
      proteins/powders (milk, egg, peanut, almond, wheat, cashew, sesame seed, soy, walnut,
      hazelnut) and no clinical reaction during placebo (oat) as per CMC section of IND.

      Participants will undergo a rush desensitization day at week 8 to a maximum dose of 1,250 mg
      total protein. Participants will be ingesting either 2 to 5 food allergens, depending on
      their allergy screening. They will consume home doses for two weeks based on the these
      results and document reactions. Upon returning to the CFRU (Clinical Food Research Unit) two
      weeks later, a dose escalation will be attempted. This cycle will continue until the
      participant reaches a maximum dose of 2,000 mg protein daily of each food allergen (two to
      five food allergens to be ingested by the participant). No more than 5 allergens will be
      given.
    

Intervention name(s): Xolair; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria; Placebo
Other intervention name(s): omalizumab
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In a 3:1 ratio, 36* participants will receive Xolair for 16 weeks while 12* will receive corresponding placebo instead of Xolair. 12 controls will be enrolled who will receive no OIT and no Xolair. These 12 controls are not part of the randomization. The total number of participants randomized to the two arms is 48*.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment