Multi OIT to Test Immune Markers After Minimum Maintenance Dose
Condition: Food Allergy
MeSH terms: Food Hypersensitivity
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): Omalizumab; Food Flour Allergens
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Xolair; Food flours
Intervention MeSH terms: Omalizumab
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)
Primary purpose: Treatment
Keywords: Oral Immunotherapy; Omalizumab; OIT; Xolair