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.
Phase:
Phase 2
Details
Lead Sponsor:
Kari Christine Nadeau
Collaborators:
Ann & Robert H Lurie Children's Hospital of Chicago Children's Hospital Los Angeles Children's Hospital Medical Center, Cincinnati Children's Hospital of Philadelphia Icahn School of Medicine at Mount Sinai University of Washington