Conditions: Peanut Allergy Food Allergy
Keywords: Xolair omalizumab peanut oral desensitization
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

Brief summary:
The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.

Detailed description:
36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital.

Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut.

Arms:
arm 1: Patients will receive omalizumab. arm 2: Patients will receive placebo.

Interventions: intervention 1: Omalizumab intervention 2: placebo
Intervention descriptions: intervention 1: subcutaneous injection intervention 2: subcutaneous injection

Protocol document: