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.
Conditions
Peanut Allergy, Food Allergy
Recruitment Status
Completed
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.
Eligibility Criteria
Inclusion Criteria:
Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old.
Sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater)
ImmunoCAP IgE level to peanut > 10 kU/L.
Sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (DBPCFC) at maximum of cumulative 175 mg of peanut protein dose.
Exclusion Criteria:
Subjects with a total IgE at screening of < 50 kU/L > 2,000 kU/L.
Positive reaction to the placebo on DBPCFC.
Previous reaction to omalizumab.
Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.
Intervention
Intervention Type
Intervention Name
Drug
Omalizumab
Drug
placebo
Phase
Phase 1, Phase 2
Gender
All
Min Age
7 Years
Max Age
25 Years
Download Date
February 21, 2023
Principal Investigator
Lynda Schneider
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: