Trial Search Results
Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
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.
Stanford is currently not accepting patients for this trial.
Boston Children’s Hospital
Collaborator: Ann & Robert H Lurie Children's Hospital of Chicago
- Drug: Omalizumab
- Drug: placebo
Phase 1/Phase 2
- Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years
- 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.
- 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
Ages Eligible for Study
7 Years - 25 Years
Genders Eligible for Study