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Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
Not Recruiting
Trial ID: NCT01781637
Purpose
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.
Official Title
Phase 2 Study of Omalizumab in Oral Peanut Desensitization
Eligibility
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(s):
drug: Omalizumab
drug: placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sue Neale-May, RN
650-723-5227