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.
Intervention(s):
- drug: Omalizumab
- drug: placebo
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.
Ages Eligible for Study
7 Years - 25 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sue Neale-May, RN
650-723-5227
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.
