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 accepting patients for this trial.

Lead Sponsor:

Boston Children’s Hospital

Collaborator: Ann & Robert H Lurie Children's Hospital of Chicago

Stanford Investigator(s):


  • Drug: Omalizumab
  • Drug: placebo


Phase 1/Phase 2


Inclusion Criteria:

   - 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.

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


Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sue Neale-May, RN