Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial

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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

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sue Neale-May, RN
650-723-5227