Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the addition of anti-IgE treatment will make peanut oral immunotherapy safer, more tolerable, and more effective in treating peanut allergy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Genentech, Inc.
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• Age 12 years and above of either sex, any race, any ethnicity at the time of the initial visit

• The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal > 3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 5 kUA/L

• A history of significant clinical symptoms (urticaria, angioedema, rhinorrhea, nasal congestion, pruritis, sneezing, abdominal pain, emesis, diarrhea, wheezing, shortness of breath, lip/tongue swelling, throat itching, throat swelling, impending sense of doom) occurring within 60 minutes after ingesting peanuts

• Provide signed informed consent

• Women who are sexually active, must agree to use appropriate contraceptive measures for the duration of the study and for 9 months afterwards

Exclusion Criteria:

• History of severe anaphylaxis to peanut or omalizumab as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or oxygen saturation < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)

• Currently participating in a study using an investigational new drug

• Participation in any interventional study for the treatment of food allergy in the past 12 months

• Subjects with a known oat or wheat (because of potential cross contamination with oat) food allergy will be excluded

• Poor control or persistent activation of atopic dermatitis

• Moderate to severe persistent asthma

• Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines

• Inability to discontinue antihistamines for skin testing and oral food challenges (OFCs)

• History of other serious underlying disease (i.e., heart disease, diabetes, etc.)

• Women who are pregnant or nursing