Overview

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