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

The goal of this proposal is to produce a new treatment that would benefit subjects who have
peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing
the peanut-specific immune response in subjects who have peanut allergy (tolerance). This
project is designed to study if peanut oral immunotherapy (OIT) will desensitize subjects
with peanut hypersensitivity by regulating their oral and systemic immune reactivity and
cause long-term tolerance. This study will augment other ongoing studies by looking at
whether anti-IgE therapy can reduce side effects and allow for an accelerated build up phase.
Peanut allergic patients greater than 12 years old will undergo omalizumab (anti-IgE)
treatment for 4 months prior to peanut OIT, and they will continue omalizumab until one month
after maintenance therapy. Each subject will have an initial desensitization phase over 2
days to a goal of 950 mg of peanut powder followed by a build up phase over 4 months to goal
maintenance dose of 8000 mg peanut powder. They will be randomized to continue maintenance
for 12 or 24 months. They will then have an oral food challenge (OFC) immediately after
stopping peanut OIT to test for desensitization. Four weeks later, off OIT, another food
challenge will be done to assess tolerance. Outcome variables of interest include results of
the OFCs, pre and post skin tests, CAP-FEIA values and basophil studies. These results will
be compared between the starting point and the patient at the end of the study using
appropriate statistical analysis.

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