Oral Immunotherapy for Wheat Allergy

Food allergy affects 6-8 percent of children in the United States. Wheat is one of the eight
most common foods inducing allergic reactions in the US. Current treatment for food allergy
is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine
if an accidental reaction occurs. However, accidental exposure to allergens in processed
foods may be difficult to avoid. Currently, several therapeutic strategies are being
investigated to prevent and treat food allergies. Since immunotherapy injections for food
allergy are associated with a high rate of allergic reactions, alternate approaches to
treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried
in some studies in the treatment of food allergies. The intent of the study is to examine the
clinical effects and safety of wheat OIT. This study will last 2 years. All eligible subjects
will receive a wheat oral food challenge (OFC). Those who react to 1923mg or less of vital
wheat gluten will be randomized to Wheat OIT or a placebo. All eligible and enrolled subjects
will have a 1-year and 2-year OFC. Placebo subjects will crossover to Wheat OIT at the 1-year
time point. At selected visits, blood and urine collection, physical examination, prick skin
tests, and atopic dermatitis and asthma evaluations will occur.

Inclusion Criteria:

- Age 4-30 years either sex, any race, any ethnicity

- Positive Prick Skin Test to wheat greater than 3mm compared to control and/or a wheat
specific IgE >= 0.35 kUA/L

- Positive baseline challenge to wheat (<= 1923 mg of vital wheat gluten)

- Written informed consent from subject and/or parent/guardian

- Written assent from all subjects as appropriate

- All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

- History of anaphylaxis to wheat resulting in hypotension, neurological compromise or
mechanical ventilation

- Known allergy to corn

- Known celiac disease

- Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy
(e.g., heart disease, diabetes)

- Active eosinophilic gastrointestinal disease in the past two years

- Participation in any interventional study for the treatment of food allergy in the
past 6 months

- Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance
dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.

- Severe asthma, uncontrolled mild or moderate asthma. More information on this
criterion can be found in the protocol.

- A burst of oral, IM or IV steroids of more than 2 days for an indication other than
asthma in the past 1 month

- Inability to discontinue antihistamines for initial day escalation, skin testing or
OFC

- Use of omalizumab or other non-traditional forms of allergen immunotherapy or
immunomodulator therapy (not including corticosteroids) or biologic therapy within the
past year

- Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors,
angiotensin-receptor blockers (ARB) or calcium channel blockers

- Use of investigational drug within 90 days or plan to use investigational drug during
the study period

- Pregnancy or lactation