A Study of Sublingual Immunotherapy in Peanut-allergic Children

In spite of increased recognition and understanding of food allergies, food-induced
anaphylaxis remains the single most common cause of anaphylaxis seen in hospital emergency
departments, accounting for about one third of anaphylaxis cases seen. It is estimated that
about 30,000 food-induced anaphylactic events are seen in U.S. emergency departments each
year and that about 200 fatal cases occur in the U.S. each year. Either peanuts or tree nuts
cause more than 80% of these reactions. No treatments are available and avoidance is the only
approved intervention.

The goal of this study is to investigate peanut sublingual immunotherapy (SLIT) as a
treatment for children with peanut allergy. This study is primarily designed to evaluate the
efficacy and safety of peanut SLIT compared to placebo after 12 months. Secondarily, the
study is designed to evaluate the efficacy of extended maintenance dosing of peanut SLIT in
inducing lasting tolerance after discontinuation of the peanut SLIT. Mechanistic studies will
be completed concurrently as exploratory endpoints to understand changes in the allergic
immune response related to peanut SLIT.

Inclusion Criteria:

- Peanut IgE > 7kU/L (> 2kU/L for children aged 2 years and under) AND

- History of significant clinical symptoms within 60 minutes after the ingestion of
peanuts.

Exclusion Criteria:

- History of severe life-threatening anaphylaxis to peanut, OR

- Medical history that would prevent a DBPCFC to peanut, OR

- Subjects with wheat or oat allergy (which are used in the placebo), OR

- Unable to cooperate with challenge procedures, OR

- Unable to be reached by telephone for follow-up