Oral Immunotherapy for Childhood Egg Allergy

In the United States, as many as 6% to 8% of children are affected by food allergy. In young
children, allergic reactions to egg can range from mild rash to systemic anaphylaxis. The
usual standard of care for allergy is complete avoidance of this food allergen and treatment
of accidental systemic reactions by access to self-injected epinephrine. 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
standard injection (under the skin) immunotherapy for food allergy is associated with a high
rate of allergic reactions, a few studies have recently tried oral immunotherapy (OIT) in
food allergy. The purpose of this study is to determine the safety and efficacy of the
administration of OIT. The intent is to develop desensitization and eventually tolerance to
egg allergen. This study will evaluate tolerance to egg white solid that may be gained by
gradually increasing the amounts of egg white solid given to a child over a long period of
time.

This study will last up to 48 months. The participants will be randomly assigned to receive
oral immunotherapy treatment with egg white solid or placebo. This study will include dose
escalation and maintenance followed by oral food challenge (OFC).

For participants receiving egg OIT, visit 1 consists of multiple small incremental doses of
egg white solid. This is followed by 32-40 weeks of gradual dose escalation to a stable
maintenance dose of egg white solid for at least 8 weeks. At approximately Week 44,
participants are given an OFC using 5 grams of egg white solid to identify desensitized
individuals. Participants and study staff are unblinded following this initial OFC.
Maintenance egg OIT therapy is continued for an additional 1-3 years. Oral Food Challenges
with 10 grams of egg white solid will be performed for participants on maintenance egg OIT at
subsequent time points (approximately Week 96 and annually thereafter) to test for
desensitization. If passed, a repeat OFC after being off therapy for 4-6 weeks will be
performed to test for tolerance. An OFC to test for tolerance will use 10 grams of egg white
solid and be followed by an open feeding of egg.

Participants receiving placebo during dose escalation and maintenance are given an OFC using
5 grams of egg white solid to test for desensitization at approximately 44 weeks. They are
unblinded at that time, continue on an egg-restricted diet, and are followed until up to 2
years. These participants will only receive an OFC at a subsequent time point if their egg
Immunoglobulin E (IgE) declines to be less than 2 kilounits of antibody per liter; this OFC
will use 10 grams of egg white solid and be followed by an open feeding of egg.

At selected visits, blood and urine collection, physical examination, prick skin tests, and
atopic dermatitis and asthma evaluations will occur.

Inclusion Criteria:

- Convincing clinical history of egg allergy

- Age 6 to 18 years, with a serum IgE [UniCAP] to egg > 5 kUA/L OR

- Age 5 to 6 years, with a serum IgE [UniCAP] to egg ≥ 12kUA/L

- Parent/guardian willing to provide informed consent

- Willing to use acceptable forms of contraception

Exclusion Criteria:

- History of severe anaphylaxis to egg. More information on this criterion can be found
in the protocol.

- Known allergy to corn

- Chronic disease requiring therapy (e.g., heart disease, diabetes). Participants who
have asthma, atopic dermatitis, or rhinitis are not excluded.

- Participation in any interventional study for the treatment of food allergy in the 6
months prior to study entry

- Participant is on "build-up phase" of immunotherapy and has not reached maintenance
dosing. Participants tolerating maintenance allergen immunotherapy are not excluded.

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

- Inability to discontinue antihistamines for the initial day of escalation, skin
testing, and OFC

- Omalizumab or other nontraditional forms of oral or sublingual allergen immunotherapy,
immunomodulator therapy, or biologic therapy in the 12 months prior to study entry.
Participants who have taken corticosteroids are not excluded.

- Investigational drugs 90 days prior to study entry or planned use of an
investigational drug during the study period

- Pregnancy or breastfeeding