Peanut Oral Immunotherapy in Children

An initial oral food challenge (OFC) to 1 g of peanut flour (500 mg peanut protein) will be
conducted. Participants must have a clinical reaction during this OFC to initiate study
dosing. After the initial OFC, the study design includes four phases:

- Initial dose escalation (1 day): Peanut or placebo dosing will be given incrementally
and increase every 20 minutes until a dose of 12 mg peanut flour (6 mg peanut protein)
or placebo flour is given.

- Build-up (30 weeks): Initial observed dose administration of highest tolerated dose,
followed by daily OIT at home with return visit every 2 weeks for dose escalation.

- Maintenance (104 weeks):The participant will continue on daily OIT with return visits
every 13 weeks. At the end of this phase the participant will undergo a blinded OFC to
10 g peanut flour (5 g peanut protein).

- Avoidance (26 weeks): In this final phase participants will be seen every 13 weeks. At
the completion of this phase participants will have a final blinded OFC to 10g peanut
flour (5 g peanut protein).

Inclusion Criteria:

- Clinical history of peanut allergy or avoidance of peanut without ever having eaten
peanut;

- Serum immunoglobulin E (IgE) to peanut of ≥5 kUA/L determined by UniCAP™, an in-vitro
test system for diagnosis and monitoring of allergy and inflammation;

- Wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control;

- A clinical reaction at or below ingestion of 1 g peanut flour (500 mg peanut protein)
during screening OFC;

- Written informed consent from parent/guardian.

Exclusion Criteria:

- History of severe anaphylaxis with hypotension to peanut;

- Documented clinical history of allergy to oat;

- Suspected allergy to oat and a wheal ≥7mm on skin prick test to oat extract compared
to a negative control;

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

- Active eosinophilic gastrointestinal disease in the past 2 years;

- Participation in any interventional study for the treatment of food allergy in the 6
months prior to visit -1;

- Inhalant allergen immunotherapy that has not yet reached maintenance dosing;

- Severe asthma, as indicated by repeated hospitalizations or hospital emergency
department visits;

- Moderate asthma defined according to National Asthma Education and Prevention Program
Expert;

- Panel that requires more than fluticasone 440 mcg or its equivalent daily for adequate
control;

- Inability to discontinue antihistamines for skin testing, OFC and the initial dose
escalation;

- Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral
or sublingual) in the 12 months prior to visit -1;

- Any systemic therapy which in the judgment of the investigator could be
immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, systemic
corticosteroid therapy of up to a total of three weeks is allowed;

- Use of any investigational drug in 90 days prior to visit -1;

- Plan to use any investigational drug during the study period;

- The presence of any medical condition that the investigator deems incompatible with
participation in the trial.