Baked Milk Oral Immunotherapy for Cow's Milk Allergy

This study is designed to assess the safety of baked milk oral immunotherapy among patients
who are milk allergic and who do not pass a baked milk challenge.

Inclusion Criteria:

- Patients who meet all of the following criteria are eligible for enrollment as study
participants, including participants who:

- Are age 3-18 years, either sex, any ethnicity or race

- Provide signed informed consent by parent or legal guardian and informed assent
if applicable

- Have a history of symptomatic reactivity to cow's milk (i.e. eczema, urticarial,
upper or lower respiratory symptoms, gastrointestinal disturbances, rash, oral
symptoms)

- Have a skin prick test positive to milk (diameter of wheal 3 mm ≥ negative
control) and serum milk-specific immunoglobulin E (IgE) level >5 kiloUnits (kU)/L
within the past 6-12 months

- Have a positive reaction to a cumulative dose of ≤444 mg of baked milk powder in
the initial qualifying double blind placebo-controlled food challenge.

- Use an effective method of contraception by females of childbearing potential to
prevent pregnancy and agree to continue to practice an acceptable method of
contraception for the duration of their participation in the study.

- Have self-injectable epinephrine available at all times

Exclusion Criteria:

- Patients who meet any of these criteria are not eligible for enrollment as study
participants, including participants who:

- Have a history of severe anaphylaxis resulting in hypotension, neurological
compromise, or mechanical ventilation

- Have a history of intubation related to asthma

- Tolerate more than 444 mg of baked milk powder at the initial qualifying double
blind placebo controlled food challenge.

- Allergy to placebo ingredients or reacts to any dose of placebo during the
qualifying oral food challenge.

- Poor control of atopic dermatitis

- Are unable to tolerate at least 3 mg of baked milk protein on dose escalation day

- Are pregnant or lactating

- Have severe asthma defined by 2007 National Heart Lung and Blood Institute
(NHLBI) Criteria Steps 5 or 6

- Have severe or poorly controlled asthma defined by with any of the following
criteria:

1. Forced expiratory volume in 1 second (FEV1) <80% of predicted

2. Inhaled corticosteroid dosing dosing of >500 mcg daily of fluticasone (or
equivalent inhaled corticosteroids based on NHLBI dosing chart) or

3. ≥ 1 hospitalization in the past year for asthma or

4. > 1 emergency department visit in the past 6 months for asthma

- Use of steroid medications (oral steroids, such as prednisone or Medrol, steroid
injections, such as Kenalog, or intravenous or oral corticosteroid burst) in the
following manners: History of daily oral steroid dosing within 4 weeks prior to
baseline visit or for > 1 month during the past year or >2 burst oral steroid
courses in the past 6 months.

- Are unable to discontinue antihistamines for 5 days for long acting and 3 days
for short acting prior to skin testing or food challenges

- Are receiving omalizumab, mepolizumab, beta- blocker,
angiotensin-converting-enzyme inhibitor (ACE-I), angiotensin-receptor blockers,
calcium channel blockers, or tricyclic antidepressant therapy

- Have used immunomodulatory therapy (not including corticosteroids) or biologic
therapy within the past year

- Have participated in any interventional study for treatment of a food allergy in
the past 6 months

- Are on 'build up phase' of environmental allergen immunotherapy. Subjects
tolerating maintenance allergen immunotherapy can be enrolled.

- Have a history of eosinophilic esophagitis in the past 3 years

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

- Have used an investigational drug within 90 days or plan to use an
investigational drug during the study period

- Severe reaction at initial double blind placebo controlled food challenge,
defined as:

- Life-threatening anaphylaxis

- Requiring overnight hospitalization