Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Intervention: Egg Oral Immunotherapy; Baked Egg
Intervention description: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.; Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 3 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Egg Allergy; Egg Oral Immunotherapy; Food Allergy

Summary:

      The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing
      sustained unresponsiveness to egg exposure in children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 3 through 16 years with a serum IgE to egg of >= 5 kUA/L within the past 12
             months]

          -  Reacting to the initial baked egg OFC with dose limiting symptoms OR

          -  Reacting on a 2 gm egg OFC with dose limiting symptoms to a cumulative dose of 2 gm or
             less after passing the initial baked egg OFC

          -  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 egg resulting in hypotension, neurological compromise or
             mechanical ventilation

          -  Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy
             (e.g., heart disease, diabetes)

          -  Active eosinophilic gastrointestinal disease in the past 2 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, or uncontrolled mild or moderate asthma. More information on these
             exclusion criteria can be found in the protocol.

          -  Inability to discontinue antihistamines for initial day escalation, skin testing or
             OFC

          -  Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral
             or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic
             therapy (e.g. infliximab, rituximab, etc.) 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