Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy

• Status: Completed
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hugh A Sampson, MD
• Collaborators: Consortium of Food Allergy Research; National Institute of Allergy and Infectious Diseases (NIAID)

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