Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy

Completed · Phase 2

Conditions studied: Food Allergy

In brief

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

Key facts

Study ID

NCT01846208

Run by

Hugh A Sampson, MD

People needed

92

Starts

2013-07-01

Expected to finish

2018-09-30

Last updated by the study team

2019-07-26

Who can join

Age: 3 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• National Jewish Health — Denver, Colorado, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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