NCT01846208.

Trial name or title	Oral desensitization to egg with subsequent induction of sustained unresponsiveness for egg‐allergic children using baked egg or egg oral immunotherapy
Methods	Open‐label, parallel group, RCT Quote: "The purpose of this study is to compare baked foods with egg versus egg oral immunotherapy. The intent of the study is to investigate if participants will be able to consume egg after taking baked foods with egg or egg oral immunotherapy for a period of time and then stopping for a certain period. This is referred to as tolerance or sustained unresponsiveness. This study will evaluate the effectiveness of the egg oral immunotherapy versus baked egg by having each participant ingest egg white solid or baked foods with egg. This will be done over 2 years. This study will last 2 years. All eligible subjects will receive a baked egg oral food challenge who pass the baked egg oral food challenge will then have a 2 g egg oral food challenge. Those who react to the egg oral food challenge will be randomized to baked egg or egg oral immunotherapy. Individuals who do not pass the initial baked egg oral food challenge will be assigned to egg oral immunotherapy. Those who pass the egg oral food challenge will not be eligible for the study and will be followed per site standard of care. All eligible and enrolled participants will have a 1‐year and a 2‐year oral food challenge. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur"
Participants	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 oral food challenge with dose‐limiting symptoms OR Reacting on a 2 g egg oral food challenge with dose‐limiting symptoms to a cumulative dose of 2 g or less after passing the initial baked egg oral food challenge Written informed consent from subject or parent or guardian Written assent from all participants 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 oral food challenge 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
Interventions	Egg oral immunotherapy in the form of egg white solid with up to four oral food challenges as directed by protocol. Baked egg in the form of home‐baked goods and 'safe' commercial products with up to four oral food challenges. 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
Outcomes	Primary outcome: the development of sustained unresponsiveness to egg consumption at 2 years Secondary outcome: incidence of all serious adverse events during the study; changes in egg‐specific mechanistic measures and prick skin test results
Starting date	July 2013
Contact information	Icahn School of Medicine at Mount Sinai, Jaffe Food Allergy Institute, USA
Notes	www.cofargroup.org