Clinical Trial: Oral Immunotherapy for Childhood Egg Allergy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Oral Desensitization to Egg With Subsequent Induction of Tolerance for Egg-Allergic Children (CoFAR 3)

Brief Summary: The purpose of this study is to determine if oral immunotherapy (OIT) will desensitize a child with an allergy to egg and eventually lead to the development of tolerance to egg.

Detailed Summary:

In the United States, as many as 6% to 8% of children are affected by food allergy. In young children, allergic reactions to egg can range from mild rash to systemic anaphylaxis. The usual standard of care for allergy is complete avoidance of this food allergen and treatment of accidental systemic reactions by access to self-injected epinephrine. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since standard injection (under the skin) immunotherapy for food allergy is associated with a high rate of allergic reactions, a few studies have recently tried oral immunotherapy (OIT) in food allergy. The purpose of this study is to determine the safety and efficacy of the administration of OIT. The intent is to develop desensitization and eventually tolerance to egg allergen. This study will evaluate tolerance to egg white solid that may be gained by gradually increasing the amounts of egg white solid given to a child over a long period of time.

This study will last up to 48 months. The participants will be randomly assigned to receive oral immunotherapy treatment with egg white solid or placebo. This study will include dose escalation and maintenance followed by oral food challenge (OFC).

For participants receiving egg OIT, visit 1 consists of multiple small incremental doses of egg white solid. This is followed by 32-40 weeks of gradual dose escalation to a stable maintenance dose of egg white solid for at least 8 weeks. At approximately Week 44, participants are given an OFC using 5 grams of egg white solid to identify desensitized individuals. Participants and study staff are unblinded following this initial OFC. Maintenance egg OIT therapy is continued for an additional 1-3 years. Oral
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome: Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg [ Time Frame: At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy ]

Original Primary Outcome: Percent of participants who can tolerate 10,000 mg of egg white solid 4 to 6 weeks after discontinuing egg oral immunotherapy (OIT)

Current Secondary Outcome:

• Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid [ Time Frame: Following the blinded desensitization phase at approximately Week 44 ]
  Desensitization assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were counted as successes.
• Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation [ Time Frame: Initial day of dosing ]
  On the initial day of dosing, participants were offered 0.1 mg of egg white solid or placebo followed by an approximate doubling every 30 minutes up to a 50 mg dose providing limiting reactions do not occur.
• Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg [ Time Frame: Following the blinded desensitization phase at approximately Week 44 ]
  For participants whose maximum tolerated dose on the initial escalation day was less than 50 mg, doses were doubled every 2 weeks up to 50 mg. After 50 mg, dosing was increased to 75 mg, and then dosing increased by 25% until the 2000 mg dose was reached. The maximum time allowed for the build-up phase was 40 weeks; the dose achieved at 40 weeks was considered the maintenance dose.
• Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Baseline through the 2-year primary endpoint ]
  This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
• Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid [ Time Frame: 4 years (48 months) ]
  Tolerance Assessment: Participants in the Egg OIT treatment arm who were not tolerant at 2 years were offered an additional 2 years of therapy. A 10,000 mg double-blind placebo controlled oral food challenge to egg was done the same way as the one performed at 2 years for these participants in order to identify tolerant individuals in the 2 to 4 year extension segment. The tolerant individuals from this segment were then added to the tolerant individuals from the 2 year segment.

Original Secondary Outcome:

• Percent of participants who consume without symptoms 5,000 mg of egg white solid following the desensitization phase of the study
• Percent of participants who successfully complete the initial escalation to 50 mg of egg white solid OIT
• percent of participants who achieve the 2,000 mg dose of egg white solid OIT during the desensitization phase of the study
• Incidence of all serious adverse events

Dates:
Date Received: April 16, 2007
Date Started: May 2007
Date Completion:
Last Updated: September 15, 2016
Last Verified: September 2016