Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy

NCT01846208 | Completed Phase 2 Results DMC

• 3 other identifiers: GCO 04-1271U19AI066738CoFAR7
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Food Allergy

Keywords

Egg Allergy; Egg Oral Immunotherapy; Food Allergy

Outcome Measures

Primary Outcomes (1)

• Sustained Unresponsiveness to Egg Consumption at 2 Years.

  Sustained unresponsiveness - able to successfully consume 7444 mg egg white protein in a desensitization OFC and, after an 8-10 week egg-free interval, were also able to successfully consume 7444 mg egg white protein in an OFC after up to 2 years of therapy.

  2 Years

Secondary Outcomes (3)

• Desensitization to >= 4.444 Grams Egg White Solid.

  1 Year and 2 Years

• Incidence of All Serious Adverse Events

  up to 3 years

• Number of Participants With Unrestricted Consumption of Unbaked Egg

  3 years after randomization

Other Outcomes (1)

• Changes in Egg-specific Mechanistic Measures and Skin Prick Test Results.

  2 Years

Study Arms (3)

Egg OIT Randomized

EXPERIMENTAL

Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.

Drug: Egg Oral Immunotherapy

Baked Egg Randomized

EXPERIMENTAL

Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive baked egg in the form of home-baked goods and "safe" commercial products with up to four oral food challenges as directed by the protocol.

Drug: Baked Egg

Egg OIT Assigned

EXPERIMENTAL

Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.

Drug: Egg Oral Immunotherapy

Interventions

Egg Oral Immunotherapy DRUG

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.

Also known as: Egg white solid

Egg OIT Assigned; Egg OIT Randomized

Baked Egg DRUG

Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

Baked Egg Randomized

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.
• 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

Sponsors & Collaborators

• Hugh A Sampson, MD: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Consortium of Food Allergy Research: collaborator

Study Sites (5)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 100029, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• Study Web Site

MeSH Terms

Conditions

Food Hypersensitivity; Egg Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Hugh A. Sampson
• Organization: Icahn School of Medicine at Mount Sinai

hugh.sampson@mssm.edu

212-659-9426

Study Officials

• Hugh A Sampson, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

• Robert Wood, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Jaffe Food Allergy Institute

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: July 1, 2013
• Primary Completion: September 28, 2017
• Study Completion: September 30, 2018
• Last Updated: July 26, 2019
• Results First Posted: October 30, 2018

Record last verified: 2019-07

Locations

US (5)