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Phase 2 N=92 Randomized Treatment

Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy

Food Allergy

Enrolled (actual)
92
Serious AEs
1.1%
Results posted
Oct 2018
Primary outcome: Primary: Sustained Unresponsiveness to Egg Consumption at 2 Years. — 3; 10; 7 Participants — p=0.009

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Egg Oral Immunotherapy (Drug); Baked Egg (Drug)
Age
Pediatric · 3+ yrs
Sex
All
Sponsor
Hugh A Sampson, MD
Primary completion
Sep 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Sustained Unresponsiveness to Egg Consumption at 2 Years.
3; 10; 7 0.009 sig
SECONDARY
Desensitization to >= 4.444 Grams Egg White Solid.
8; 17; 22; 6; 20; 27 <0.0001 sig
SECONDARY
Incidence of All Serious Adverse Events
0; 0; 1
SECONDARY
Number of Participants With Unrestricted Consumption of Unbaked Egg
4; 14; 12 0.003 sig

Summary

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

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01846208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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