Phase 2
N=92
Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy
Food Allergy
Bottom Line
View on ClinicalTrials.gov: NCT01846208 ↗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
| Outcome | Result | p-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
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.