Phase 2
N=37
Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study
Food Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT00932828 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Determine the Percentage of Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC). — 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Peanut oral immunotherapy (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine the Percentage of Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC). |
29 | — |
| SECONDARY Determine the Percentage of Subjects Who Demonstrate Desensitization by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC). |
30 | — |
| SECONDARY Determine the Frequency of Treatment-related Adverse Effects (TAE) From Peanut OIT. |
0.8 | — |
Summary
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit young subjects who have recently been diagnosed with peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).
Eligibility Criteria
Inclusion Criteria
- Age 9-36 months of either sex, any race, any ethnicity at the time of the initial visit
- EITHER a positive skin prick test to peanuts or in vitro [CAP-FEIA] peanut immunoglobin E (IgE) level in the blood > 0.35 kU/L PLUS a history of a clinical allergic reaction (defined as significant clinical symptoms occurring within 60 minutes after ingesting peanuts) within 6 months of screening
- OR a positive prick skin test to peanuts and in vitro [CAP-FEIA] peanut IgE level > 5 kU/L when there is no history of allergic reaction and no known peanut exposure
- Provision of signed informed consent
- Development of symptoms characteristic of IgE-mediated food allergy (urticaria, angioedema, respiratory distress/wheeze/cough, vomiting/diarrhea, anaphylaxis) during initial oral food challenge
Exclusion Criteria
- History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise
- Currently participating in a study using an investigational new drug
- Participation in any interventional study for the treatment of food allergy in the past 12 months
- Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat
- Severe atopic dermatitis
- Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines
- Inability to discontinue antihistamines for skin testing and OFCs
Data sourced from ClinicalTrials.gov (NCT00932828). 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.