Phase 2
N=10
Oral Immunotherapy for Peanut Allergy (PMIT)
Food Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT00597675 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing Treatment With Peanut OIT. — 5000 mg of peanut protein
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Peanut OIT (Biological); Placebo (Biological)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing Treatment With Peanut OIT. |
5000 | — |
| SECONDARY The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing 12 Months of Blinded Peanut OIT or Placebo Treatment. |
123; 4710 | — |
| SECONDARY The Change From Baseline Through the End of Peanut OIT Treatment in Wheal Size Diameter Following Peanut Skin Prick Testing |
-4.5 | — |
| SECONDARY The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgE in the Blood |
-187 | — |
| SECONDARY The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgG4 in the Blood. |
6.6 | — |
Summary
The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects who have peanut allergy less allergic and induce changes in their immune system.
Eligibility Criteria
Inclusion Criteria
- Subject between 1 and 18 years of age
- EITHER history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts greater than 6 months ago AND peanut specific IgE >15 kU/L
- OR history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts within the past 6 months AND peanut specific IgE > 7 kU/L
- A family that will be able to be compliant with all study visits
- All females of child bearing age must be using appropriate birth control
Exclusion Criteria
- Subjects with a history of severe, anaphylaxis to peanut
- Medical history that would prevent a double blind placebo controlled oral food challenge (DBPCFC/OFC) to peanut
- Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
- Diagnosed oat allergy
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT00597675). 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.