Phase 2
N=16
Oral Immunotherapy (OIT) for Peanut Allergy
Peanut Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT00815035 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy. — 89 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Peanut OIT (Drug); Placebo (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy. |
89 | — |
| SECONDARY The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of Peanut OIT Therapy. |
100 | — |
| SECONDARY The Percentage of Subjects Who Tolerated the Initial-day Escalation to 6 mg of Peanut |
90; 100; 100 | — |
| SECONDARY The Percentage of Subjects Who Are Successfully Able to Escalate up to the 4000 mg Maximum Maintenance Dose of Peanut Protein OIT During the 60 Month Desensitization Phase of the Study |
90; 100; 66.7 | — |
| SECONDARY Incidence of All Serious Adverse Events During the Study |
0; 0; 0 | — |
Summary
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit subjects who have 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 1- 6 years all of either sex, any race, any ethnicity at the time of the initial visit
- The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal >3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L
- A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts
- Provide signed informed consent
Exclusion Criteria
- History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or oxygen saturation < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
- 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
- Poor control or persistent activation of atopic dermatitis
- Moderate to severe persistent asthma
- 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 oral food challenges (OFCs)
Data sourced from ClinicalTrials.gov (NCT00815035). 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.