Phase 2 N=60 Randomized Triple-blind Treatment

A Study of Sublingual Immunotherapy in Peanut-allergic Children

Food Hypersensitivity

Bottom Line

View on ClinicalTrials.gov: NCT00597727 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing — 45.5; 0; 11.8; 66.7 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Peanut SLIT (Drug); Placebo SLIT (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing	45.5; 0; 11.8; 66.7	—
SECONDARY Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing	26.1; 28.6; 0	—

Summary

The specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children.

Eligibility Criteria

Inclusion Criteria

Peanut IgE > 7kU/L (> 2kU/L for children aged 2 years and under) AND
History of significant clinical symptoms within 60 minutes after the ingestion of peanuts.

Exclusion Criteria

History of severe life-threatening anaphylaxis to peanut, OR
Medical history that would prevent a DBPCFC to peanut, OR
Subjects with wheat or oat allergy (which are used in the placebo), OR
Unable to cooperate with challenge procedures, OR
Unable to be reached by telephone for follow-up

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00597727). 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.