NCT01084174

A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy.

Detailed description

To effectively address the Primary Objectives of this pilot study, 30 subjects aged 6-21 years with: (1) a convincing clinical history of peanut allergy (PA), (2) a serum immunoglobulin E (IgE) specific to peanut of \>0.35 kilo units per liter (kU/L) and a skin prick test (SPT) wheal \>3 mm, will be enrolled. Subjects will be recruited from the Johns Hopkins Pediatric Allergy Clinic. Participants will undergo an initial screening visit that will include a medical history, physical exam, skin testing, and phlebotomy. Informed consent and assent will be obtained. At the next two visits, 20 participants will complete a double-blind placebo-controlled food challenge (DBPCFC). Eligible subjects will be randomized in a 1:1 ratio into two groups. One group will receive active SLIT with placebo OIT and the other group will begin active OIT with placebo SLIT dose escalation. Over the next 16 weeks of the study, subjects will undergo SLIT and OIT dose increases. A maintenance dose will then be taken at home daily for 12 months. A DBPCFC will be completed after 6 months and 12 months of home dosing. Those patients who pass the DBPCFC will be taken off SLIT and OIT for 4 weeks. A final challenge will be administered at the end of this period. Ten additional peanut-allergic subjects age 6-21 years will be enrolled and followed as longitudinal controls for the mechanistic studies. These subjects will follow a modified schedule compared to those subjects receiving study treatment and will be evaluated by phlebotomy, end point titration prick skin testing, and saliva collection. These patients will continue strict avoidance of peanut unless otherwise advised by their personal physician.

Conditions

• Peanut Hypersensitivity
• Food Hypersensitivity
• Immediate Hypersensitivity

Interventions

Type	Name	Description
DRUG	Peanut powder	Delivered orally
DRUG	Peanut extract	Delivered sublingually
DRUG	Placebo extract	Delivered sublingually
DRUG	Placebo powder	Delivered orally

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-01-01
• Completion: 2013-01-01
• First posted: 2010-03-10
• Last updated: 2017-04-07
• Results posted: 2017-04-07

Locations

1 site across 1 country: United States