A Study of Sublingual Immunotherapy in Peanut-allergic Children

Phase 2

Completed

• Conditions: Food Hypersensitivity
• Interventions: Drug: Peanut SLIT; Drug: Placebo SLIT

• Registration Number: NCT00597727
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

In spite of increased recognition and understanding of food allergies, food-induced anaphylaxis remains the single most common cause of anaphylaxis seen in hospital emergency departments, accounting for about one third of anaphylaxis cases seen. It is estimated that about 30,000 food-induced anaphylactic events are seen in U.S. emergency departments each year and that about 200 fatal cases occur in the U.S. each year. Either peanuts or tree nuts cause more than 80% of these reactions. No treatments are available and avoidance is the only approved intervention.

The goal of this study is to investigate peanut sublingual immunotherapy (SLIT) as a treatment for children with peanut allergy. This study is primarily designed to evaluate the efficacy and safety of peanut SLIT compared to placebo after 12 months. Secondarily, the study is designed to evaluate the efficacy of extended maintenance dosing of peanut SLIT in inducing lasting tolerance after discontinuation of the peanut SLIT. Mechanistic studies will be completed concurrently as exploratory endpoints to understand changes in the allergic immune response related to peanut SLIT.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-18
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2017-02-07
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-07
• Results First Posted: 2017-05-18
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ext. maint. open label peanut SLIT	Peanut SLIT	After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
Early unblinded peanut SLIT	Peanut SLIT	Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
Blinded Peanut SLIT	Peanut SLIT	Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
Blinded Placebo SLIT	Placebo SLIT	Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
Pilot peanut SLIT rollover cohort	Peanut SLIT	Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing	12 months	Upon completion of 12 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 2500 mg peanut protein DBPCFC without developing symptoms after 12 months of peanut SLIT therapy.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing	36-60 months	Upon completion of 36-60 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. Peanut SLIT therapy was then discontinued for 2-4 weeks to assess for persistence of the desensitization response called sustained unresponsiveness (SU). The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5000 mg peanut protein DBPCFC without developing symptoms 2-4 weeks after discontinuing peanut SLIT therapy.

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States