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Peanut Oral Immunotherapy in Children

NCT01867671 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2020-03-16

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26 weeks.

Conditions

  • Peanut Hypersensitivity

Interventions

BIOLOGICAL

Peanut Oral Immunotherapy - Liquid Extract

Used during initial dose escalation for doses 0.1 to 0.8 mg.

BIOLOGICAL

Placebo for Peanut Oral Immunotherapy - Liquid Extract form

Similar in appearance, texture, and taste to peanut liquid extract.

BIOLOGICAL

Peanut Oral Immunotherapy - Peanut Flour

This will be used for the remainder of dose escalation, build-up, and maintenance.

BIOLOGICAL

Placebo for Peanut Oral Immunotherapy - Peanut Flour

Similar in appearance, texture, and taste to peanut flour.

Sponsors & Collaborators

  • Immune Tolerance Network (ITN)

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Wesley Burks, MD · UNC Chapel-Hill

  • Stacie M. Jones, MD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-13
Primary Completion
2018-07-02
Completion
2018-12-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867671 on ClinicalTrials.gov