CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 146 enrolled
Drug / intervention
Peanut Oral Immunotherapy - Liquid Extract +3 morebiological
Likely dose
Peanut Oral Immunotherapy - Liquid Extract 0.8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01867671
NCT01867671Phase 2Completed

Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 4, 2013·Updated Mar 16, 2020

In Brief

A Phase 2 clinical trial evaluating Peanut Oral Immunotherapy - Liquid Extract, Placebo for Peanut Oral Immunotherapy - Liquid Extract form, and 2 other interventions for Peanut Hypersensitivity. Completed, enrolled 146 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 4, 2013
Enrollment StartAug 13, 2013
Primary CompletionJul 2, 2018
Study CompletionDec 21, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.1 years ago

Interventions

Peanut Oral Immunotherapy - Liquid Extractbiological

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

Placebo for Peanut Oral Immunotherapy - Liquid Extract formbiological

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

Peanut Oral Immunotherapy - Peanut Flourbiological

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

Placebo for Peanut Oral Immunotherapy - Peanut Flourbiological

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