CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 556 enrolled
Drug / intervention
Avoidance of peanutother
Likely dose
Not stated in 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/NCT01366846
NCT01366846Phase 2Completed
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The Persistence of Oral Tolerance Induction to Peanut and Its Immunological Basis (ITN049AD)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 6, 2011·Updated Mar 10, 2017

In Brief

A Phase 2 clinical trial evaluating Avoidance of peanut for Eczema and 3 related conditions. Completed, enrolled 556 participants across 1 site.

Detailed Summary

ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784). Peanut Allergy, a recognized public health concern, is a common and potentially life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study evaluated whether early exposure to peanut promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the effect of twelve months of cessation of peanut consumption in LEAP Study participants who consumed peanut and those who avoided peanut over the previous five years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEczema, Egg Allergy, Food Allergy, Hypersensitivity
CountriesUnited Kingdom
CollaboratorsImmune Tolerance Network (ITN)

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 6, 2011
Enrollment StartMay 1, 2011
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 15.1 years ago

Interventions

Avoidance of peanutother

All participants will be assigned to peanut avoidance as per United Kingdom (UK) public health recommendations and will avoid exposure to peanut protein during the study until the last study visit when they will receive the Oral Food Challenge.