Phase 2 N=556 Treatment

Persistence of Oral Tolerance to Peanut

Eczema · Egg Allergy · Food Allergy · Hypersensitivity

Bottom Line

View on ClinicalTrials.gov: NCT01366846 ↗

Enrolled (actual)

556

Serious AEs

4.3%

Results posted

Jan 2017

Primary outcome: Primary: Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum — 34; 7; 18; 6 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Avoidance of peanut (Other)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum	34; 7; 18; 6	<0.001 sig
PRIMARY Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group	52; 13	<0.001 sig
PRIMARY Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum in the Per Protocol Population	34; 7; 18; 6	<0.001 sig
PRIMARY Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group in the Per Protocol Population	52; 13	<0.001 sig
SECONDARY Number of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group	10; 13	0.250
SECONDARY Number of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population	10; 13	0.250

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.

Eligibility Criteria

Inclusion Criteria

All LEAP Study participants who are evaluable for peanut allergy at year 5 by LEAP (ClinicalTrials.gov ID NCT00329784) Study criteria.
Parent or guardian willing to provide informed consent.

Exclusion Criteria

Unable or unwilling to comply with study intervention and procedures.
Participation in other food allergy intervention trials.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01366846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.