STEP-IT-UP - Peanut Allergy Study for Infants

Subthreshold Peanut in Infants - Understanding Plasticity

Multicenter randomized (1:1) trial of strict avoidance versus sub-threshold dietary introduction of peanut in peanut allergic infants 4-14 months of age who react at a minimum cumulative dose of at least 430 mg of peanut protein at initial oral food challenge (OFC) for 12 months, followed by cross-over to sub-threshold dietary introduction of peanut in those randomized initially to avoidance.

Study Overview

• Status: Withdrawn
• Conditions: Peanut Allergy; Food Allergy
• Intervention / Treatment: Biological: Peanut powder or peanut butter

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children age 4-14 months suspected to be peanut allergic

Exclusion Criteria:

• Significant medical problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Dietary Peanut; Participants in this group will be asked to continue peanut in their diet for 1 year at a dose determined from the double blind placebo controlled food challenge at baseline. After the 1 year period, participants will be given another double blind placebo controlled food challenge which will be used to determine their current peanut threshold. The current peanut threshold will be used to determine which participants will go into clinical care and which will get sustained unresponsiveness food challenges to peanut.	Biological: Peanut powder or peanut butter; Commercially available peanut powder or peanut butter.
NO_INTERVENTION: Strict avoidance; Participants in this group will be asked to strictly avoid any peanut in their diet for 1 year. After the 1 year period, participants will be given another double blind placebo controlled food challenge which will be used to determine whether they will transition to daily dietary peanut or continue with clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral food challenge threshold to peanut at week 52	compare the oral food challenge threshold (in milligrams) to peanut during a double-blind placebo-controlled food challenge (DBPCFC) after 12 months between subjects randomized to dietary peanut introduction and those randomized to avoidance.	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Oral food challenge threshold to peanut at week 52 for those initially randomized to dietary peanut compared to the oral food challenge threshold at week 104 for those initially randomized to strict avoidance	Compare the oral food challenge threshold (in milligrams) to peanut during a double-blind placebo-controlled food challenge (DBPCFC) after 12 months of dietary peanut between subjects randomized to dietary peanut introduction first and those randomized to avoidance for 52 weeks and subsequent dietary peanut after week 52.	104 weeks
Oral food challenge threshold at 1 month avoidance after 12 months in each treatment group	Comparison of OFC threshold (in milligrams) at 1 month of avoidance (sustained unresponsiveness) after 12 months of dietary peanut between those initially randomized to peanut and those randomized to delayed introduction.	56 weeks
Oral food challenge threshold at 2 months avoidance after 12 months in each treatment group	Comparison of OFC threshold (in milligrams) at 2 months of avoidance (sustained unresponsiveness) after 12 months of dietary peanut between those initially randomized to peanut and those randomized to delayed introduction.	60 weeks
Safety with dietary introduction of peanut or avoidance	Number of participants who have severe (grade 3) anaphylaxis secondary to any DBPCFC or ingestion of the measured dose of peanut.	52 weeks
Rate of discontinuation of dietary peanut	Number of participants randomized to dietary peanut who discontinue peanut.	104 weeks
Severity of eczema as assessed by the Scoring Atopic Dermatitis (SCORAD) score	Eczema severity as assessed by the SCORAD. The SCORAD has a component for patient measured outcomes and also provider assessment of eczema involvement. It has an overall score range of 0-100, where higher scores signify more severe eczema.	104 weeks
Peanut skin prick test wheal size	Average wheal size (millimeters) of peanut skin prick test for participants in each group.	104 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Corinne Keet, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2021
• Primary Completion (ANTICIPATED): November 1, 2026
• Study Completion (ANTICIPATED): November 1, 2028

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (ACTUAL): February 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: treatment study; infant food allergy; peanut allergy treatment; increase threshold of peanut intake for peanut allergic children
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: IRB00279285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant level data will be shared. Only aggregate data from the study will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No