STEP-IT-UP - Peanut Allergy Study for Infants

Study Overview
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Brief Summary
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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.

Official Title
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Subthreshold Peanut in Infants - Understanding Plasticity

Conditions
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Peanut Allergy, Food Allergy

Intervention / Treatment
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* Biological: Peanut powder or peanut butter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children age 4-14 months suspected to be peanut allergic Exclusion Criteria: Significant medical problems

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 14 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Open label, randomized trial (1:1) to either dietary peanut intake or strict avoidance prior to a double blind placebo controlled food challenge 52 weeks later.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary Peanut<br>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<br>* Commercially available peanut powder or peanut butter.<br>|
| No Intervention: Strict avoidance<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant food allergy, treatment study, peanut allergy treatment, increase threshold of peanut intake for peanut allergic children