Back to resultsSTEP-IT-UP - Peanut Allergy Study for Infants
Primary Purpose
Peanut Allergy, Food Allergy
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Peanut powder or peanut butter
Sponsored by
About this trial
This is an interventional treatment trial for Peanut Allergy focused on measuring infant food allergy, treatment study, peanut allergy treatment, increase threshold of peanut intake for peanut allergic children
Eligibility Criteria
Inclusion Criteria:
- Children age 4-14 months suspected to be peanut allergic
Exclusion Criteria:
- Significant medical problems
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Dietary Peanut
Strict avoidance
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Rate of discontinuation of dietary peanut
Number of participants randomized to dietary peanut who discontinue peanut.
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.
Peanut skin prick test wheal size
Average wheal size (millimeters) of peanut skin prick test for participants in each group.
Full Information
NCT ID
NCT04761835
First Posted
February 16, 2021
Last Updated
November 9, 2021
Sponsor
Johns Hopkins University
Collaborators
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT04761835
Brief Title
STEP-IT-UP - Peanut Allergy Study for Infants
Official Title
Subthreshold Peanut in Infants - Understanding Plasticity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn in IRB
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy, Food Allergy
Keywords
infant food allergy, treatment study, peanut allergy treatment, increase threshold of peanut intake for peanut allergic children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary Peanut
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Strict avoidance
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Peanut powder or peanut butter
Intervention Description
Commercially available peanut powder or peanut butter.
Primary Outcome Measure Information:
Title
Oral food challenge threshold to peanut at week 52
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
104 weeks
Title
Oral food challenge threshold at 1 month avoidance after 12 months in each treatment group
Description
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.
Time Frame
56 weeks
Title
Oral food challenge threshold at 2 months avoidance after 12 months in each treatment group
Description
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.
Time Frame
60 weeks
Title
Safety with dietary introduction of peanut or avoidance
Description
Number of participants who have severe (grade 3) anaphylaxis secondary to any DBPCFC or ingestion of the measured dose of peanut.
Time Frame
52 weeks
Title
Rate of discontinuation of dietary peanut
Description
Number of participants randomized to dietary peanut who discontinue peanut.
Time Frame
104 weeks
Title
Severity of eczema as assessed by the Scoring Atopic Dermatitis (SCORAD) score
Description
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.
Time Frame
104 weeks
Title
Peanut skin prick test wheal size
Description
Average wheal size (millimeters) of peanut skin prick test for participants in each group.
Time Frame
104 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
14 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children age 4-14 months suspected to be peanut allergic
Exclusion Criteria:
Significant medical problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Keet
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant level data will be shared. Only aggregate data from the study will be shared.
Learn more about this trial
STEP-IT-UP - Peanut Allergy Study for Infants
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