STEP-IT-UP - Peanut Allergy Study for Infants

NCT04761835 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: IRB00279285
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peanut Allergy; Food Allergy

Keywords

infant food allergy; treatment study; peanut allergy treatment; increase threshold of peanut intake for peanut allergic children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  104 weeks

• Oral food challenge threshold at 1 month avoidance after 12 months in each treatment group

  56 weeks

• Oral food challenge threshold at 2 months avoidance after 12 months in each treatment group

  60 weeks

• Safety with dietary introduction of peanut or avoidance

  52 weeks

• Rate of discontinuation of dietary peanut

  104 weeks

Study Arms (2)

Dietary Peanut

ACTIVE COMPARATOR

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

Strict avoidance

NO INTERVENTION

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.

Interventions

Peanut powder or peanut butter BIOLOGICAL

Commercially available peanut powder or peanut butter.

Dietary Peanut

Eligibility Criteria

• Age: 4 Months - 14 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Significant medical problems

Sponsors & Collaborators

• Johns Hopkins University: lead
• Icahn School of Medicine at Mount Sinai: collaborator

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Corinne Keet

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: November 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share