NCT04761835

STEP-IT-UP - Peanut Allergy Study for Infants

Subthreshold Peanut in Infants - Understanding Plasticity

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 4 Months – 14 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Peanut powder or peanut butter	Commercially available peanut powder or peanut butter.

Timeline

• Start date: 2021-11-01
• Primary completion: 2026-11-01
• Completion: 2028-11-01
• First posted: 2021-02-21
• Last updated: 2021-11-17

Regulatory

• FDA-regulated drug study