NCT03907397

Immune Basis and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy

Challenging to Food With Escalating Thresholds for Reducing Food Allergy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Scott Sicherer · Academic / Other
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine whether allowing ingestion of sub-threshold amounts of peanut in those with a high threshold (tolerate at least 143 mg peanut protein on supervised double-blind, placebo-controlled oral food challenge \[DBPCFC\]) will be associated with attaining even higher thresholds over time in children with high threshold peanut allergy compared to those avoiding peanut. The secondary clinical objectives include assessing the development of sustained unresponsiveness (SU, a surrogate term for tolerance without daily ingestion), effects on quality of life, and safety compared to those avoiding peanut. Additionally, this study will phenotype the allergic response to peanut based on threshold and response to exposure. Mechanistic study objectives will determine the immune and molecular basis of the high threshold endotype, identify predictors of response to exposure, and determine mechanisms and biomarkers of remission.

Conditions

• Food Allergy
• Peanut Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Peanut Protein	up to 3 level teaspoons peanut butter or equivalent (approximately 3400 mg)
OTHER	Continued peanut avoidance	Standard of care avoidance of peanut

Timeline

• Start date: 2019-08-05
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2019-04-09
• Last updated: 2025-02-07
• Results posted: 2025-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study