Preventing Anaphylaxis With Acalabrutinib

Food Allergy Clinical Trial

Official title: Preventing Life-Threatening Allergic Reactions With Acalabrutinib, an FDA-Approved Bruton's Tyrosine Kinase Inhibitor

Status Completed

Clinical Trial Summary

Food allergy is a potentially life-threatening condition, and its prevalence continues to increase despite public health efforts. There are currently no known therapies that can reliably prevent food-induced anaphylaxis. This is an open-label study designed to determine the ability acalabrutinib to prevent signs and symptoms of anaphylaxis during an oral food challenge in food-allergic adults.

Clinical Trial Description

Approximately 15 million people (including 8% of children) in the US have a food allergy and are at risk for life-threatening systemic reactions to foods. There is an unmet need for treatments capable of preventing such reactions. This is a phase II, single-center, open label trial involving the use of acalabrutinib (brand name Calquence®) to prevent food-induced anaphylaxis in adults with food allergy. Acalabrutinib is FDA-approved to treat certain medical conditions, but it is not approved to treat allergies.

Adult participants with a physician-diagnosed food allergy to peanut and/or tree nuts will be enrolled. These participants will undergo an oral food challenge to peanut or a tree nut under close physician supervision to determine participants' baseline reactivity. After a rest period, the participants will take 4 oral doses of acalabrutinib 100 mg, and then repeat the oral food challenge to see if acalabrutinib will reduce participants' reactivity to peanut or tree nuts. ;

Related Conditions & MeSH terms

• Anaphylaxis
• Food Allergy
• Food Allergy Peanut
• Food Hypersensitivity
• Hypersensitivity
• Peanut Hypersensitivity

• NCT number: NCT05038904
• Study type: Interventional
• Source: Johns Hopkins University
• Status: Completed
• Phase: Phase 2
• Start date: December 16, 2021
• Completion date: December 31, 2022