NCT03149315

Inhibition of Anaphylaxis by Ibrutinib

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II open label study on the use of Ibrutinib on the inhibition of food-induced anaphylaxis in adults with food allergy. Ibrutinib (brand name Imbruvica) is currently FDA approved for the treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenstrom's macroglobulineia (WM). We propose to administer this approved drug to adults with food allergy to inhibit food allergy responses.

Detailed description

This is open-label study designed to determine the fewest doses and shortest length of time, from two days to up to 7 days, needed for ibrutinib to fully inhibit tests for food allergy, and to determine the length of persistence of efficacy after the drug is stopped.

Conditions

• Food Allergy
• Anaphylaxis Food

Interventions

Type	Name	Description
DRUG	Ibrutinib	Ibrutinib 420mg, PO once daily for 2-7 days

Timeline

• Start date: 2017-04-10
• Primary completion: 2018-11-14
• Completion: 2018-11-14
• First posted: 2017-05-11
• Last updated: 2025-01-17
• Results posted: 2025-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study