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Inhibition of Anaphylaxis by Ibrutinib | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Inhibition of Anaphylaxis by Ibrutinib

NCT03149315•Ann & Robert H Lurie Children's Hospital of Chicago

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•History of food allergy to peanut (or tree nut).
•Male or female age ≥ 18 years.
•Positive skin prick testing and basophil activation test to the trigger food, either peanut or tree nut.
•Adequate organ and marrow function as defined below:
•leukocytes ≥ 3,000/mcL
•absolute neutrophil count ≥ 1,500/mcL
•platelets ≥ 100,000/mcl
•total bilirubin within normal institutional limits
•AST(SGOT)/ALT(SPGT) within normal institutional limits
•Creatinine within normal institutional limits
+6 more criteria

Exclusion Criteria

•Subjects who have been on immunomodulatory therapies or oral corticosteroids within 1 month prior to study participation will be excluded, and those taking antihistamines must stop these drugs for one week prior to enrollment and must refrain from taking antihistamines during the duration of the study so as not to interfere with SPT responses.
•Subjects with symptoms not consistent with type 1 food reactions (atopic dermatitis, eosinophilic esophagitis and any other non-IgE-mediated food sensitivities) will be excluded.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib.
•Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, beta-blocker use or psychiatric illness/social situations that would limit compliance with study requirements.
•Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
•Subjects on anticoagulants, anti-platelet therapy, or any other predisposition towards bleeding.

Locations (1)

Ann & Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

April 10, 2017

Primary Completion Date

November 14, 2018

Completion Date

November 14, 2018

Last Updated

January 17, 2025

Enrollment

ACTUAL participants

Conditions

Food AllergyAnaphylaxis Food

Interventions

Ibrutinib

DRUG

Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders

NCT00267501

Eosinophilic Gastrointestinal Disease Eosinophilic Inflammatory DiseaseFood Allergy

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RECRUITINGNA

Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg

NCT06260956

Allergy and ImmunologyPeanut and Nut Allergy+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Inhibition of Anaphylaxis by Ibrutinib

Inclusion Criteria

Exclusion Criteria

Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders

Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg

Evaluation of The Food Allergy Mastery Program

Effect of Omalizumab in the Skin of Food Allergy Patients

The NACHO Trial (Nut Allergy Children OIT)

EPAP, Interviewstudy