Inhibition of Anaphylaxis by Ibrutinib

NCT03149315 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2016-357
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Allergy; Anaphylaxis Food

Outcome Measures

Primary Outcomes (1)

• Number of Doses of Ibrutinib for Maximal Suppression of Skin Prick Test Size to Foods

  The primary outcome was the number of ibrutinib doses (2, 4, or 7 doses) required to maximally suppress food skin prick reactivity to foods. All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria. Skin testing to peant and tree nuts was done at baseline and repeated at each visit on days 2, 4, and 7 (corresponding to 2, 4, or 7 doses of ibrutinib).

  7 days

Secondary Outcomes (2)

• Number of Doses of Ibrutinib for Maximal Suppression of Basophil Reactivity

  7 days

• Time to Recovery of Skin Test Reactivity

  30 days

Study Arms (1)

Open Label Administration

EXPERIMENTAL

Allergic subjects will be given ibrutinib 420mg daily for 2-7 doses to determine the shortest amount of time and fewest ibrutinib doses required to suppress food skin prick testing and basophil activation test reactivity.

Drug: Ibrutinib

Interventions

Ibrutinib DRUG

Ibrutinib 420mg, PO once daily for 2-7 days

Also known as: Ibruvica

Open Label Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Women of child bearing potential must agree to two forms of highly effective contraception (hormonal, device, or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the Principal Investigator and her treating physician immediately.
• A female of child bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Northwestern University Feinberg School of Medicine: collaborator

Study Sites (1)

Ann & Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Dispenza MC, Pongracic JA, Singh AM, Bochner BS. Short-term ibrutinib therapy suppresses skin test responses and eliminates IgE-mediated basophil activation in adults with peanut or tree nut allergy. J Allergy Clin Immunol. 2018 May;141(5):1914-1916.e7. doi: 10.1016/j.jaci.2017.12.987. Epub 2018 Jan 31. No abstract available.

  PMID: 29360526 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Melanie Dispenza, MD, PhD
• Organization: Johns Hopkins University School of Medicine

mdispen1@jhmi.edu

410-550-1815

Study Officials

• Anne Marie Singh, MD

  Ann & Robert H. Lurie Childrens Hospital

  PRINCIPAL INVESTIGATOR

• Bruce Bochner, MD

  Northwestern Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 11, 2017
• Study Start: April 10, 2017
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)