Preventing Anaphylaxis With Acalabrutinib

NCT ID: NCT05038904

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-16
• Study Completion Date: 2022-12-31

Brief 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.

Detailed 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.

Conditions

Food Allergy; Food Allergy Peanut

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acalabrutinib

Participants will be given acalabrutinib (four doses of 100 mg of acalabrutinib to be taken orally twice daily).

Group Type: EXPERIMENTAL

Acalabrutinib

Intervention Type: DRUG

100 mg oral capsule

Interventions

Acalabrutinib

100 mg oral capsule

Intervention Type: DRUG

Other Intervention Names

Calquence

Eligibility Criteria

Inclusion Criteria

• History of immunoglobulin E (IgE)-mediated food allergy to peanut or tree nut
• Positive skin prick test to the trigger food (either peanut or tree nut)
• Objective clinical reaction to the food allergen during baseline oral food challenge
• 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 7 days following completion of acalabrutinib therapy.
• Ability to understand and the willingness to sign a written informed consent
• Ability to clearly understand and speak English at an 8th grade reading level

Exclusion Criteria

• Participants who have been on immunomodulatory therapies or oral corticosteroids within 1 month prior to enrollment
• Participants with symptoms consistent with food reactions other than type 1 hypersensitivity
• History of allergic reaction to acalabrutinib
• History of idiopathic urticaria, dermatographism, idiopathic or unexplained anaphylaxis, or anaphylaxis (to foods or otherwise) resulting in intubation, prolonged hypotension, or neurological sequelae- History of cardiovascular disease
• History of a bleeding disorder, or those currently taking blood thinners
• History of stroke
• History of gastrointestinal ulcer
• History of cancer (other than skin cancer)
• Positive HIV status or history of other immunodeficiency
• Active or latent Hepatitis B or C infection based on laboratory testing
• Currently pregnant or nursing
• Current use of proton pump inhibitors (Note: participants currently receiving proton pump inhibitors who switch to H2-receptor antagonists or other antacids are eligible for enrollment to this study).
• Active significant infection
• Major surgical procedure within 28 days of enrollment
• Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
• Difficulty swallowing oral medication, or significant gastrointestinal disease that would limit absorption of oral medication
• Concurrent participation in another therapeutic clinical trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melanie C. Dispenza, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

References

Suresh RV, Dunnam C, Vaidya D, Wood RA, Bochner BS, MacGlashan DW Jr, Dispenza MC. A phase II study of Bruton's tyrosine kinase inhibition for the prevention of anaphylaxis. J Clin Invest. 2023 Aug 15;133(16):e172335. doi: 10.1172/JCI172335.

Reference Type: RESULT

PMID: 37384412 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00223615

Identifier Type: -

Identifier Source: org_study_id