Preventing Anaphylaxis With Acalabrutinib

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: AstraZeneca
• Treatments: Acalabrutinib

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