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Preventing Anaphylaxis With Acalabrutinib

CompletedPhase 2

Sponsor: Johns Hopkins University

Conditions: Food Allergy, Food Allergy Peanut

Interventions: Acalabrutinib

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Baltimore, Maryland, United States