preventing anaphylaxis with acalabrutinib

Conditions: Food Allergy; Food Allergy Peanut

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.

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.

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

Keywords: anaphylaxis peanut allergy tree nut allergy hypersensitivity