Clinical Trial Finder

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

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.

Arms

Experimental: Acalabrutinib

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

Interventions

Drug: - Acalabrutinib

100 mg oral capsule