Preventing Anaphylaxis With Acalabrutinib

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.

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