Preventing Anaphylaxis With Acalabrutinib
Condition: Food Allergy; Food Allergy Peanut
MeSH terms: Hypersensitivity; Food Hypersensitivity; Anaphylaxis; Peanut Hypersensitivity
Intervention: Acalabrutinib
Intervention description: 100 mg oral capsule
Intervention MeSH terms: Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anaphylaxis; Peanut allergy; Tree nut allergy; Hypersensitivity

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.
    

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