Preventing Anaphylaxis With Acalabrutinib (NCT05038904) | Clinical Trial Compass
CompletedPhase 2
Preventing Anaphylaxis With Acalabrutinib
United States10 participantsStarted 2021-12-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 i…
What they're measuring
1
Highest Dose of Peanut That is Tolerated During Oral Food Challenge