Primary endpoint.
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The predetermined primary endpoint was the change in patients’ threshold dose of ingested peanut protein to elicit an objective clinical reaction during OFC after acalabrutinib pretreatment compared with patients’ baseline. At baseline, patients tolerated a median of 29 mg of peanut protein (range, 1–444) before experiencing an objective clinical reaction during OFC. If needed, all patients were treated with intramuscular epinephrine for their reaction per standard of care in addition to adjunct therapies (e.g., antihistamines or albuterol) at the discretion of the investigator; a summary of rescue medications that were administered to patients during their baseline OFC is listed in 