Endpoints.
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SECONDARY
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 the patients’ baseline. A key secondary endpoint included the change in the severity of clinical reactions during OFC. Other secondary endpoints included size of the skin test wheal to peanut extract and the percent of basophils activated ex vivo by peanut extract while receiving acalabrutinib compared with baseline. Safety endpoints included electrocardiography and laboratory blood testing, including complete blood counts and differentials, serum chemistries, and liver function tests. Exploratory endpoints included changes in circulating quantitative immunoglobulins and serum-specific IgE to peanut and peanut components.