LOGICS had an open-label dose titration and maintenance phase for up to 19 weeks, followed by an 8-week double-blind, placebo controlled, randomized withdrawal phase and 8 weeks of restoration.1,2
The proportion of patients with mUFC normalization, defined as a patient with mUFC at or below the ULN at the end of randomized withdrawal phase without meeting a requirement for early rescue during the randomized withdrawal phase.
*Subjects eligible for the randomized-withdrawal phase achieved stable therapeutic dose (defined as the dose providing mUFC at or below the ULN, determined from 3 adequate 24-h urine collections) and maintained the dose associated with mUFC normalization for at least the final 4 weeks of the titration maintenance phase.2
†mUFC normalization was defined as patients with mUFC at or below the ULN at the end of the withdrawal phase without requiring early rescue during the randomized withdrawal phase.2
‡ Early rescue was allowed when a patient demonstrated relapse of hypercortisolemia (mUFC above 1.5x ULN); If early rescue was needed, patients immediately entered the restoration phase.
References: 1. RECORLEV [prescribing information]. Chicago, IL: Xeris Pharmaceuticals, Inc. 2. Pivonello R, Zacharieva S, Elenkova A, et al. Levoketoconazole in the treatment of patients with endogenous Cushing’s syndrome: a double-blind, placebo-controlled, randomized withdrawal study (LOGICS). Pituitary. 2022;25(6):911-926. doi:10.1007/s11102-022-01263-7
