Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension

Key Inclusion Criteria: Screening period up to liver transplantation: * Written informed consent obtained before any assessment. * Male or female patients between 18 to 70 years of age. * Recipients of a primary liver transplant from a deceased donor. * Up to date vaccination as per local immunization schedules. * Recipients tested negative for HIV. * MELD score ≤ 30. * Transplantation to occur within defined screening period following informed consent signature. At randomization (Day 8 +/- 2): * Recipients with no active HCV and HBV replication. * Allograft is functioning at an acceptable level by the time of randomization as defined by AST, ALT and Alkaline Phosphatase levels ≤ 5 times ULN and Total Bilirubin ≤ 2 times ULN. * Renal function (eGFR, MDRD-4 formula) ≥ 30 mL/min/1.73 m2 based on most recent post-transplant value prior to randomization. * Recipients who have been initiated on an immunosuppressive regimen that contains TAC, mycophenolate mofetil (MMF) and corticosteroids (CS) as per protocol. Key Exclusion Criteria: Screening period up to liver transplantation: * Use of other investigational drugs at screening within 30 days or 5 half-lives of screening. * Recipients of multiple solid organ or islet cell transplants, or recipients that have previously received a tissue transplant, or a combined liver-kidney transplant. * Recipients of a liver from a donor after cardiac death (DCD), from a living donor, or of a split liver. * Recipient who tested negative f…