Clinical Research Directory

Inclusion Criteria: * Male or female participant who has a PBC diagnosis as demonstrated by the presence of ≥2 of the following three diagnostic criteria: * History of ALP above ULN for at least 6 months * History of positive antimitochondrial antibody (AMA) titer or positive PBC-specific antinuclear antibody (ANA) titer * Historical liver biopsy consistent with PBC * Participant has the following qualifying biochemistry value at Screening: * ALP ≥1.5 × ULN * Participant is ≥18 years of age at consent. * Participant meets all other eligibility criteria outlined in the Clinical Study Protocol. Exclusion Criteria: * Participant meets any one of the following criteria at Screening: * ALP\>10 × ULN * ALT or AST \>5 × ULN * Hepatitis C treatment within 5 years of Screening, or active hepatitis C as defined by positive hepatitis C antibody with the presence of hepatitis C virus ribonucleic acid; subjects with active hepatitis B (HBV) infection (hepatitis B surface antigen \[HbsAg\] positive) will be excluded. A subject with resolved hepatitis A at least 3 months prior to the Screening Visit can be screened. * Primary sclerosing cholangitis and secondary sclerosing cholangitis (eg, due to cholangiolithiasis, ischemia, telangiectasia, vasculitis, infectious diseases) * Alcoholic liver disease * History of definite autoimmune hepatitis or PBC/autoimmune hepatitis overlap, defined as both of the following: 1) IgG \>2 × ULN and/or positive anti-smooth muscle antibodies, 2) liver histology revealing moderate or severe periportal or periseptal inflammation * Nonalcoholic steatohepatitis (NASH) * Gilbert's Syndrome * Alpha-1-antitrypsin deficiency, cystic fibrosis, Wilson's disease, hemochromatosis based on historically established diagnosis * Drug-induced liver injury (DILI) as defined by typical exposure and history * Known condition that involves bile duct obstruction or cholestasis other than PBC, eg, vascular diseases (eg, Budd-Chiari syndrome, sinusoidal obstruction syndrome, congestive hepatopathy), congenital conditions (ductal plate malformations, Caroli syndrome, congenital liver fibrosis), idiopathic ductopenia * Hepatocellular carcinoma * Participant meets any other exclusion criteria outlined in the Clinical Study Protocol.