A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

Inclusion Criteria:

• Provide signed informed consent at the screening visit as well as comply with allstudy visits and requirements through the end of the study

• Male or female, age ≥18 years at the screening visit

• Confirmed diagnosis of PBC in line with the AASLD guidelines

• UDCA and anti-pruritic medication use will be allowed if meeting additional criteria

• Qualified pruritus associated with PBC as assessed by Adult ItchRO

Exclusion Criteria:

• Pruritus associated with an etiology other than PBC

• Evidence or clinical suspicion of decompensated cirrhosis or a history ofdecompensation events

• Current symptomatic cholelithiasis or inflammatory gallbladder disease

• History of small bowel surgery/resection impacting the terminal ileum that maydisrupt the enterohepatic circulation.

• Evidence, history, or suspicion of other liver diseases; PBC patients with AIH arenot excluded

• History of Liver transplantation