Clinical Trials

Inclusion Criteria:

1. Provide freely signed informed consent and assent (as applicable) and be willing to
comply with all study visits and requirements through end of study, including the
follow-up period.

2. Subjects aged ≥12 years for eligible regions; otherwise ≥18 years

3. Confirmed diagnosis of large duct or small duct PSC based on American Association for
the Study of Liver Disease (AASLD) guidelines.

4. Pruritus associated with PSC as assessed by Adult ItchRO.

5. Ursodeoxycholic acid (UDCA) and anti-pruritic medication use will be allowed if
meeting additional criteria.

6. Concomitant Inflammatory Bowel Disease (IBD) is allowed if meeting additional
criteria.

Exclusion Criteria:

1. Pruritus associated with an etiology other than PSC

2. Evidence or clinical suspicion of decompensated cirrhosis, or a history of
decompensation events

3. History of ileostomy or small bowel surgery/resection or other surgeries that may have
disrupted the enterohepatic circulation

4. Evidence, history, or suspicion of other liver diseases

5. Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation
procedure of a stricture within 12 weeks of Screening

6. Exceeding pre-defined biochemical values for alanine aminotransferase/aspartate
aminotransferase (ALT/AST), estimated glomerular filtration rate (eGFR),serum
creatinine (sCr), platelet count, international normalized ratio (INR) and total
bilirubin

7. History of liver transplantation

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/28/2024. Questions regarding updates should be directed to the study team contact.