Overview
This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)
Principal investigator
Eligibility criteria
Inclusion Criteria:
- Age 18 to 80 years
- Documented primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC)
- Presence of consistent moderate to severe pruritus
- Use of anti-pruritic and anti-cholestatic (including UDCA and obeticholic acid) medication allowed if meeting additional criteria
- Individuals with concomitant inflammatory bowel disease must meet additional relevant criteria
Exclusion Criteria:
- Pruritus associated with an etiology other than PBC or PSC
- Prior or planned liver transplantation
- Evidence of compensated or decompensated cirrhosis
- Alternative causes of liver disease
- Presence of documented secondary sclerosing cholangitis
- Current evidence of clinically significant high-grade strictures or presence of biliary stent
- History of significant small bowel resection or short bowel syndrome
- Has exclusionary laboratory or biochemical results at Screening
Participate in this trial
Are you interested in enrolling in this study? Learn more here.
I'm Interested In ParticipatingFor Referring Providers
Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.