Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Escient Pharmaceuticals, Inc

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 sclerosis 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