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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pruritus

In brief

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)

Key facts

Study ID

NCT05525520

Run by

Escient Pharmaceuticals, Inc

People needed

62

Starts

2022-10-06

Expected to finish

2024-09-05

Last updated by the study team

2025-07-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dignity Health Center for Clinical Research at St. Joseph Hospital — Phoenix, Arizona, United States
• Southern California Research Center — Coronado, California, United States
• Science 37 — Culver City, California, United States
• California Liver Research Institute — Pasadena, California, United States
• University of Miami - Schiff Center for Liver Diseases — Miami, Florida, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• NYU Grossman School of Medicine Gastroenterology and Hepatology — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Gastro Health Research — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• UPMC Center for Liver Disease — Pittsburgh, Pennsylvania, United States
• The Liver Institute at Methodist Dallas Medical Center — Dallas, Texas, United States
• Liver Associates of Texas, PA — Houston, Texas, United States
• Gastro Health & Nutrition — Katy, Texas, United States
• Digestive & Liver Disease Specialists — Norfolk, Virginia, United States
• Bon Secours Liver Institute of Virginia — Richmond, Virginia, United States
• UZ Antwerpen — Antwerp, Belgium
• UZ Gent — Ghent, Belgium
• UZ Leuven — Leuven, Belgium
• University of Alberta — Edmonton, Alberta, Canada
• University of Alabama Birmingham Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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