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Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

NCT05525520•Escient Pharmaceuticals, Inc

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (52)

University of Alabama Birmingham Hospital

Birmingham, Alabama, United States

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

Key Dates

Start Date

October 6, 2022

Primary Completion Date

July 17, 2024

Completion Date

September 5, 2024

Last Updated

July 31, 2025

Enrollment

ACTUAL participants

Conditions

Pruritus

Interventions

EP547

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy

Effects of Acupuncture for Senile Pruritus

Meditation in Inflammatory Dermatosis

The Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in Patients With Atopic Dermatitis

Anrikefon vs Nalfurafine for Sleep Quality in Hemodialysis Patients With CKD-aP

Effect of Topically Applied Olive Oil on Pruritus in Hemodialysis Patients: Pretest-posttest Model With Control Group