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

Purpose

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)

Condition

  • Pruritus

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
EP547 100 mg
  • Drug: EP547
    Once daily
Placebo Comparator
Placebo
  • Drug: Placebo
    Once daily

Recruiting Locations

University of Alabama Birmingham Hospital
Birmingham, Alabama 35294
Contact:
Alesha Matthews
205-996-4744
aleshamatthews@uabmc.edu

More Details

Status
Recruiting
Sponsor
Escient Pharmaceuticals, Inc

Study Contact

Escient Clinical Trials
858-617-8220
clinicaltrials@escientpharma.com