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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

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

More Details

Status
Completed
Sponsor
Escient Pharmaceuticals, Inc

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.