ClinicalTrials.Veeva

Menu
The trial is taking place at:
S

Southern California Research Center | Coronado, CA

Veeva-enabled site

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

E

Escient Pharmaceuticals

Status and phase

Active, not recruiting
Phase 2

Conditions

Pruritus

Treatments

Drug: EP547
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05525520
EP-547-201

Details and patient eligibility

About

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)

Enrollment

58 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

58 participants in 2 patient groups, including a placebo group

EP547 100 mg
Experimental group
Treatment:
Drug: EP547
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

53

Loading...

Central trial contact

Escient Clinical Trials

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems