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

NCT05525520 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: EP-547-2012021-002526-25
• Study Type: interventional
• Target: 62
• Locations: 8 countries
• Sites: 52

Brief 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)

Conditions

Pruritus

Keywords

Pruritus; Itch; Primary Biliary Cholangitis; Primary Sclerosing Cholangitis; PACIFIC; EP547

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Worst Itch Numeric Rating Scale (WI-NRS) Score up to Week 6

  Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\<4), moderate (≥4 to \<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.

  Baseline; up to Week 6

Secondary Outcomes (17)

• Change From Baseline in the 5-D Itch Scale Total Score at Week 6

  Baseline; Week 6

• Percentage of Participants With Improvement in Pruritus as Defined by Patient Global Impression of Change (PGI-C) at Week 6

  Baseline; Week 6

• Percentage of Participants With Improvement in Pruritus Severity From Baseline as Defined by Change in Patient Global Impress of Severity (PGI-S) at Week 6

  Baseline; Week 6

• Percentage of Participants With a Reduction in WI-NRS Score ≥2 From Baseline at Week 6

  Baseline; Week 6

• Percentage of Participants With a Reduction in WI-NRS Score ≥3 From Baseline at Week 6

  Baseline; Week 6

Study Arms (2)

EP547 100 mg

EXPERIMENTAL

Drug: EP547

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EP547 DRUG

Once daily

EP547 100 mg

Placebo DRUG

Once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Escient Pharmaceuticals, Inc: lead

Study Sites (52)

University of Alabama Birmingham Hospital

Birmingham, Alabama, 35294, United States

Location

Dignity Health Center for Clinical Research at St. Joseph Hospital

Phoenix, Arizona, 85013, United States

Location

Southern California Research Center

Coronado, California, 92118, United States

Location

Science 37

Culver City, California, 90230, United States

Location

California Liver Research Institute

Pasadena, California, 91105, United States

Location

University of Miami - Schiff Center for Liver Diseases

Miami, Florida, 33136, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

NYU Grossman School of Medicine Gastroenterology and Hepatology

New York, New York, 10016, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Gastro Health Research

Cincinnati, Ohio, 45249, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

UPMC Center for Liver Disease

Pittsburgh, Pennsylvania, 15213, United States

Location

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Liver Associates of Texas, PA

Houston, Texas, 77030, United States

Location

Gastro Health & Nutrition

Katy, Texas, 77494, United States

Location

Digestive & Liver Disease Specialists

Norfolk, Virginia, 23502, United States

Location

Bon Secours Liver Institute of Virginia

Richmond, Virginia, 23226, United States

Location

UZ Antwerpen

Antwerp, Belgium

Location

UZ Gent

Ghent, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

University of Alberta

Edmonton, Alberta, T6G 2X8, Canada

Location

(G.I.R.I.) GI Research Institute

Vancouver, British Columbia, Canada

Location

Toronto Centre for Liver Disease Toronto General Hospital

Toronto, Ontario, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebeck, H2X 0A9, Canada

Location

APHP Avicenne

Bobigny, France

Location

CHU Grenoble- Alpes- Site Nord

Grenoble, France

Location

CHU de Lille

Lille, France

Location

Saint Antoine Hospital

Paris, France

Location

Hospital Rangueil

Toulouse, France

Location

Paul Brousse Hospital

Villejuif, France

Location

Carmel Medical Center

Haifa, Israel

Location

Rambam Medical Center- Keriat Eliezer Family Health Center

Haifa, Israel

Location

Hadassah Medical Center (Ein-Karem)

Jerusalem, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, Israel

Location

Academic Medical Center- University of Amsterdam

Amsterdam, Netherlands

Location

Hospital General Universitario Alicante

Alicante, Spain

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Hospital de Montecelo

Pontevedra, Spain

Location

Campus Hospital Universitario Virgen del Rocio

Seville, Spain

Location

La Fe University and Polytechnic Hospital

Valencia, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, United Kingdom

Location

Institute of Cellular Medicine, Newcastle University

Newcastle, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, United Kingdom

Location

University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit

Nottingham, United Kingdom

Location

University Hospitals Plymouth NHS Trust - Derriford Hospital

Plymouth, United Kingdom

Location

MeSH Terms

Conditions

Pruritus; Liver Cirrhosis, Biliary; Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Cholangitis

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: October 6, 2022
• Primary Completion: July 17, 2024
• Study Completion: September 5, 2024
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); BE (3); NL (1); FR (6); US (21); IL (4); GB (7); ES (6)