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

Last updated: October 10, 2024
Sponsor: Escient Pharmaceuticals, Inc
Overall Status: Completed

Phase

2

Condition

Hives (Urticaria)

Liver Disorders

Liver Disease

Treatment

EP547

Placebo

Clinical Study ID

NCT05525520
EP-547-201
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

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 additionalrelevant criteria

Exclusion

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 ofbiliary stent

  • History of significant small bowel resection or short bowel syndrome

  • Has exclusionary laboratory or biochemical results at Screening

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: EP547
Phase: 2
Study Start date:
October 06, 2022
Estimated Completion Date:
September 05, 2024

Connect with a study center

  • UZ Antwerpen

    Antwerpen,
    Belgium

    Site Not Available

  • UZ Gent

    Gent,
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven,
    Belgium

    Site Not Available

  • University of Alberta

    Edmonton, Alberta T6G 2X8
    Canada

    Site Not Available

  • (G.I.R.I.) GI Research Institute

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Toronto Centre for Liver Disease Toronto General Hospital

    Toronto, Ontario
    Canada

    Site Not Available

  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebeck H2X 0A9
    Canada

    Site Not Available

  • APHP Avicenne

    Bobigny,
    France

    Site Not Available

  • CHU Grenoble- Alpes- Site Nord

    Grenoble,
    France

    Site Not Available

  • CHU de Lille

    Lille,
    France

    Site Not Available

  • Saint Antoine Hospital

    Paris,
    France

    Site Not Available

  • Hospital Rangueil

    Toulouse,
    France

    Site Not Available

  • Paul Brousse Hospital

    Villejuif,
    France

    Site Not Available

  • Carmel Medical Center

    Haifa,
    Israel

    Site Not Available

  • Rambam Medical Center- Keriat Eliezer Family Health Center

    Haifa,
    Israel

    Site Not Available

  • Hadassah Medical Center (Ein-Karem)

    Jerusalem,
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Ramat Gan,
    Israel

    Site Not Available

  • Academic Medical Center- University of Amsterdam

    Amsterdam,
    Netherlands

    Site Not Available

  • Hospital General Universitario Alicante

    Alicante,
    Spain

    Site Not Available

  • Hospital Clinic Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Hospital de Montecelo

    Pontevedra,
    Spain

    Site Not Available

  • Campus Hospital Universitario Virgen del Rocio

    Sevilla,
    Spain

    Site Not Available

  • La Fe University and Polytechnic Hospital

    Valencia,
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza,
    Spain

    Site Not Available

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham,
    United Kingdom

    Site Not Available

  • Glasgow Royal Infirmary

    Glasgow,
    United Kingdom

    Site Not Available

  • King's College Hospital NHS Foundation Trust

    London,
    United Kingdom

    Site Not Available

  • Institute of Cellular Medicine, Newcastle University

    Newcastle,
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich,
    United Kingdom

    Site Not Available

  • University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit

    Nottingham,
    United Kingdom

    Site Not Available

  • University Hospitals Plymouth NHS Trust - Derriford Hospital

    Plymouth,
    United Kingdom

    Site Not Available

  • University of Alabama Birmingham Hospital

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Dignity Health Center for Clinical Research at St. Joseph Hospital

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Southern California Research Center

    Coronado, California 92118
    United States

    Site Not Available

  • Science 37

    Culver City, California 90230
    United States

    Site Not Available

  • California Liver Research Institute

    Pasadena, California 91105
    United States

    Site Not Available

  • University of Miami - Schiff Center for Liver Diseases

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Tulane University Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Southern Therapy and Advanced Research

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • NYU Grossman School of Medicine Gastroenterology and Hepatology

    New York, New York 10016
    United States

    Site Not Available

  • Gastro Health Research

    Cincinnati, Ohio 45249
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • UPMC Center for Liver Disease

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas 75203
    United States

    Site Not Available

  • Liver Associates of Texas, PA

    Houston, Texas 77030
    United States

    Site Not Available

  • Gastro Health & Nutrition

    Katy, Texas 77494
    United States

    Site Not Available

  • Digestive & Liver Disease Specialists

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Bon Secours Liver Institute of Virginia

    Richmond, Virginia 23226
    United States

    Site Not Available

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