NCT05525520CompletedPhase 2
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 30 Aug 2022
- Start date
- 6 Oct 2022
- Primary completion date
- 17 Jul 2024
- Lead sponsor
- Escient Pharmaceuticals, Inc
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT05525520
- EudraCT number
- 2021-002526-25
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 62
- From 6 Oct 2022 to the primary completion date, 17 Jul 2024
- 52 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or planned liver transplantation
Other illness
- Alternative causes of liver disease
- History of significant small bowel resection or short bowel syndrome
Lab values
- Has exclusionary laboratory or biochemical results at Screening
Other
- Pruritus associated with an etiology other than PBC or PSC
- Evidence of compensated or decompensated cirrhosis
- Presence of documented secondary sclerosing cholangitis
- Current evidence of clinically significant high-grade strictures or presence of biliary stent
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (52)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Antwerpen Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Toronto Centre for Liver Disease Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| (G.I.R.I.) GI Research Institute Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Hospital General Universitario Alicante Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Clinic Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital de Montecelo Coordinator of this site? Confirm its status | Pontevedra | Spain | Unknown status |
| Campus Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| La Fe University and Polytechnic Hospital Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Aphp Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Unknown status |
| CHU Grenoble Alpes - Site Nord Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| CHU de Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Saint-Antoine Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hospital Rangueil Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Paul Brousse Hospital Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| University Hospitals Birmingham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Glasgow Royal Infirmary Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| King's College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Institute of Cellular Medicine, Newcastle University Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Norfolk and Norwich University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
| University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| University Hospitals Plymouth NHS Trust, Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Rambam Medical Center- Keriat Eliezer Family Health Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center - Ein Karem Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Academic Medical Center, University of Amsterdam Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| University of Alabama Birmingham Hospital Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Gastro Health Research Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Southern California Research Center Coordinator of this site? Confirm its status | Coronado | United States | Unknown status |
| Science 37 Coordinator of this site? Confirm its status | Culver City | United States | Unknown status |
| The Liver Institute at Methodist Dallas Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Liver Associates of Texas, PA Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Iowa Hospitals & Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Gastro Health & Nutrition Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| University of Miami - Schiff Center for Liver Diseases Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Tulane University Health Sciences Center Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Ochsner Medical Center Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| NYU Grossman School of Medicine Gastroenterology and Hepatology Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Digestive & Liver Disease Specialists Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| California Liver Research Institute Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Dignity Health Center for Clinical Research at St. Joseph Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| UPMC Center for Liver Disease Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Bon Secours Liver Institute of Virginia Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.