Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
- Registration Number
- NCT05525520
- Lead Sponsor
- Escient Pharmaceuticals, Inc
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EP547 100 mg EP547 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in Worst Itch Numeric Rating Scale (WI-NRS) Measured from Baseline to Week 6 Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
- Secondary Outcome Measures
Name Time Method Proportion of subjects with improvement in pruritus severity from baseline as defined by PGI-S Measured from Baseline to Week 6 Pruritus will be measured using the PGI-S scale to indicate severity of itch in the past 7 days using a 4-point scale from none to severe
Change in 5-D Itch Scale Measured from Baseline to Week 6 The 5-D Itch Scale will be used to measure change in pruritus covering five dimensions: degree, duration, direction, disability, and distribution. The total 5-D Itch Scale score ranges from 5 to 25, with higher scores indicating worse quality of life
Proportion of subjects with a reduction in WI-NRS ≥3 from baseline Measured from Baseline to Week 6 Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
The incidence of adverse events Measured from Day 1 to End of Study or Early Termination (up to Week 6) Safety and tolerability of EP547 measured through reporting of adverse events
Proportion of subjects with improvement in pruritus as defined by PGI-C Measured at Week 6 Change in pruritus will be measured using the PGI-C scale to indicate overall change in pruritus in the past 7 days compared to before treatment using a 7-point scale from much improved to much worse
Proportion of subjects with a reduction in WI-NRS ≥4 from baseline Measured from Baseline to Week 6 Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
Proportion of subjects with a reduction in WI-NRS ≥2 from baseline Measured from Baseline to Week 6 Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
Proportion of subjects with WI-NRS <4 Measured from Baseline to Week 6 Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
Maximum Plasma Concentration [Cmax] Measured from Day 1 to Week 6 To evaluate the pharmacokinetics of EP547
Trial Locations
- Locations (52)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
UPMC Center for Liver Disease
🇺🇸Pittsburgh, Pennsylvania, United States
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Liver Associates of Texas, PA
🇺🇸Houston, Texas, United States
Toronto Centre for Liver Disease Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
University of Miami - Schiff Center for Liver Diseases
🇺🇸Miami, Florida, United States
UZ Antwerpen
🇧🇪Antwerpen, Belgium
Rambam Medical Center- Keriat Eliezer Family Health Center
🇮🇱Haifa, Israel
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
UZ Leuven
🇧🇪Leuven, Belgium
Carmel Medical Center
🇮🇱Haifa, Israel
Hadassah Medical Center (Ein-Karem)
🇮🇱Jerusalem, Israel
(G.I.R.I.) GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
UZ Gent
🇧🇪Gent, Belgium
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
University of Alabama Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
Dignity Health Center for Clinical Research at St. Joseph Hospital
🇺🇸Phoenix, Arizona, United States
Gastro Health Research
🇺🇸Cincinnati, Ohio, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Hospital Rangueil
🇫🇷Toulouse, France
APHP Avicenne
🇫🇷Bobigny, France
Southern California Research Center
🇺🇸Coronado, California, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
California Liver Research Institute
🇺🇸Pasadena, California, United States
Science 37
🇺🇸Culver City, California, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
NYU Grossman School of Medicine Gastroenterology and Hepatology
🇺🇸New York, New York, United States
Digestive & Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Gastro Health & Nutrition
🇺🇸Katy, Texas, United States
Bon Secours Liver Institute of Virginia
🇺🇸Richmond, Virginia, United States
CHU de Lille
🇫🇷Lille, France
Centre hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montreal, Quebeck, Canada
CHU Grenoble- Alpes- Site Nord
🇫🇷Grenoble, France
Saint Antoine Hospital
🇫🇷Paris, France
Paul Brousse Hospital
🇫🇷Villejuif, France
Academic Medical Center- University of Amsterdam
🇳🇱Amsterdam, Netherlands
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain
Hospital General Universitario Alicante
🇪🇸Alicante, Spain
Hospital de Montecelo
🇪🇸Pontevedra, Spain
Campus Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, United Kingdom
Institute of Cellular Medicine, Newcastle University
🇬🇧Newcastle, United Kingdom
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
La Fe University and Polytechnic Hospital
🇪🇸Valencia, Spain
University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit
🇬🇧Nottingham, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
🇬🇧Norwich, United Kingdom
University Hospitals Plymouth NHS Trust - Derriford Hospital
🇬🇧Plymouth, United Kingdom
Montefiore Medical Center
🇺🇸Bronx, New York, United States