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

Pruritus Clinical Trial

— PACIFIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05525520
• Other study ID #: EP-547-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 6, 2022
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Escient Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Liver Cirrhosis, Biliary
• Pruritus

Intervention

Drug:
• EP547
Once daily
• Placebo
Once daily

Locations

Country	Name	City	State
Belgium	UZ Antwerpen	Antwerpen
Belgium	UZ Gent	Gent
Belgium	UZ Leuven	Leuven
Canada	University of Alberta	Edmonton	Alberta
Canada	Centre hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebeck
Canada	Toronto Centre for Liver Disease Toronto General Hospital	Toronto	Ontario
Canada	(G.I.R.I.) GI Research Institute	Vancouver	British Columbia
France	APHP Avicenne	Bobigny
France	CHU Grenoble- Alpes- Site Nord	Grenoble
France	CHU de Lille	Lille
France	Saint Antoine Hospital	Paris
France	Hospital Rangueil	Toulouse
France	Paul Brousse Hospital	Villejuif
Israel	Carmel Medical Center	Haifa
Israel	Rambam Medical Center- Keriat Eliezer Family Health Center	Haifa
Israel	Hadassah Medical Center (Ein-Karem)	Jerusalem
Israel	Chaim Sheba Medical Center	Ramat Gan
Netherlands	Academic Medical Center- University of Amsterdam	Amsterdam
Spain	Hospital General Universitario Alicante	Alicante
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital de Montecelo	Pontevedra
Spain	Campus Hospital Universitario Virgen del Rocio	Sevilla
Spain	La Fe University and Polytechnic Hospital	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	Institute of Cellular Medicine, Newcastle University	Newcastle
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich
United Kingdom	University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit	Nottingham
United Kingdom	University Hospitals Plymouth NHS Trust - Derriford Hospital	Plymouth
United States	University of Alabama Birmingham Hospital	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Gastro Health Research	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Southern California Research Center	Coronado	California
United States	Science 37	Culver City	California
United States	The Liver Institute at Methodist Dallas Medical Center	Dallas	Texas
United States	Liver Associates of Texas, PA	Houston	Texas
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Gastro Health & Nutrition	Katy	Texas
United States	University of Miami - Schiff Center for Liver Diseases	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	NYU Grossman School of Medicine Gastroenterology and Hepatology	New York	New York
United States	Digestive & Liver Disease Specialists	Norfolk	Virginia
United States	California Liver Research Institute	Pasadena	California
United States	Dignity Health Center for Clinical Research at St. Joseph Hospital	Phoenix	Arizona
United States	UPMC Center for Liver Disease	Pittsburgh	Pennsylvania
United States	Bon Secours Liver Institute of Virginia	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Escient Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Israel,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Worst Itch Numeric Rating Scale (WI-NRS)	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)	Measured from Baseline to Week 6
Secondary	Change in 5-D Itch Scale	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	Measured from Baseline to Week 6
Secondary	Proportion of subjects with improvement in pruritus as defined by PGI-C	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	Measured at Week 6
Secondary	Proportion of subjects with improvement in pruritus severity from baseline as defined by PGI-S	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	Measured from Baseline to Week 6
Secondary	Proportion of subjects with a reduction in WI-NRS =2 from baseline	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)	Measured from Baseline to Week 6
Secondary	Proportion of subjects with a reduction in WI-NRS =3 from baseline	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)	Measured from Baseline to Week 6
Secondary	Proportion of subjects with a reduction in WI-NRS =4 from baseline	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)	Measured from Baseline to Week 6
Secondary	Proportion of subjects with WI-NRS <4	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)	Measured from Baseline to Week 6
Secondary	The incidence of adverse events	Safety and tolerability of EP547 measured through reporting of adverse events	Measured from Day 1 to End of Study or Early Termination (up to Week 6)
Secondary	Maximum Plasma Concentration [Cmax]	To evaluate the pharmacokinetics of EP547	Measured from Day 1 to Week 6