Clinical trial NCT05525520: Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pruritus
Keywords: Pruritus
Itch
Primary Biliary Cholangitis
Primary Sclerosing Cholangitis
PACIFIC
EP547
Lead sponsor: Escient Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2022-09-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Change in Worst Itch Numeric Rating Scale (WI-NRS)
timeFrame: Measured from Baseline to Week 6
Secondary outcomes:
measure: Change in 5-D Itch Scale
timeFrame: Measured from Baseline to Week 6
measure: Proportion of subjects with improvement in pruritus as defined by PGI-C
timeFrame: Measured at Week 6
measure: Proportion of subjects with improvement in pruritus severity from baseline as defined by PGI-S
timeFrame: Measured from Baseline to Week 6
measure: Proportion of subjects with a reduction in WI-NRS ≥2 from baseline
timeFrame: Measured from Baseline to Week 6
measure: Proportion of subjects with a reduction in WI-NRS ≥3 from baseline
timeFrame: Measured from Baseline to Week 6
measure: Proportion of subjects with a reduction in WI-NRS ≥4 from baseline
timeFrame: Measured from Baseline to Week 6
measure: Proportion of subjects with WI-NRS <4
timeFrame: Measured from Baseline to Week 6
measure: The incidence of adverse events
timeFrame: Measured from Day 1 to End of Study or Early Termination (up to Week 6)
measure: Maximum Plasma Concentration [Cmax]
timeFrame: Measured from Day 1 to Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham Hospital
state: Alabama
city: Phoenix
country: United States
facility: Dignity Health Center for Clinical Research at St. Joseph Hospital
state: Arizona
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Culver City
country: United States
facility: Science 37
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Miami
country: United States
facility: University of Miami - Schiff Center for Liver Diseases
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU Grossman School of Medicine Gastroenterology and Hepatology
state: New York
city: Cincinnati
country: United States
facility: Gastro Health Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Center for Liver Disease
state: Pennsylvania
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas, PA
state: Texas
city: Katy
country: United States
facility: Gastro Health & Nutrition
state: Texas
city: Norfolk
country: United States
facility: Digestive & Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Liver Institute of Virginia
state: Virginia
city: Antwerpen
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: (G.I.R.I.) GI Research Institute
state: British Columbia
city: Toronto
country: Canada
facility: Toronto Centre for Liver Disease Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebeck
city: Bobigny
country: France
facility: APHP Avicenne
city: Grenoble
country: France
facility: CHU Grenoble- Alpes- Site Nord
city: Lille
country: France
facility: CHU de Lille
city: Paris
country: France
facility: Saint Antoine Hospital
city: Toulouse
country: France
facility: Hospital Rangueil
city: Villejuif
country: France
facility: Paul Brousse Hospital
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center- Keriat Eliezer Family Health Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center (Ein-Karem)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Amsterdam
country: Netherlands
facility: Academic Medical Center- University of Amsterdam
city: Alicante
country: Spain
facility: Hospital General Universitario Alicante
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Pontevedra
country: Spain
facility: Hospital de Montecelo
city: Sevilla
country: Spain
facility: Campus Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: La Fe University and Polytechnic Hospital
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: Institute of Cellular Medicine, Newcastle University
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust - Derriford Hospital
Study officials:
References: