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)
University of Alabama Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
Dignity Health Center for Clinical Research at St. Joseph Hospital
🇺🇸Phoenix, Arizona, United States
Southern California Research Center
🇺🇸Coronado, California, United States
Science 37
🇺🇸Culver City, California, United States
California Liver Research Institute
🇺🇸Pasadena, California, United States
University of Miami - Schiff Center for Liver Diseases
🇺🇸Miami, Florida, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
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