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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Pruritus

Intervention / Treatment
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* Drug: EP547
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EP547 100 mg<br> | Drug: EP547<br>* Once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| Maximum Plasma Concentration [Cmax] | To evaluate the pharmacokinetics of EP547 | Measured from Day 1 to Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pruritus, Itch, Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, PACIFIC, EP547