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)
Brief Title
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pruritus
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Pruritus
Itch
Primary Biliary Cholangitis
Primary Sclerosing Cholangitis
PACIFIC
EP547
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
18 Years
NCT Id
NCT05525520
Org Class
Industry
Org Full Name
Escient Pharmaceuticals, Inc
Org Study Id
EP-547-201
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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)
Outcome Measure
Change in Worst Itch Numeric Rating Scale (WI-NRS)
Outcome Time Frame
Measured from Baseline to Week 6
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
Measured from Baseline to Week 6
Outcome Measure
Change in 5-D Itch Scale
Outcome Description
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
Outcome Time Frame
Measured at Week 6
Outcome Measure
Proportion of subjects with improvement in pruritus as defined by PGI-C
Outcome Description
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
Outcome Time Frame
Measured from Baseline to Week 6
Outcome Measure
Proportion of subjects with improvement in pruritus severity from baseline as defined by PGI-S
Outcome Description
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)
Outcome Time Frame
Measured from Baseline to Week 6
Outcome Measure
Proportion of subjects with a reduction in WI-NRS ≥2 from baseline
Outcome Description
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)
Outcome Time Frame
Measured from Baseline to Week 6
Outcome Measure
Proportion of subjects with a reduction in WI-NRS ≥3 from baseline
Outcome Description
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)
Outcome Time Frame
Measured from Baseline to Week 6
Outcome Measure
Proportion of subjects with a reduction in WI-NRS ≥4 from baseline
Outcome Description
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)
Outcome Time Frame
Measured from Baseline to Week 6
Outcome Measure
Proportion of subjects with WI-NRS <4
Outcome Description
Safety and tolerability of EP547 measured through reporting of adverse events
Outcome Time Frame
Measured from Day 1 to End of Study or Early Termination (up to Week 6)
Outcome Measure
The incidence of adverse events
Outcome Description
To evaluate the pharmacokinetics of EP547
Outcome Time Frame
Measured from Day 1 to Week 6
Outcome Measure
Maximum Plasma Concentration [Cmax]
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Brett Fortune
Investigator Email
bfortune@montefiore.org