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

Escient Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Pruritus

Treatments: Drug: Placebo; Drug: EP547

Study type: Interventional

Funder types: Industry

Identifiers

NCT05525520

EP-547-201

Details and patient eligibility

About

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)

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

EP547 100 mg

Experimental group

Treatment:

Drug: EP547

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo