Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    84
  • sponsor
    Pliant Therapeutics, Inc.
Updated on 9 June 2022
MRI
endoscopic retrograde cholangiopancreatography
fibrosis
ursodiol
magnetic resonance cholangiopancreatography

Summary

A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis

Description

Two-part study:

Part 1 - 12-week treatment period evaluating 40 mg of PLN-74809 or matching placebo Part 2 - 12-week treatment period evaluating two dose groups, 80 mg and 160 mg of PLN-74809 or matching placebo

Details
Condition Primary Sclerosing Cholangitis
Treatment Placebo, PLN-74809
Clinical Study IdentifierNCT04480840
SponsorPliant Therapeutics, Inc.
Last Modified on9 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Established clinical diagnosis of large duct PSC based on an abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), and/or percutaneous transhepatic cholangiopancreatography (PTC) in the context of cholestatic liver chemistry
Suspected liver fibrosis, as defined by liver stiffness measurement (LSM), assessed by ultrasound-based transient elastography (TE, FibroScan®) OR Enhanced Liver Fibrosis (ELF) Score OR Historical liver biopsy showing fibrosis without cirrhosis (by any scoring system) OR Magnetic resonance elastography (MRE)
Serum ALP concentration > 1 times the upper limit of normal (ULN)
Participants receiving treatment for IBD are allowed, if on a stable dose from screening and expected to remain stable for the duration of the study
Serum AST and ALT concentration ≤ 5 times the upper limit of normal
If receiving treatment with UDCA, therapy is at a dose of < 25 mg/kg/day, has been stable for at least 3 months before screening

Exclusion Criteria

Other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically
Known or suspected overlapping clinical and histologic diagnosis of autoimmune hepatitis
Small duct PSC (evidence of PSC on historical liver histology, with normal bile ducts on cholangiography)
Presence of liver cirrhosis as assessed by liver histology, ultrasound-based liver stiffness measurement, ELF score, MRE, and/or signs and symptoms of hepatic decompensation (including but not limited to, jaundice, ascites, variceal hemorrhage, and/or hepatic encephalopathy
Serum ALP concentration > 10 times the upper limit of normal
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