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

COMPLETEDPHASE2

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

A Randomized, Double-blind, Dose-ranging, Placebo-controlled, Phase 2a Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Primary Sclerosing Cholangitis (PSC) and Suspected Liver Fibrosis (INTEGRIS-PSC)

NCT04480840•Pliant Therapeutics, Inc.

View on ClinicalTrials.gov

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

Detailed Description

Three-part study: Part 1 - 12-week treatment period evaluating 40 mg of PLN-74809 or matching placebo \[Complete\] Part 2 - 12-week treatment period evaluating two dose groups, 80 mg and 160 mg of PLN-74809 or matching placebo Part 3 - minimum 24-week, up to 48-week treatment period evaluating 320 mg of PLN-74809 or matching placebo

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 within normal limits or \> 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 with no evidence of large duct involvement (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.

Locations (60)

California Liver Research Institute

Pasadena, California, United States

Stanford University School of Medicine

Redwood City, California, United States

University of California, Davis Medical Center

Sacramento, California, United States

California Pacific Medical Center Research Institute

San Francisco, California, United States

University of California San Francisco

San Francisco, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

Florida Research Institute

Lakewood Rch, Florida, United States

Schiff Center of Liver Diseases/University of Miami

Miami, Florida, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Key Dates

Start Date

July 27, 2020

Primary Completion Date

February 26, 2024

Completion Date

March 18, 2024

Last Updated

January 23, 2026

Enrollment

121

ACTUAL participants

Conditions

Primary Sclerosing Cholangitis

Interventions

PLN-74809

DRUG

Placebo

DRUG

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

NCT04753996

Primary Sclerosing CholangitisPSC+1 more

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RECRUITING

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

NCT05750498

Autoimmune HepatitisPrimary Sclerosing Cholangitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

Liver Cirrhosis Network Cohort Study

S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)

Genomics of Primary Sclerosing Cholangitis (PSC)