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

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Sclerosing Cholangitis

In brief

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

Key facts

Study ID

NCT04480840

Run by

Pliant Therapeutics, Inc.

People needed

121

Starts

2020-07-27

Expected to finish

2024-03-18

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Indiana University Health University Hospital — Indianapolis, Indiana, United States
• Massachusetts General Hospital Gastroenterology Liver Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Novi, Michigan, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
• Vanderbilt Digestive Disease Center — Nashville, Tennessee, United States
• Baylor College of Medicine - Advanced Liver Therapies — Houston, Texas, United States
• Bon Secours Liver Institute of Hampton Roads — Newport News, Virginia, United States
• VCU Health Clinical Research Services Unit — Richmond, Virginia, United States
• Liver Institute Northwest — Seattle, Washington, United States
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Liverpool Hospital: Department of Gastroenterology and Hepatology — Liverpool, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• California Liver Research Institute — Pasadena, California, United States

Full record on ClinicalTrials.gov

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