Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
- Study HIC#:2000029307
- Last Updated:01/01/0001
The main purpose of this study is to determine the safety and tolerability of PLN-74809 compared to a placebo, when taken daily for up to 12 weeks. The study also aims to determine how the body processes the study medication and assess any changes in the condition PSC.
If you have been diagnosed with primary sclerosing cholangitis (PSC), a rare, long-term liver disease affecting the bile ducts inside and outside the liver you could be eligible to participate in a research study by Pliant Therapeutics, investigating a medication named PLN-74809 for the treatment of PSC.
- Age18 years - 75 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Suzie Christopher
- Phone Number: 1-203-785-4138
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and 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
Eligibility Criteria
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®)
- Serum ALP concentration > 1.5 times the upper limit of normal (ULN)
- Participants receiving treatment for IBD are allowed, if on a stable dose for at least 3 months
- 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 historical liver histology, ultrasound-based liver stiffness measurement (FibroScan® value > 14.4 kPa), 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.
