Trial Search Results
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
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
Stanford is currently accepting patients for this trial.
Pliant Therapeutics, Inc.
- Drug: PLN-74809
- Drug: Placebo
- 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.
- 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
- Small duct PSC (evidence of PSC on historical liver histology, with normal bile ducts
- 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.
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study