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.

Lead Sponsor:

Pliant Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: PLN-74809
  • Drug: Placebo

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Smart
650-721-8517
Recruiting