©2024 Stanford Medicine
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
Not Recruiting
Trial ID: NCT04480840
Purpose
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
Official Title
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)
Stanford Investigator(s)
Aparna Goel
Clinical Associate Professor, Medicine - Gastroenterology & Hepatology
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®) 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.
Intervention(s):
drug: PLN-74809
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer Smart
650-721-8517