Status:
COMPLETED
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
Lead Sponsor:
Pliant Therapeutics, Inc.
Conditions:
Primary Sclerosing Cholangitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Three-part study: Part 1 - 12-week treatment period evaluating 40 mg of PLN-74809 or matching placebo \[Complete\] Part 2 - 12-week treatment period evaluating two dose groups, 80 mg and 160 mg of PL...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2024
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT04480840
Start Date
July 27 2020
End Date
March 18 2024
Last Update
April 12 2024
Active Locations (60)
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1
California Liver Research Institute
Pasadena, California, United States, 91105
2
Stanford University School of Medicine
Redwood City, California, United States, 94063
3
University of California, Davis Medical Center
Sacramento, California, United States, 95817
4
California Pacific Medical Center Research Institute
San Francisco, California, United States, 94109