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
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 PLN-74809 or matching placebo Part 3 - minimum 24-week, up to 48-week treatment period evaluating 320 mg of PLN-74809 or matching placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
Number of Participants With Treatment Emergent Adverse Events
Nature and proportion of TEAEs between PLN-74809 and placebo groups. Treatment-emergent adverse events (TEAEs) are defined as AEs that emerged or worsened in severity after the first administration of study drug
Time frame: Up to 40 weeks
Number of Participants With Serious Treatment Emergent Adverse Events
Nature and proportion of Serious TEAEs between PLN-74809 and placebo groups. An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Time frame: Up to 40 weeks
Assessment of PLN-74809 Total Plasma Concentrations at Week 12
Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hour Post Dose
Time frame: Up to 12 weeks
Assessment of PLN-74809 Total Plasma Concentrations at Week 24
Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hour Post Dose
Time frame: Up to 24 weeks
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California Liver Research Institute
Pasadena, California, United States
Stanford University School of Medicine
Redwood City, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
California Pacific Medical Center Research Institute
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Florida Research Institute
Lakewood Rch, Florida, United States
Schiff Center of Liver Diseases/University of Miami
Miami, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
...and 50 more locations