Phase 2
N=121
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis
Bottom Line
View on ClinicalTrials.gov: NCT04480840 ↗Enrolled (actual)
121
Serious AEs
3.3%
Results posted
Jan 2026
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events — 21; 10; 16; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PLN-74809 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pliant Therapeutics, Inc.
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events |
21; 10; 16; 15; 23 | — |
| PRIMARY Number of Participants With Serious Treatment Emergent Adverse Events |
1; 1; 1; 0; 1 | — |
| SECONDARY Assessment of PLN-74809 Total Plasma Concentrations at Week 12 |
0.00; 638.71; 843.06; 2035.95; 3667.50 | — |
| SECONDARY Assessment of PLN-74809 Total Plasma Concentrations at Week 24 |
0.00; 3583.64 | — |
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 and suspected liver fibrosis
Eligibility Criteria
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 10 times the upper limit of normal.
Data sourced from ClinicalTrials.gov (NCT04480840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.