NCT04480840

Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Pliant Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

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 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

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
DRUG	PLN-74809	PLN-74809
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-07-27
• Primary completion: 2024-02-26
• Completion: 2024-03-18
• First posted: 2020-07-21
• Last updated: 2026-01-23
• Results posted: 2026-01-23

Locations

60 sites across 9 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study