A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness

Summary

The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).

Timeline

Start

2022-02-14

Primary completion

2024-05-31

Completion

2024-07-02

Outcome

Met primary endpoint

registry analysis (superiority test); Setanaxib 1200 mg/Day; p = 0.0206; Ratio of geometric LS mean vs placebo 0.86 (95% CI 0.746 to 0.994); NCT05014672 ↗

registry analysis (superiority test); Setanaxib 1600 mg/Day; p = 0.0057; Ratio of geometric LS mean vs placebo 0.81 (95% CI 0.703 to 0.939); NCT05014672 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Setanaxib	Small molecule	1200 mg	Oral
Subject	Setanaxib	Small molecule	1600 mg	Oral

Indications