NCT05014672

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

TRANSFORM: A 24-week, Randomized, Placebo-controlled, Double-blind, Phase 2b Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Calliditas Therapeutics Suisse SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Primary Biliary Cholangitis
• Liver Stiffness

Interventions

Type	Name	Description
DRUG	Setanaxib	Oral tablets, 400mg per tablet
DRUG	Placebo	Oral tablets

Timeline

• Start date: 2022-02-14
• Primary completion: 2024-05-31
• Completion: 2024-07-02
• First posted: 2021-08-20
• Last updated: 2025-04-24
• Results posted: 2025-04-24

Locations

128 sites across 18 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Italy, New Zealand, Poland, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study