At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 76 enrolled
Drug / intervention
Setanaxib +1 moredrug
Likely dose
Setanaxib 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Setanaxib and Placebo for Primary Biliary Cholangitis and Liver Stiffness. Completed, enrolled 76 participants across 128 sites in 18 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cholangitis, Liver Stiffness
CountriesAustralia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Italy, New Zealand, Poland, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartFeb 2022
Primary CompletionMay 2024
Study CompletionJul 2024
TodayJul 2026
First PostedAug 20, 2021
Enrollment StartFeb 14, 2022
Primary CompletionMay 31, 2024
Study CompletionJul 2, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.9 years ago
Interventions
Setanaxibdrug
Oral tablets, 400mg per tablet
Placebodrug
Oral tablets