At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
Vidofludimus calciumdrug
Likely dose
Vidofludimus calcium 30 mgfrom 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.
Investigation of the Activity of Vidofludimus Calcium, a Novel, Orally Available, Small Molecule Inhibitor of Dihydroorotate Dehydrogenase, as a Treatment for Primary Sclerosing Cholangitis (PSC)
In Brief
A Phase 2 clinical trial evaluating Vidofludimus calcium for Primary Sclerosing Cholangitis. Completed, enrolled 18 participants across 3 sites.
Detailed Summary
To examine the safety, tolerability, and efficacy of daily dosing with vidofludimus calcium over a 6-month period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Sclerosing Cholangitis
CountriesUnited States
CollaboratorsArizona State University
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartJun 2019
Primary CompletionJun 2020
TodayJul 2026
First PostedOct 29, 2018
Enrollment StartJun 17, 2019
Primary CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.7 years ago
Interventions
Vidofludimus calciumdrug
During the 6-month treatment period, subjects will receive 30 mg VC orally once daily. This will be preceded by a lead-in dosing period where subjects will receive 15 mg VC once daily for 1 week.