At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 353 enrolled
Drug / intervention
Ponesimod 10 mg +2 moredrug
Likely dose
Ponesimod 10 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.
Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis
In Brief
A Phase 2 clinical trial evaluating Ponesimod 10 mg, Ponesimod 20 mg, and 1 other intervention for Multiple Sclerosis. Completed, enrolled 353 participants across 71 sites in 20 countries.
Detailed Summary
This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesAustria, Bulgaria, Canada, Czechia, Finland, France, Germany, Hungary, Israel, Netherlands, Poland, Romania, Russia, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartMay 2010
Primary CompletionSep 2023
TodayJul 2026
First PostedMar 25, 2010
Enrollment StartMay 12, 2010
Primary CompletionSep 6, 2023
TodayJul 2, 2026
Enrollment to primary: 13.3 yearsPosted 16.3 years ago
Interventions
Ponesimod 10 mgdrug
Ponesimod 10 mg oral use
Ponesimod 20 mgdrug
Ponesimod 20 mg oral use
Ponesimod 40 mgdrug
Ponesimod 40 mg oral use