CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 877 enrolled
Drug / intervention
Ponesimoddrug
Likely dose
Ponesimod 20 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.

Search/NCT03232073
NCT03232073Phase 3Completed
CompareCT.gov

Multicenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis

Actelion·interventional·Posted Jul 27, 2017·Updated Jun 22, 2025

In Brief

A Phase 3 clinical trial evaluating Ponesimod for Multiple Sclerosis. Completed, enrolled 877 participants across 148 sites in 28 countries.

Detailed Summary

The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesBelarus, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czechia, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Poland, Portugal, Romania, Russia, Serbia, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 27, 2017
Enrollment StartJul 5, 2017
Primary CompletionJan 16, 2024
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 8.9 years ago

Interventions

Ponesimoddrug

Ponesimod; Film-coated tablet; Oral use. From Day 1 to Day 14, ponesimod is gradually up-titrated until a maintenance dose of 20 mg is reached from Day 15