At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 125 enrolled
Drug / intervention
Tolebrutinibdrug
Likely dose
Not stated in 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.
Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis
In Brief
A Phase 2 clinical trial evaluating Tolebrutinib for Relapsing Multiple Sclerosis. Completed, enrolled 125 participants across 37 sites in 9 countries.
Detailed Summary
Primary Objective: To determine the long-term safety and tolerability of SAR442168 in RMS participants Secondary Objective: To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesCanada, Czechia, Estonia, France, Netherlands, Russia, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartSep 2019
Primary CompletionNov 2024
TodayJul 2026
First PostedJun 24, 2019
Enrollment StartSep 23, 2019
Primary CompletionNov 26, 2024
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 7.0 years ago
Interventions
Tolebrutinibdrug
Pharmaceutical form: Film coated tablet Route of administration: Oral