A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
← catalyst calendarNCT06372145 · readout in 985 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
2,500estimated
Sites
352
Countries
Argentina, Australia, Austria +44
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-04-16 | actual | When the study began enrolling |
| Primary completion | 2029-04-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-04-30 | estimated | The whole study's end, after follow-up |
| First posted | 2024-04-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Relapsing Multiple Sclerosis
- Secondary Progressive Multiple Sclerosis
- Progressive Relapsing Multiple Sclerosis
Interventions
- Drug: Tolebrutinib — also filed as SAR442168
- Drug: Placebo
- Drug: Teriflunomide — also filed as Aubagio
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation
measured From baseline until the End of study approximately 4 years per participant
Number of Participants with Potentially clinically significant abnormalities (PCSAs)
measured From baseline until the End of study approximately 4 years per participant
Publications
- PMID 42546561 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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