Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
767actual
Sites
277
Countries
Argentina, Australia, Austria +39
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 | 2020-08-13 | actual | When the study began enrolling |
| Primary completion | 2025-11-14 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-14 | actual | The whole study's end, after follow-up |
| First posted | 2020-07-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Primary Progressive Multiple Sclerosis
Interventions
- Drug: Tolebrutinib — also filed as SAR442168
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OF6-month composite Confirmed Disability Progression (cCDP)
measured Up to approximately 60 months
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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