drugset / Trial / NCT06372145
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]). SUBSTUDY: ToleDYNAMIC substudy
Timeline
- Start
- 2024-04-16
- Primary completion
- 2029-04-30
- Completion
- 2029-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolebrutinib | Small molecule | 60 mg | Oral |
| Comparator | Teriflunomide | Small molecule | 14 mg | Oral |