Trial results for the Phase 2 study (NCT03996291) investigating Tolebrutinib in participants with Relapsing Multiple Sclerosis were posted on ClinicalTrials.gov on 2025-10-23. The study's primary objective was to determine long-term safety and tolerability, with data indicating that up to 29 participants experienced treatment-emergent adverse events (TEAEs) in one dose group.
Background
Tolebrutinib was investigated in a study focused on participants with Relapsing Multiple Sclerosis (RMS).
Trial design
The study (NCT03996291), titled "Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis," was a Phase 2 trial that enrolled 125 participants. The study investigated tolebrutinib in individuals diagnosed with Relapsing Multiple Sclerosis. The primary objective was to determine the long-term safety and tolerability of tolebrutinib in RMS participants, with a secondary objective to evaluate efficacy on disease activity.
Key results
The trial results focused on the number of participants experiencing treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) across different dose groups:
- For TEAEs in Part A: 17 participants in the Tolebrutinib 5 mg group, 17 participants in the Tolebrutinib 15 mg group, 24 participants in the Tolebrutinib 30 mg group, and 20 participants in the Tolebrutinib 60 mg group reported events.
- For TEAEs in Part B: 26 participants in the Tolebrutinib 5/60 mg group, 29 participants in the Tolebrutinib 15/60 mg group, 27 participants in the Tolebrutinib 30/60 mg group, and 27 participants in the Tolebrutinib 60/60 mg group reported events.
- For TESAEs in Part A: 0 participants in the Tolebrutinib 5 mg group, 2 participants in the Tolebrutinib 15 mg group, 1 participant in the Tolebrutinib 30 mg group, and 2 participants in the Tolebrutinib 60 mg group reported events.
What this means
The posted results provide specific data on the long-term safety and tolerability of tolebrutinib in participants with Relapsing Multiple Sclerosis. The detailed counts of treatment-emergent adverse events and serious adverse events across various dose groups offer insights into the safety profile of the drug in this patient population. These findings are crucial for the ongoing assessment of tolebrutinib as a potential treatment option for RMS.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03996291, titled "Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis," were posted on 2025-10-23 on clinicaltrials.gov.