NCT03996291

Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Detailed description

Approximately 62 months including the 8 weeks post-treatment visit

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Tolebrutinib	Pharmaceutical form: Film coated tablet Route of administration: Oral

Timeline

• Start date: 2019-09-23
• Primary completion: 2024-11-26
• Completion: 2024-11-26
• First posted: 2019-06-24
• Last updated: 2025-10-23
• Results posted: 2025-10-23

Locations

37 sites across 9 countries: United States, Canada, Czechia, Estonia, France, Netherlands, Russia, Spain, Ukraine

Regulatory

• FDA-regulated drug study