SAR442168 is being developed for the indication of treatment of patients with MS. This study is designed to collect evidence of efficacy and safety of the drug.
The goal of this Phase 3 clinical trial is to demonstrate the efficacy and safety of SAR442168 compared to placebo in participants with primary progressive multiple sclerosis (PPMS).
Globally approximately 990 participants will be randomly assigned to study intervention (2:1 randomization ratio of SAR442168 to placebo). This study is planned as an event-driven trial based on 6-month confirmed disease progression (CDP) therefore treatment duration ranging from approximately 24 to 48 months in participants with PPMS.
All participants with 6-month CDP are eligible for open-label active treatment as rescue (SAR442168). In Australia 2 sites will participate to recruit 4 participants.