Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
Status:
Recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
To determine the efficacy of SAR442168 compared to placebo in delaying disability progression
in primary progressive multiple sclerosis (PPMS)
Secondary Objectives:
To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic
resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of
life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics
(PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate
pharmacodynamics of SAR442168