Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

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

Timeline

Start

2020-08-13

Primary completion

2025-11-14

Completion

2025-11-14

Outcome

Missed primary endpoint

release “Results from the PERSEUS phase 3 study (clinical study identifier: NCT04458051 ) showed that tolebrutinib did not meet its primary endpoint” sanofi.com ↗

Drugs

Indications