Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis

Summary

Primary Objective: To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions. Secondary Objectives: * To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures. * To evaluate the safety and tolerability of SAR442168.

Timeline

Start

2019-03-29

Primary completion

2020-01-02

Completion

2020-01-02

Publications

• Reich DS, Arnold DL, Vermersch P, Bar-Or A, Fox RJ, Matta A, Turner T, Wallstrom E, Zhang X, Mares M, Khabirov FA, Traboulsee A; Tolebrutinib Phase 2b Study Group. Safety and efficacy of tolebrutinib, an oral brain-penetrant BTK inhibitor, in relapsing multiple sclerosis: a phase 2b, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2021 Sep;20(9):729-738. doi: 10.1016/S1474-4422(21)00237-4.

Drugs

Indications