Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis

Phase 2 Completed 130 enrolled Sanofi

RandomizedCrossoverDouble-blindTreatment

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

Outcome

Met primary endpoint

registry SAR442168 60 mg; p = 0.0178; Relative reduction in lesions 85.02 (95% CI 28.02 to 96.88) NCT03889639 ↗

release “Sanofi brain-penetrant BTK inhibitor meets primary endpoint of Phase 2 trial in relapsing multiple sclerosis” sanofi.com ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	Tolebrutinib	Small molecule	5 mg	Oral
Subject	Tolebrutinib	Small molecule	15 mg	Oral
Subject	Tolebrutinib	Small molecule	30 mg	Oral
Subject	Tolebrutinib	Small molecule	60 mg	Oral