Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis
Completed
Sanofi
Phase 2
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.
Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
Active, not recruiting
Sanofi
Phase 2
Primary Objective:
To determine the long-term safety and tolerability of SAR442168 in RMS participants
Secondary Objective:
To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging
methods
Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects
Completed
Sanofi
Phase 1
Primary Objective:
To determine the excretion balance and systemic exposure of radioactivity after oral
administration of [14C]-SAR442168.
To determine the pharmacokinetics of SAR442168 and its contribution to the overall exposure
of radioactivity.
To collect samples in order to determine the metabolic pathways of SAR442168 and identify the
chemical structures and main excretion route of the main metabolites (samples will be
analyzed according to metabolic analysis plan and results will be documented in a separate
report).
Secondary Objective:
To assess the clinical and biological tolerability of an oral solution of SAR442168.
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