At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
In Brief
A Phase 3 clinical trial evaluating Tolebrutinib and Placebo to match Tolebrutinib for Non-relapsing Secondary Progressive Multiple Sclerosis. Completed, enrolled 1,131 participants across 306 sites in 31 countries.
Detailed Summary
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS Secondary Objective: 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 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
Study Details
Timeline
Interventions
Pharmaceutical form: Film-coated tablet Route of administration: Oral
Pharmaceutical form: Film-coated tablet Route of administration: Oral