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Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) — HERCULES  

Secondary Progressive Multiple Sclerosis Clinical Trial

Official title:
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis

Clinical Trial 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

Clinical Trial Description

Study duration will vary per participant in this event driven trial with a treatment duration of approximately 24 to 48 months. Participants completing the treatment period will be proposed to enroll in a separate long term safety study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04411641
Study type Interventional
Source Sanofi
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 24, 2020
Completion date August 2024
View Details
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