Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

  • STATUS
    Not Recruiting
  • End date
    Aug 25, 2024
  • participants needed
    990
  • sponsor
    Sanofi
Updated on 8 August 2022
disease or disorder
oligoclonal bands

Summary

Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS)

Secondary Objectives:

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 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168

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.

Details
Condition Primary Progressive Multiple Sclerosis
Treatment Placebo, SAR442168, Tolebrutinib
Clinical Study IdentifierNCT04458051
SponsorSanofi
Last Modified on8 August 2022

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