Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

  • STATUS
    Not Recruiting
  • End date
    Aug 28, 2023
  • participants needed
    900
  • sponsor
    Sanofi
Updated on 8 August 2022
Investigator
For site information, send an email with site number to
Primary Contact
Investigational Site Number :8400025 (8.1 mi away) Contact
+173 other location
contraceptive use
brain lesion
teriflunomide
aubagio
hmr1726
pregnancy test urine

Summary

Primary Objective:

To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS

Secondary Objective:

To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168

Description

Study duration will vary per participant in this event driven trial with a treatment duration of approximately 18 to 36 months. Participants completing the study will be offered to participate in a long term safety study.

Details
Condition Relapsing Multiple Sclerosis
Treatment Teriflunomide HMR1726, SAR442168, Placebo to match SAR442168, Placebo to match Teriflunomide, Tolebrutinib, Placebo to match Tolebrutinib
Clinical Study IdentifierNCT04410991
SponsorSanofi
Last Modified on8 August 2022

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