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

    Not Recruiting
  • End date
    Aug 28, 2023
  • participants needed
  • sponsor
Updated on 8 August 2022
contraceptive use
brain lesion
pregnancy test urine


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


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.

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

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