Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis

Primary Objective:

To determine the long-term safety and tolerability of SAR442168 in RMS participants

Secondary Objective:

To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods

Approximately 62 months including the 8 weeks post-treatment visit

Inclusion criteria:

• Participants had to have completed treatment in the DRI15928 study
• Female participants had to continue to use an acceptable effective contraception method of birth control from inclusion and until the last dose of study drug, except if she had undergone sterilization at least 3 months earlier or was postmenopausal. Menopause was defined as being amenorrheic for ≥12 months with plasma follicle stimulating hormone (FSH) level >30 UI/L.
• The participant had to have given written informed consent prior to undertaking any study related procedure.

Exclusion criteria:

• The participant had a confirmed concomitant laboratory or ECG abnormality or medical condition deemed by the investigator incompatible with continuation of SAR442168 treatment.

• The participant had received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) between the last DRI15928 visit and the first treatment visit in the LTS16004 study.

• The participant had received a non-study MS disease modifying treatment between the last IMP treatment in Study DRI15928 and inclusion in Study LTS16004, which by judgement of the Investigator may add unjustified risk to switching back and continuing treatment with SAR442168. Washout periods after treatment with non-study DMTs had to be respected except for interferons or glatiramer acetate treatment.

• The participant was receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.

• The participant was receiving anticoagulant/antiplatelet therapies, including:

  • Acetylsalicylic acid (aspirin)
  • Antiplatelet drugs (eg, clopidogrel)
  • Warfarin (vitamin K antagonist)
  • Heparin, including low molecular weight heparin (antithrombin agents)
  • Dabigatran (direct thrombin inhibitor)
  • Apixaban, edoxaban, rivaroxaban (direct factor Xa inhibitors)

Note: All above drugs needed to be stopped at least 5 half-lives before study drug administration except for aspirin, which needed to be stopped at least 8 days beforehand.

• Prior/concurrent clinical study experience. The participant was taking part in another interventional clinical trial of another drug substance.
• Uncooperative behavior or any condition that could make the participant potentially non-adherent with the study procedures
• The participant was pregnant or was a breastfeeding woman.

The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.