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

Exclusion Criteria

• •Participants are excluded from the study if any of the following criteria apply:
• •Participant has conditions that would adversely affect study participation such as short life expectancy.
• •Evidence of infection with human immunodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation.
• •Persistent chronic or active or recurring system infection that may adversely affect participation or IMP administration in this study as judged by the investigator
• •History of malignancy within 5 years prior to screening.
• •History of alcohol or drug abuse within 1 year prior to Screening.
• •Hospitalized for psychiatric disease within 2 years prior to Screening.
• •Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.
• •A bleeding disorder or known platelet dysfunction at any time prior to the screening visit.
• •A platelet count \<150 000/μL at the screening visit.
• •A history of significant bleeding event within 6 months prior to screening, according to the Investigator's judgment such as, but not limited to cerebral or gastrointestinal
• •Lymphocyte count below the lower limit of normal at Screening.
• •Recent live (attenuated) vaccine within 2 months before the first treatment visit.
• •Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study.
• •The participant has received medications/treatments for MS within a specified time frame.
• •Receiving potent and moderate inducers of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes.
• •Receiving anticoagulant or antiplatelet therapy (such as aspirin \>81mg/day, clopidogrel, warfarin).
• •Contraindications to magnetic resonance imaging (MRI).