Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)

Inclusion criteria :

• 18 to 60 years of age inclusive

• Diagnosis of nonrelapsing secondary progressive multiple sclerosis according to the 2017 McDonald criteria

• Expanded disability status scale (EDSS) between 3.0 to 6.5 points inclusive, atscreening

• The participant must have documented evidence of disability progression observedduring the 12 months before screening

• Absence of clinical relapses for at least 24 months

• Contraceptive use by men or women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies

• A female participant is eligible to participate if she is not pregnant orbreastfeeding, and at least one of the following conditions applies:

• Is not a WOCBP OR

• Is a WOCBP and agrees to use an acceptable contraceptive method

Exclusion criteria:

• The participant has conditions that would adversely affect study participation suchas short life expectancy.

• History of organ transplant.

• Evidence of infection with human immuodeficiency virus (HIV), transplantation,progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active orlatent tuberculosis or other active infections that would adversely affect studyparticipation.

• Persistent chronic or active or recurring system infection, that may adverselyaffect participation or IMP administration in this study, as judged by theInvestigator.

• 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

• Bleeding disorder, known platelet dysfunctionat any time prior to the screeningvisit

• 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 orgastrointestinal bleeding.

• 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 duringthe study.

• The participant has received medications/treatments for MS within a specified timeframe.

• Receiving potent and moderate inducers or inhibitors 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).

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