Ensayos clínicos

Inclusion criteria :

- 18 to 55 years of age inclusive

- Diagnosis of PPMS according to the 2017 McDonald criteria

- Expanded disability status scale (EDSS) between 2.0 to 6.5 points, inclusive at
screening

- Disease duration from the onset of MS symptoms of <15 years if screening EDSS score of
>5.0 OR <10 years if screening EDSS score of ≤5.0.

- Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG)
index either during screening or documented previous history.

- Contraceptive use consistent with local regulations for individuals participating in
clinical studies

- Participant is eligible to participate if she is not pregnant or breastfeeding, and at
least one of the following conditions applies:

- Is not a woman of child bearing potential (WOCBP) OR

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

Exclusion criteria:

- 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.

- Bleeding disorder, known platelet dysfunction at any time prior to the screening visit

- A platelet count <150 000/?L 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 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/5/22. Questions regarding updates should be directed to the study team contact.