Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
Brief description of study
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Primary Progressive Multiple Sclerosis
Age: Between 18 Years - 55 Years
Gender: Male or Female
- 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
- 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/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 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.
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