A Study to Analyze SAR442168 in Participants with Nonrelapsing Secondary Progressive Multiple Sclerosis


About this study

This study aims to determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS and on clinical endpoints, MRI lesions, cognitive performance, physical function, and quality of life.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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, at

- The participant must have documented evidence of disability progression observed
during 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 regulations
regarding the methods of contraception for those participating in clinical studies

- A female participant is eligible to participate if she is not pregnant or
breastfeeding, 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 such as
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 or
latent tuberculosis or other active infections that would adversely affect study

- 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 dysfunctionat 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 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 during the

- The participant has received medications/treatments for MS within a specified time

- 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

B Mark Keegan, M.D.

Closed for enrollment

Contact information:

Christina McCarthy


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