Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

Inclusion Criteria:

• Participant must have a previous diagnosis of RRMS in accordance with the 2017revised McDonald criteria.

• Participant must have a current diagnosis of SPMS in accordance with the clinicalcourse criteria revised in 2013 endorsed by an Adjudication Committee.

• Participant must have documented evidence of disability progression observed duringthe 12 months before screening. Eligibility will be analyzed by an AdjudicationCommittee.

• Absence of clinical relapses for at least 24 months.

• The participant must have an EDSS score at screening from 3.0 to 6.5 points,inclusive.

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

• For patients eligible to be treated with siponimod: 1) does not tolerate it due toside effects or safety reasons, or 2) has failed siponimod treatment due toperceived lack of efficacy, or 3) has declined siponimod treatment.

Exclusion Criteria:

• The participant has a history of infection or may be at risk for infection.

• The presence of psychiatric disturbance or substance abuse.

• History, clinical evidence, suspicion or significant risk for thromboembolic events,as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and anyparticipants requiring antithrombotic treatment.

• Current hypogammaglobulinemia defined by immunoglobulin levels (IgG and/or IgM)below the lower limits of normal (LLN) at Screening or a history of primaryhypogammaglobulinemia. Patients with a history of secondary hypogammaglobulinemiainduced by anti-C20 monoclonal antibodies (eg, ocrelizumab, ofatumumab, ublituximab,rituximab) may be considered for study inclusion provided their immunoglobulinlevels are within the normal limits (WNL) at time of Screening.

• A history or presence of disease that can mimic MS symptoms, such as, but notlimited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus,Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.

• The participant has sensitivity to any of the study interventions, or componentsthereof, or has a drug or other allergy that, in the opinion of the Investigator,contraindicates participation in the study.

• The participant was previously exposed to frexalimab.

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