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

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 any participants 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 primary hypogammaglobulinemia. Patients with a history of secondary hypogammaglobulinemia induced by anti-C20 monoclonal antibodies (eg, ocrelizumab, ofatumumab, ublituximab, rituximab) may be considered for study inclusion provided their immunoglobulin levels are within the normal limits (WNL) at time of Screening.
• •A history or presence of disease that can mimic MS symptoms, such as, but not limited 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 components thereof, 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.