Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus

Inclusion Criteria: * Diagnosis of SLE for at least 6 months prior to screening by fulfilling the Revised Criteria for Classification of SLE according to the 1997 Update of the 1982 ACR criteria * Positive antinuclear antibody (ANA) (titer ≥1:80) during screening * Positivity for at least one serological characteristic * Total hSELENA-SLEDAI score ≥6 (including points attributed from arthritis and rash) during screening and at least 4 points from clinical features at randomization as confirmed by a Sponsor-selected independent reviewer(s) * At least 1 BILAG A score or 2 BILAG B scores during screening as confirmed by a Sponsor-selected independent reviewer(s) * Receiving at least one of the standard of care (SOC) for SLE (combination is possible) * Body weight within 45 kg to 120 kg (inclusive) at screening * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * Primary diagnosis of a rheumatic disease besides SLE or an inflammatory joint or skin disease other than SLE that could confound the disease activity assessments * Active and severe lupus nephritis * Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis * Known or suspected drug-induced lupus * History, clinical evidence, suspicion or significant risk, for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment * History or current hypogammaglobulinemia * Serious systemic viral, bacterial or fungal infection * Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution * Evidence of active or untreated latent tuberculosis as documented by medical history (eg, chest Xrays) and examination, and tuberculosis testing * High dose of steroids, or a change in dose within 4 weeks prior to randomization * High dose of antimalarial, or a change in dose within 12 weeks prior to randomization * High dose of immunosuppressants or a change in dose within 12 weeks prior to randomization * Use of cyclophosphamide within 3 months prior to screening * Previous parenteral (IV), intramuscular (IM), or intra-articular steroid administration within 4 weeks prior to randomization * Participants likely to require multiple courses of oral corticosteroid (OCS) during the study for chronic diseases other than SLE * Administration of any live (attenuated) vaccine within 3 months prior to randomization (eg, varicella zoster vaccine, oral polio, rabies) * Administration of any non-live vaccine (eg, seasonal influenza, COVID-19) within 4 weeks prior to randomization The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.