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

Eligibility 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.
• * 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