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 RevisedCriteria for Classification of SLE according to the 1997 Update of the 1982 ACRcriteria

• 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 asconfirmed by a Sponsor-selected independent reviewer(s)

• At least 1 BILAG A score or 2 BILAG B scores during screening as confirmed by aSponsor-selected independent reviewer(s)

• Receiving at least one of the standard of care (SOC) for SLE (combination ispossible)

• Body weight within 45 kg to 120 kg (inclusive) at screening

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

Exclusion Criteria:

• Primary diagnosis of a rheumatic disease besides SLE or an inflammatory joint orskin 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 toseizures, psychosis, acute confusional state, transverse myelitis, central nervoussystem vasculitis and optic neuritis

• Known or suspected drug-induced lupus

• History, clinical evidence, suspicion or significant risk, for thromboembolicevents, as well as myocardial infarction, stroke, and/or antiphospholipid syndromeand 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 notlimited 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 torandomization

• High dose of immunosuppressants or a change in dose within 12 weeks prior torandomization

• Use of cyclophosphamide within 3 months prior to screening

• Previous parenteral (IV), intramuscular (IM), or intra-articular steroidadministration within 4 weeks prior to randomization

• Participants likely to require multiple courses of oral corticosteroid (OCS) duringthe study for chronic diseases other than SLE

• Administration of any live (attenuated) vaccine within 3 months prior torandomization (eg, varicella zoster vaccine, oral polio, rabies)

• Administration of any non-live vaccine (eg, seasonal influenza, COVID-19) within 4weeks prior to randomization

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