Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Inclusion Criteria:

• Signed Informed Consent Form prior to any study-mandated procedure

• Diagnosis of SLE made at least 6 months prior to Screening, by fulfilling at least 4of the 11 criteria for SLE as defined by the American College of Rheumatology (ACR)criteria

• A mSLEDAI-2K score ≥ 6 of at least 2 points for musculoskeletal or mucocutaneousmanifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).

• Currently treated with stable doses of one or more of the following backgroundmedications:

• NSAIDs

• Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine)

• Mycophenolate mofetil (≤ 2 g/day)

• Mycophenolic acid (≤ 1440 mg/day)

• Azathioprine (≤ 2 mg/kg/day)

• Methotrexate (≤ 20 mg/week)

• Corticosteroids (≤ 40 mg/day prednisone or equivalent)

• Belimumab (≤10 mg/kg every 4 weeks intravenously, or 200 mg/weeksubcutaneously).

• History or presence of positive autoantibodies measured by central laboratorydefined as follows: (a) Positive antinuclear antibody (ANA) test measured byimmunofluorescence assay (IFA) with titre ≥1:80; AND/OR (b) positive anti-doublestranded deoxyribonucleic acid (anti-dsDNA) antibodies with titre ≥30 IU/mL

• Women of childbearing potential:

• Must have a negative serum pregnancy test at Screening

• Must agree to undertake monthly urine pregnancy tests during the study

• Must use highly effective methods of contraception from the screening visituntil 6 months after taking the last dose of study treatment.

Exclusion Criteria:

• Active lupus nephritis or a renal biopsy demonstrating immune complex mediatedglomerulonephritis compatible with lupus nephritis.

• CNS (Central Nervous System) lupus and severe forms of vasculitis requiring systemicimmunosuppressive treatment

• A diagnosis of mixed connective tissue disease or any history of overlap syndromesof SLE with rheumatoid arthritis, erosive arthritis, scleroderma or autoimmunehepatitis

• History or presence of Mobitz type II or third-degree atrioventricular block, sicksinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders

• Subjects who experienced myocardial infarction, unstable angina pectoris, stroke,transient ischemic attack, vascular thrombosis, decompensated heart failurerequiring hospitalization, or heart failure defined by the New York HeartAssociation Class III/IV within six months prior to Screening

• An elevated QT corrected for HR (Heart Rate) on the basis of Fridericia's formulainterval of > 470 ms (females) / > 450 ms (males)

• History or presence of severe respiratory disease or pulmonary fibrosis

• Active or latent tuberculosis

• Ongoing bacterial, viral or fungal infection that is of clinical concern in thejudgment of the investigator or history of any serious infection

• Subjects who have congenital or acquired severe immunodeficiency or known HIVinfection or positive HIV testing

• Presence of macular edema or active uveitis

• Type 1 or 2 diabetes that is poorly controlled according to investigator judgment,or diabetes complicated with organ involvement such as diabetic nephropathy orretinopathy

• Significant hematology abnormality: Lymphocyte count < 800 /μL (0.8 × 10e9/L);hemoglobin < 9 g/dL; WBC (White Blood Cell) count < 2500/μL (2.5 × 10e9/L) orplatelets < 75000/μL (75 × 10e9/L)

• Estimated glomerular filtration rate < 60 mL/min/1.73 m2

• Known allergy to S1P (sphingosine-1-phosphate) receptor modulators or any of thecenerimod formulation excipients