Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus

Exclusion Criteria

• •Systemic lupus erythematosus according to the 2012 SLICC criteria with major organ involvement.
• •Suspected or proven drug induced lupus erythematosus, including patients with positive antihistone autoantibody tests.
• •Autoimmune disease(s) other than systemic lupus erythematosus.
• •Active skin diseases that may interfere with the study or study assessments.
• •Exclusion related to tuberculosis, non-tuberculous mycobacterial infections, HIV, HBV, HCV, Herpes zoster, COVID-19 and other recurrent or recent serious infections.
• •Prolonged QTcF ≥ 450 ms (by Fridericia formula) or clinically significant findings on electrocardiogram (ECG).
• •Cannot avoid excessive UV exposure 4 weeks prior to baseline and during the study. Routine sun exposure through work are permitted but requires the use of sun block to sun exposed areas for at least 4 weeks prior to baseline and during the study.
• •Concomitant treatment with topical immunosuppressants beyond a stable regimen of low to medium potency topical corticosteroids and/or topical calcineurin inhibitors during the study and two weeks before baseline visit.
• •Initiation and/or changes in dosage of chloroquine/hydroxychloroquine within 12 weeks prior to Screening visit (or during Screening period) and/or the dose exceeding 2.3 mg/kg/day for chloroquine or 400 mg/day for hydroxychloroquine.
• •Systemic treatments for cutaneous or systemic lupus erythematosus or immunosuppressive therapy for autoimmune disease other than the study medication.
• •Systemic corticosteroids treatment \<4 weeks before baseline visit.
• •Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study.
• •Laboratory abnormalities at the Screening visit.
• •The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.