R-Pharm Germany GmbH

Primary objective: To evaluate the long-term safety and tolerability of enpatoran in subjects with SCLE, DLE and/or SLE. Secondary objectives: To evaluate the long-term safety and tolerability of enpatoran in subjects with SCLE, DLE and/or SLE and the long-term effectiveness of enpatoran in disease control; Tertiary/exploratory objectives: To evaluate the long-term effectiveness of enpatoran in disease control in subjects with SCLE, DLE and/or SLE; To evaluate the long-term effectiveness of enpatoran in disease control in subjects with SLE; To evaluate the long-term effectiveness of enpatoran in patient-reported symptoms and functional status in subjects with SCLE, DLE and/or SLE; To evaluate the long-term effectiveness of enpatoran in patient-reported symptoms and functional status in subjects with active SLE; To study the effects of enpatoran on biomarkers in subjects with active SLE; To study the effects of enpatoran on immune cell subsets and immunoglobulins; To study the effects of enpatoran on PD biomarkers; To collect enpatoran plasma concentration data by sparse PK sampling; To evaluate the long-term effects of enpatoran on vaccine immune status. To evaluate the effects of Enpatoran versus placebo on erythema in subjects with active lupus rash.

Primary objectives: To evaluate the dose-response relationship of Enpatoran in reducing disease activity based on CLASI-A; To evaluate the dose-response relationship of Enpatoran in reducing disease activity based on BICLA response rate; Secondary objectives: To evaluate the safety and tolerability of Enpatoran compared with placebo; To evaluate the efficacy of Enpatoran compared with placebo in disease control in lupus subjects with active lupus rash; To demonstrate that Enpatoran is more effective than placebo in patients receiving ≥10 days of prednisone on day 1. mg in achieving BICLA response and clinically meaningful CS reduction in SLE subjects; Evaluate the effectiveness of Enpatoran compared with placebo in disease control in lupus subjects with active lupus rash; Evaluate the effectiveness of Enpatoran compared with placebo in disease control in active SLE subjects; Evaluate the effectiveness of Enpatoran compared with placebo in patient-reported symptoms and functional status in lupus subjects with active lupus rash; Evaluate the effectiveness of Enpatoran compared with placebo in patient-reported symptoms in active SLE subjects. And related exploratory objectives.