Elowen-1: A Study of Enpatoran in Cutaneous Manifestations of Lupus With or Without Systemic Disease

INTERVENTION: Enpatoran Placebo CONDITION: ; Immunology Immunology PRIMARY OUTCOME: The primary endpoint, CLASI 70 response at Week 24, will be tested at a 1 sided a level of 0.025. The null hypothesis of no treatment effect:; H01: the risk difference in CLASI‐70 at Week 24 for enpatoran versus placebo, will be tested against the alternative hypothesis is ; SECONDARY OUTCOME: Demonstrate the effect of enpatoran on Worst Skin Pain NRS ; Endpoint: Change from Baseline in Worst Skin Pain NRS at Week 24 ; To demonstrate the effect of enpatoran in preventing worsening of cutaneous disease ; Endpoint: Proportion of patients with no worsening in CLASI‐A score from Baseline at Week 24 ; To demonstrate the effect of enpatoran on reaching low cutaneous disease activity level ; Endpoint: Achievement of CLA‐IGA‐R Erythema of 0 or 1 at Week 24 ; To demonstrate the efficacy of enpatoran in reducing systemic disease activity and CS use ; Endpoint: BICLA response and clinically meaningful CS reduction, defined as reduction of daily prednisone‐equivalent dose from = 10 mg at Day 1 to = 5 mg by the Week 12 visit and sustained through Week 24 ; To demonstrate the efficacy of enpatoran in the achievement of low cutaneous disease activity/remission at Week 24 ; Endpoint: CLASI‐A = 3 at Week 24 ; To demonstrate the fast onset of action of enpatoran in reducing cutaneous disease by achieving at least 50% reduction from Baseline in CLASI‐A total score (CLASI 50) at Week 4 ; Endpoint: CLASI‐50 response at Week 4 ; To evaluate safety and tolerability of enpatoran ; Endpoint: From Day 1 to Week 24: ; • Occurrence of TEAEs, SAEs, and AESI ; • Occurrence of abnormalities (= Grade 3) in laboratory parameters ; To evaluate the efficacy of enpatoran in reducing cutaneous disease activity in CLASI A mucosal ulcer subscale ; Endpoint: Proportion of participants with CLASI‐A mucosal ulcers at Week 24 ; To evaluate the efficacy of enpatoran on disease control in participants with active SLE ; Endpoint: SRI‐4 response at Week 24 ; To evaluate the efficacy of enpatoran on reduction of cutaneous disease activity ; Endpoint: CLASI‐50 response at Week 24 ; INCLUSION CRITERIA: = 18 to = 75 years of age at the time of signing the informed consent. Are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory. Cutaneous manifestation criteria: • Diagnosis of DLE and/or SCLE documented in medical history, with or without SLE. • Active ACLE as sole cutaneous manifestations is allowed in the presence of SLE (meeting criterion 4) and should be present for at least 6 weeks prior to the Screening visit. • Other skin manifestations will be allowed (e.g. lupus tumidus, lupus profundus, Chilblain lupus, etc.) on a case‐by‐case basis if the main diagnosis is active DLE, SCLE, and/or ACLE, as described above. Confirmation of diagnosis must include 1 of the following options: a. Pathology report from punch or shave biopsy within 10 years prior to Screening visit and confirmation of current diagnosis by mandatory skin photography at Screening visit. OR b.