The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

Inclusion Criteria:

• Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8

• Active SLE with presence of: CLASI-A >= 8 and BILAG 2004 1B, C, D (that is [i.e.],No BILAG 2004 A and No BILAG 2004 >= 2B) or BILAG 2004 >= 1A or 2B and 1 or 2 of thefollowing: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus NationalAssessment (SELENA)-SLEDAI >= 6 at Screening Visit and confirmed clinical hybridSELENA-SLEDAI >= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A >= 8

• Receiving a stable dose of at least one of the following standards of care therapiesfor lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topicalcorticosteroids

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Autoimmune or rheumatic disease other than SLE or CLE

• Dermatological diseases other than cutaneous manifestations of SLE or CLE

• Uncontrolled medical conditions including significant cardiovascular events, activelupus nephritis, and active neurological disorder

• Ongoing or active clinically significant viral, bacterial, or fungal infection

• History of uncontrolled seizures or other neurological disorder

• History of or positive for human immunodeficiency virus, hepatitis C virus, orhepatitis B virus

• History of malignancy

• Other protocol defined exclusion criteria could apply