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

Inclusion Criteria:

1. Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8
2. 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 the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI >= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI >= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A >= 8
3. Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids

Other protocol defined inclusion criteria could apply

Exclusion Criteria:

1. Autoimmune or rheumatic disease other than SLE or CLE
2. Dermatological diseases other than cutaneous manifestations of SLE or CLE
3. Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
4. Ongoing or active clinically significant viral, bacterial, or fungal infection
5. History of uncontrolled seizures or other neurological disorder
6. History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
7. History of malignancy

Other protocol defined exclusion criteria could apply