Lead Sponsor

Gilead Sciences

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

•Either fulfill the European League Against Rheumatism (EULAR)/ American College of Rheumatology(ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) or have biopsy-proven cutaneous lupus erythematosus (CLE).
•Must have active acute cutaneous lupus erythematosus (ACLE)/ subacute cutaneous lupus erythematosus (SCLE); individuals with mixed skin presentations of lupus skin disease (including DLE) are allowed to enter.
•CLE Disease Area and Severity Index (CLASI) activity score of ≥ 6 during screening and Day 1, excluding the alopecia component.
•Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and willingness to undergo skin biopsy at 2 time points.
•Protocol-permitted nonbiologic immunosuppressive/immunomodulatory agents for the treatment of CLE/SLE (eg, antimalarials, methotrexate (MTX), or other conventional synthetic disease-modifying antirheumatic drug (csDMARDs)) must maintain stable dose(s) for ≥ 60 days prior to randomization through Week 4 of the study.

•Dermatologic disease other than cutaneous manifestations of SLE or CLE that may interfere with assessment of lupus-specific skin lesions.
•Ongoing or active clinically significant bacterial, fungal or viral infection.
•History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus.
•Uncontrolled health conditions including highly active SLE (e.g. lupus nephritis, neuropsychiatric SLE, vasculitis etc.).
•History of malignancy.

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