Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active SLE (POETYK SLE-1)

Prior treatment

• Participants with any of the following diagnoses are excluded: drug induced SLE, most autoimmune disease (e.g. multiple sclerosis, inflammatory bowel disease, etc), SLE overlap syndromes including rheumatoid arthritis, scleroderma and mixed connective tissue disease, catastrophic anti-phospholipid syndrome or anti-phospholipid syndrome not maintained on appropriate therapy or there has been a thrombotic event or pregnancy morbidity, active severe lupus nephritis, active severe neuropsychiatric lupus, congenital or acquired immunodeficiency condition. Participants on investigational agents or prohibited immunomodulatory or biologics medications within applicable wash-out period are excluded. Participants using prohibited corticosteroid formulations or prohibited routes of administration (e.g. modified release CS formulation, high-potency topic CS, intramuscular, intra-articular, intra-bursal, and IV), receiving therapy for active or chronic infection are also excluded.

• Male and female participants aged 18(or local age of majority, if older) to 75 years of age, inclusive, diagnosed with SLE at least 24 weeks prior to screening and meet the European Alliance of Associations for Rheumatology/American College of Rheumatology 2019 classification criteria for SLE. Participants must test positive for at least 1 of the following lupus-related autoantibodies at the time of screening: antinuclear antibodies (ANA)≥ 1:80, anti-dsDNA antibody, or anti-Smith (anti- Sm). Participants must have active lupus defined as a total SLEDAI-2K score≥6 points, and clinical SLEDAI-2K score ≥ 4 points, and must include joint involvement and/or cutaneous vasculitis, and/or rash. Participants must be on stable background therapy with anti-malarial agents and/or immunosuppressants. Participants may also be on corticosteroids.