A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)

简要总结

主要结局

次要结局

• Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response(At week 52)
• Proportion of participants who achieve both SRI(4) and BICLA (dual responders)(At week 52)
• Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score(At week 52)
• Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)(At week 52)
• Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints(At week 52)
• Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue(At week 52)
• Proportion of participants with oral corticosteroid (OCS) ≥ 7.5 mg/day of prednisone at baseline who are receiving ≤ 5 mg/day of prednisone at Week (Wk) 40 which is maintained through Wk52 and who achieve an SRI(4) response at Wk52.(At Week 52)
• Number of participants with adverse events (AEs)(Up to 156 weeks)
• Number of participants with serious adverse events (SAEs)(Up to 156 weeks)
• Number of participants with AEs leading to discontinuation of treatment(Up to 156 weeks)
• Number of participants with AEs leading to study discontinuation(Up to 156 weeks)
• Number of participants with target adverse events of special interest (AESIs)(Up to 156 weeks)
• Number of participants with laboratory abnormalities(Up to 156 weeks)
• Number of participants with electrocardiogram (ECG) abnormalities(Up to 156 weeks)
• Number of participants with vital sign abnormalities(Up to 156 weeks)