A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Children and Adolescents From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis

简要总结

主要结局

次要结局

• Trough concentration at steady state (Cminss)(At week 16)
• Time-averaged steady-state concentration (Cavgss)(At week 16)
• Steady-state maximum observed concentration (Cmaxss)(At week 16)
• Number of participants with flare during the withdrawal period(From week 16 up to week 42)
• Number of participants achieving each of American College of Rheumatology (ACR) Pedi (30/50/70/90)(At week 16 and week 42)
• Change from baseline in juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) Pedi Core Criteria(At week 16 and week 42)
• Number of participants achieving low disease activity (Juvenile arthritis disease activity 71-joint score based on C-reactive protein (JADAS71-CRP) score: for oligoarthritis 1.1 to 2; for polyarthritis 1.1 to 3.8)(At week 16 and week 42)
• Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1)(At week 16 and week 42)
• Number of participants attaining clinical remission for at least 6 consecutive months(At week 42)
• Number of participants achieving psoriasis area and severity index (PASI) 75(At week 42)
• Number of participants for each assessment who evaluate palatability scale as ≥ 3 (good or better), swallowability scale as ≤ 4 (neutral or easier), and taste scales (Sweetness, Bitterness, Flavor, and Overall Taste) as "None" or "Weak"(At week 16)
• Assessment of exposure-response (E-R) utilizing steady-state exposure of deucravacitinib from the pharmacokinetic (PK) analysis and efficacy results using ACR Pedi 30(At week 16)
• Number of participants with adverse events (AEs)(Up to week 42)
• Number of participants with adverse event of special interest (AESIs)(Up to week 42)
• Number of participants with AEs leading to discontinuation(Up to week 42)
• Number of participants with serious adverse events (SAEs)(Up to week 42)
• Number of participants with Uveitis(Up to week 42)
• Number of participants achieving low disease activity (Juvenile arthritis disease activity 71-joint score based on C-reactive protein (JADAS71-CRP) score: for oligoarthritis 1.1 to 2; for polyarthritis 1.1 to 3.8)(Through week 16 and up to week 42)
• Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1)(Through week 16 and up to week 42)
• Number of participants achieving each of juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) (30/50/70/90)(Through week 16 and up to week 42)
• Change from baseline in juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) Core Criteria(Through week 16 and up to week 42)
• Assessment of exposure-response (E-R) utilizing steady-state exposure of deucravacitinib from the pharmacokinetic (PK) analysis and efficacy results using JIA-ACR 30(At week 16)