A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis

简要总结

主要结局

次要结局

• Proportion of subjects achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 from Baseline at Week 16 for subjects with pruritus NRS ≥4 at baseline;
• Proportion of subjects achieving EASI 90 at Week 16
• Percent change from Baseline of worst pruritus NRS at Week 16
• Percent change in EASI from Baseline at Week 16
• Proportion of subjects achieving an improvement (reduction) in worst pruritus NRS ≥ 4 from Baseline at Week 4 for subjects with pruritus NRS ≥ 4 at Baseline
• Proportion of subjects achieving EASI 75 at Week 4
• Proportion of subjects achieving EASI 75 at Week 2
• Proportion of subjects achieving EASI 90 at Week 4
• Proportion of subjects achieving an improvement (reduction) in worst pruritus NRS ≥ 4 from Baseline at Week 1 for subjects with pruritus NRS ≥ 4 at Baseline
• Proportion of subjects achieving an improvement (reduction) in Patient Oriented Eczema Measure (POEM) ≥ 4 from Baseline at Week 16 for subjects with POEM ≥ 4 at Baseline
• Proportion of subjects age ≥ 16 years old at screening achieving an improvement (reduction) in Dermatology Life Quality Index (DLQI) ≥ 4 from Baseline at Week 16 for subjects with DLQI ≥ 4 at Baseline
• Proportion of subjects achieving an improvement (reduction) in worst pruritus NRS ≥ 4 from Baseline at Day 2 for subjects with pruritus NRS ≥ 4 at Baseline (upadacitinib 30 mg vs. placebo)
• Proportion of subjects achieving an improvement (reduction) in worst pruritus NRS ≥ 4 from Baseline at Day 3 for subjects with pruritus NRS ≥ 4 at Baseline (upadacitinib 15 mg vs. placebo)
• Proportion of subjects achieving EASI 50 at Week 1
• Proportion of subjects experiencing a flare, characterized as a clinically meaningful worsening in EASI, defined as an increase of EASI by ≥ 6.6 from Baseline, during double-blind treatment period (DB Period)
• Proportion of subjects age ≥ 16 years old at screening achieving DLQI score of 0 or 1 at Week 16
• Percent change in Scoring Atopic Dermatitis (SCORAD) from Baseline at Week 16
• Change from Baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 16
• Proportion of subjects achieving a Hospital Anxiety and Depression Scale-anxiety (HADS-A) < 8 and Hospital Anxiety and Depression Scale depression (HADS-D) < 8 at Week 16 among subjects with HADS-A ≥ 8 or HADS-D ≥ 8 at Baseline
• Proportion of subjects achieving an improvement (reduction) in Atopic Dermatitis Impact Scale (ADerm-IS) sleep domain score ≥ minimal clinically important difference (MCID) from Baseline at Week 16 for subjects with ADerm-IS sleep domain score ≥ MCID at Baseline
• Proportion of subjects achieving an improvement (reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) skin pain score ≥ MCID from Baseline at Week 16 for subjects with ADerm-SS skin pain score ≥ MCID at Baseline
• Proportion of subjects achieving an improvement (reduction) in ADerm-SS 7-item total symptom score (TSS-7) ≥ MCID from Baseline at Week 16 for subjects with ADerm TSS-7 ≥ MCID at Baseline; ADerm-SS TSS-7 is defined as the algebraic sum of the responses to items 1 – 7 of the ADerm-SS
• Proportion of subjects achieving an improvement (reduction) in ADerm-IS emotional state domain score ≥ MCID from Baseline at Week 16 for subjects with ADerm-IS emotional state domain score ≥ MCID at Baseline
• Proportion of subjects achieving an improvement (reduction) in ADerm-IS daily activities domain score ≥ MCID from Baseline at Week 16 for subjects with ADerm-IS daily activities domain score ≥ MCID at Baseline
• Proportion of subjects achieving EASI 100 at Week 16
• Proportion of subjects achieving an improvement (reduction) in ADerm-SS TSS-7 ≥ MCID from Baseline at Week 4 for subjects with ADerm-SS TSS-7 ≥ MCID at Baseline
• Proportion of subjects achieving an improvement (reduction) in ADerm-IS sleep domain score ≥ MCID from Baseline at Week 4 for subjects with ADerm-IS sleep domain score ≥ MCID at Baseline
• Proportion of subjects achieving a vIGA-AD of 0 with a reduction from Baseline of ≥ 2 points at Week 16