A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 444
- 试验地点
- 109
- 主要终点
- Proportion of subjects achieving validated IGA scale for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from baseline at Week 16
研究概览
简要总结
To assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult subjects with moderate to severe AD who are candidates for systemic therapy. To assess the long-term (10 years) efficacy and safety of upadacitinib for the treatment of adolescent and adult subjects with moderate to severe AD who are candidates for systemic therapy.
研究设计
- 分配方式
- Randomized
- 主要目的
- Extension Period of up to Week 524
- 盲法
- Double (Subject, Carer, Investigator, Analyst, Monitor)
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects 12-75 years of age
- •Active moderate to severe atopic dermatitis defined by EASI, IGA, BSA, and pruritus
- •Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis
- •Able to tolerate topical corticosteroids for atopic dermatitis lesions
排除标准
- •Prior exposure to any JAK inhibitor
- •Unable or unwilling to discontinue current AD treatments prior to the study
- •Requirement of prohibited medications during the study
- •Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
- •Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
结局指标
主要结局
Proportion of subjects achieving validated IGA scale for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from baseline at Week 16
Proportion of subjects achieving validated IGA scale for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from baseline at Week 16
Proportion of subjects achieving improvement from baseline of at least 75% on Eczema Area Severity Index (EASI 75) at Week 16.
Proportion of subjects achieving improvement from baseline of at least 75% on Eczema Area Severity Index (EASI 75) at Week 16.
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 Worst Pruritus NRS ≥ 4 at Baseline
- Proportion of subjects achieving a 90% reduction in EASI (EASI 90) at Week 16
- Percent change from Baseline of Worst Pruritus NRS at Week 16
- Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS ≥ 4 from Baseline at Week 4 for subjects with Worst 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 EASI 100 at Week 16 for 30 mg
- Percent change in EASI score from Baseline at Week 16.
- Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS ≥ 4 from Baseline at Week 1 for subjects with Worst Pruritus NRS ≥ 4 at Baseline.
研究者
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG