A Phase 3 Randomized, Multicenter, Double-Blind Study to Evaluate the Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects in Japan With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 272
- 试验地点
- 43
- 主要终点
- Number of participants experiencing adverse events
研究概览
简要总结
The objective of this study is to assess the safety of upadacitinib combined with topical corticosteroids (TCS) in adolescent and adult participants in Japan with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (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 Janus kinase (JAK) inhibitor.
- •Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study.
- •Requirement of prohibited medications during the study.
- •Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
研究组 & 干预措施
Arm A
Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS).
干预措施: Upadacitinib (Drug)
Arm A
Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS).
干预措施: Topical Corticosteroids (TCS) (Drug)
Arm B
Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS).
干预措施: Upadacitinib (Drug)
Arm B
Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS).
干预措施: Topical Corticosteroids (TCS) (Drug)
Arm C
Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.
干预措施: Upadacitinib (Drug)
Arm C
Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.
干预措施: Placebo for upadacitinib (Drug)
Arm C
Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.
干预措施: Topical Corticosteroids (TCS) (Drug)
Arm D
Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.
干预措施: Upadacitinib (Drug)
Arm D
Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.
干预措施: Placebo for upadacitinib (Drug)
Arm D
Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.
干预措施: Topical Corticosteroids (TCS) (Drug)
结局指标
主要结局
Number of participants experiencing adverse events
时间窗: Up to 141 Weeks
Adverse events are defined as those that began or worsened in severity after the first dose of study drug but within 30 days after the last dose of study drug.
次要结局
未报告次要终点