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 [M17-377]

AbbVie GK0 个研究点目标入组 272 人开始时间: 2018年9月14日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: AbbVie GK
入组人数: 272

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

The benefit-risk profile of both doses of upadacitinib in this study is assessed as favorable based on the safety and exploratory efficacy outcomes of the study.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 12age old 至 <= 75age old（—）
性别: All

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
•- 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

研究者

发起方

AbbVie GK

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