EUCTR2018-002264-57-ES进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects with Moderate to Severe Atopic Dermatitis - Heads UP
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 692
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female subjects 18 years old and 75 years old
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Prior exposure to any JAK inhibitor or Dupilumab
- •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
研究者
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This is a Phase 3, randomized, multi-center study that will evaluate upadacitinib versus dupilumab in adults (18 – 75 years of age) with moderate to severe AD who are candidates for systemic therapy. The study is comprised of a 35-day Screening Period, a 24-week blinded treatment period, and a 12-week Follow-up period.moderate to severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2018-002264-57-HRAbbVie Deutschland GmbH & Co. KG650