jRCT2011230002招募中不适用
[M23-696]A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to Severe Atopic Dermatitis (Level-Up)
AbbVie G.K.0 个研究点目标入组 880 人开始时间: 2023年7月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 880
- 主要终点
- Percentage of Participants Achieving both 90% Eczema Area and Severity Index (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1(WPNRS 0/1)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 12age old over 至 64age old under（—）
- 性别
- All
入选标准
- •Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria.
- •Eczema area and severity index (EASI) score 16: validated Investigators Global Assessment for AD (vIGA-AD) score 3 and 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.
- •Baseline weekly average of daily Worst Pruritus Numerical Rating Scale (WP-NRS)
- •Documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for AD OR for whom other systemic treatments are otherwise medically inadvisable.
排除标准
- •History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
- •History of an organ transplant which requires continued immunosuppression.
结局指标
主要结局
Percentage of Participants Achieving both 90% Eczema Area and Severity Index (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1(WPNRS 0/1)
时间窗: At week 16
Percentage of participants achieving both: - 90% reduction in Eczema Area and Severity Index (EASI 90) - Worst Pruritus Numerical Rating Scale of 0 or 1 (WPNRS 0/1)
次要结局
- Percentage of Participants Achieving an improvement in Worst Pruritus Numerical Rating Scale (WP-NRS) 4 among those with Baseline WP-NRS 4(At week 16)
- Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) among Participants with Baseline WP-NRS > 1(Up to week 16)
- Percentage of Participants Achieving 75% of Eczema Area and Severity Index(EASI 75)(At week 2)
- Percentage of Participants Achieving 100% of Eczema Area and Severity Index(EASI 100)(At week 16)
- Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90)(Up to week 16)
研究者
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