2023-504869-23-00已完成4 期
A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis (Flex-Up)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 63
- 主要终点
- Achievement of EASI 90 at Week 24
研究概览
简要总结
- Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the efficacy and safety of dose escalation to upadacitinib 30 mg QD in subjects who do not achieve Eczema Area and Severity Index (EASI) 90 on upadacitinib 15 mg QD after 12 weeks.
- Sub-Study 2 (SS2): The primary study objective for SS2 is to evaluate the efficacy and safety of dose reduction to upadacitinib 15 mg QD in subjects who achieve EASI 90 on upadacitinib 30 mg QD after 12 weeks. No hypothesis testing will be performed in this study.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- 12 Week Single Blind Period
- 盲法
- Single (Subject)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects ≥18 and < 65 years of age at the Screening Visit
- •Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria
- •Candidate for systemic treatment
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 treatment
- •Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
结局指标
主要结局
Achievement of EASI 90 at Week 24
Achievement of EASI 90 at Week 24
次要结局
- Achievement of EASI 75 / 100 at Week 24.
- Achievement of EASI 75 / 90 / 100 at Week 12.
- Achievement of EASI 90 and a Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12 and Week 24.
- Achievement of a vIGA-AD of 0 or 1 at Week 12.
- Achievement of vIGA-AD of 0 or 1 at Week 24.
- Achievement of an improvement (reduction) in Worst Pruritus NRS ≥ 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline at Week 12.
- Achievement of an improvement (reduction) in Worst Pruritus NRS ≥ 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline at Week 24.
- Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12.
- Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 24.
- Achevement of an improvement (reduction) from Baseline in DLQI ≥4 for subjects with DLQI ≥ 4 at Baseline at Week 12.
- Achievement of an improvement (reduction) from Baseline in DLQI ≥4 for subjects with DLQI ≥ 4 at Baseline at Week 24.
- Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 12.
- Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 24.
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (63)
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