jRCT2031230663进行中（未招募）不适用
A Phase 3, Randomized, Placebo-Controlled, Double-BlindStudy to Evaluate the Efficacy, Safety, and Tolerability ofUpadacitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AbbVie GK
- 入组人数
- 450
- 主要终点
- Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI)50
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
- Double Blind
入排标准
- 年龄范围
- 12age old over 至 No limit（—）
- 性别
- All
入选标准
- •Documented clinical diagnosis of non-segmented vitiligo(NSV).
- •At Screening and Baseline Visits, participants must satisfyat least 1 of the following criteria:
- •- >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have failedat least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for vitiligo; or
- •- >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have a signof actively progressing vitiligo; or
- •- >= 0.5 F-VASI and 10 <= T-VASI < 50.
排除标准
- •Segmental or localized vitiligo.
- •History of active skin disease other than vitiligo that couldinterfere with the assessment of vitiligo.
- •>33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (includingthe face).
结局指标
主要结局
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI)50
时间窗: week 48
50% Improvement in T-VASI From Baseline
Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI)75
时间窗: week 48
75% Improvement in F-VASI From Baseline
次要结局
- Percentage of Participants Achieving F-VASI 50(week48)
- Percentage of Participants Achieving T-VASI 75(week 48)
- Percentage of Participants Achieving F-VASI 75(week 24)
- Percentage of Participants Achieving F-VASI 90(week 48)
- Percentage of Participants Achieving Patient Global Impression of Severity of Vitiligo Sun Sensitivity Score of "Not Sensitive at All (0)" or "Mildly Sensitive (1)"(week 48)
- Percentage of Participants Achieving Patient Global Impression of Noticeability(PGIN) Score of "Not Noticeable at All (0)" or "A Little Noticeable (1)"(week 48)
- Percentage of Participants Achieving 3D Imaging Facial Vitiligo 40(week 48)
研究者
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