A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 614
- 试验地点
- 295
- 主要终点
- Achievement of T-VASI 50 (≥ 50% reduction in T-VASI from Baseline) at Week 48
研究概览
简要总结
Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo (NSV). Adverse effects and change in disease activity will be assessed.
Upadacitinib is currently being investigated for the treatment of NSV. There will be 2 replicate studies running at the same time (Study 1 and Study 2 with periods A and B), an optional exploratory NB-UVB phototherapy study (Study 3), and a re-randomized dose-escalation study (Study 4). In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will receive placebo. In Period B, all participants will receive upadacitinib. Approximately 540 adult and adolescent participants with NSV will be enrolled between each main study at around 180 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI90 at week 48 while on study drug, to enter Study 3. Participants who failed to achieve T-VASI75 response at week 118 of Study 1 or 2 or at week 70 of Study 3 will be considered for entry into Study 4.
In Studies 1 and 2: Period A, participants will receive oral tablets of upadacitinib or placebo once a day for 48 weeks. In Period B, participants will receive oral tablets of upadacitinib 15 mg once a day for 112 weeks. Participants will be followed up for 30 days. Study 3 participants will receive upadacitinib monotherapy or upadacitinib with Narrow-Band Ultraviolet B (NB-UBV) phototherapy for at least 24 weeks followed by upadacitinib alone. In Study 4, participants will be re-randomized to receive oral tablets of upadacitinib 15 mg or 30 mg once a day for 56 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 65+ years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented clinical diagnosis of non-segmented vitiligo (NSV).
- •At Screening and Baseline Visits, participants must satisfy at least 1 of the following criteria:
- •>= 0.5 F-VASI and 5 <= T-VASI < 50 AND have failed at 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 sign of 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 could interfere with the assessment of vitiligo.
- •>33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (including the face).
结局指标
主要结局
Achievement of T-VASI 50 (≥ 50% reduction in T-VASI from Baseline) at Week 48
Achievement of T-VASI 50 (≥ 50% reduction in T-VASI from Baseline) at Week 48
Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 48
Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 48
次要结局
- Achievement of F-VASI 50 (≥ 50% reduction in F-VASI from Baseline) at Week 48;
- Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 24;
- Percent change from Baseline in F-VASI at Week 24;
- Percent change from Baseline in T-VASI at Week 48;
- Achievement of F-VASI 90 (≥ 90% reduction in F-VASI from Baseline) at Week 48;
- Achievement of VNS score of "A lot less noticeable (4)" or "No longer noticeable (5)" at Week 48;
- Achievement of PaGIC-V of "Much better (1)" at Week 48.
- Achievement of PhGIC-V of "Much better (1)" at Week 48;
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG