A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-Takayasu)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
- 试验地点
- 89
- 主要终点
- Time to First Relapse of Takayasu Arteritis (TAK) From Baseline through End of the Double-Blind (DB) Period
研究概览
简要总结
The main objective of this study is to evaluate the efficacy of upadacitinib in combination with a corticosteroid taper regimen compared to placebo in combination with a corticosteroid taper regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be at least 18 years of age (at least 15 years of age in Japan)
- •Clinical diagnosis of TAK and fulfilling the Japanese Guidelines for Management of Vasculitis Syndrome 2017 criteria.
- •Participant must have experienced a relapse of TAK within 12 weeks of Baseline despite being on treatment with oral corticosteroid.
- •Participants must be in remission and on a stable corticosteroid dose prior to Baseline.
排除标准
- •Treatment with an interleukin-6 (IL-6) inhibitor or Janus Kinase (JAK) inhibitor (including but not limited to tocilizumab, sirukumab, sarilumab, upadacitinib, tofacitinib, baricitinib, ruxolitinib, peficitinib, and filgotinib) within 4 weeks of Baseline.
- •Current use of immunomodulators other than corticosteroids.
研究组 & 干预措施
Arm 1: Upadacitinib
Participants will be administered updadacitinib once daily (QD) along with prednisolone.
干预措施: Upadacitinib (Drug)
Arm 1: Upadacitinib
Participants will be administered updadacitinib once daily (QD) along with prednisolone.
干预措施: Prednisolone (Drug)
Arm 2: Placebo for Upadacitinib
Participants will be administered placebo once daily (QD) along with prednisolone.
干预措施: Upadacitinib (Drug)
Arm 2: Placebo for Upadacitinib
Participants will be administered placebo once daily (QD) along with prednisolone.
干预措施: Placebo for Upadacitinib (Drug)
Arm 2: Placebo for Upadacitinib
Participants will be administered placebo once daily (QD) along with prednisolone.
干预措施: Prednisolone (Drug)
结局指标
主要结局
Time to First Relapse of Takayasu Arteritis (TAK) From Baseline through End of the Double-Blind (DB) Period
时间窗: Up to occurrence of 40 events (approximately 52 months)
Relapse of TAK is defined as the presence of signs or symptoms as judged by the investigator for at least 2 of the following categories: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, or ischemic symptoms OR where the criteria are met based on one category per protocol definition of relapse of TAK.
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 58 months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
- Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline through End of the DB Period(Up to occurrence of 40 events (approximately 52 months))
- Time to Worsening of Imaging Assessment Due to Takayasu Arteritis (TAK) From Baseline through End of the DB Period(Up to occurrence of 40 events (approximately 52 months))