jRCT2011230031招募中不适用
[M14-658] A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib with Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy
AbbVie G.K.0 个研究点目标入组 110 人开始时间: 2023年12月4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
- 110
- 主要终点
- Percentage of Participants Achieving Adapted Mayo score (AMS) Clinical Remission (Period 1) at Week 8
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
- 2age old over 至 17age old under（—）
- 性别
- All
入选标准
- •Active UC with an AMS of 5 to 9 points and endoscopic subscore of 2 to
- •Demonstrate an inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.
排除标准
- •Partcipants with previous exposure to JAK inhibitors (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
- •Females who are pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.
结局指标
主要结局
Percentage of Participants Achieving Adapted Mayo score (AMS) Clinical Remission (Period 1) at Week 8
时间窗: Week 8
Percentage of Participants Achieving Adapted Mayo score (AMS) Clinical Remission
Percentage of Participants Achieving AMS Clinical Remission Among Week 8 Responders per AMS (Period 1) at Week 52
时间窗: Week 52
Percentage of Participants Achieving AMS Clinical Remission Among Week 8 Responders per AMS
次要结局
- Percentage of Participants Achieving AMS Clinical Response (Period 1) at Week 8(Week 8)
- Percentage of Participants Achieving Endoscopic Improvement (Period 1) at Week 8(Week 8)
- Percentage of Participants Achieving Partial Mayo Score (PMS) Clinical Remission (Period 1) at Week 8(Week 8)
- Percentage of Participants Achieving Endoscopic Improvement Among Week 8 Responders per AMS (Period 1) at Week 52(Week 52)
- Percentage of Participants Achieving PMS Clinical Response Among Week 8 Clinical Responders per AMS (Period 1) at Week 52(Week 52)
- Percentage of Participants Achieving PMS Clinical Remission Among Week 8 Responders per AMS (Period 1) at Week 52(Week 52)
- Percentage of Participants Achieving AMS Clinical Response Among Week 8 Responders per AMS (Period 1) at Week 52(Week 52)
- Percentage of Participants Achieving Corticosteroid-Free AMS Clinical Remission Among Week 8 Responders per AMS (Period 1) at Week 52(Week 52)
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