jRCT2071240040招募中不适用
[M14-671] A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib with Open-Label Induction, Randomized, Double-Blined Maintenance and Open-Label Long-Term Extension in Pediatric Subjects with Moderately to Severely Active Crohn's Disease 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: 待定最近更新:
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 with clinical remission per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 64
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
- •Weight at Screening and Baseline must be 10 kg
- •Moderate to severe CD defined as PCDAI > 30 and endoscopic evidence of mucosal inflammation as documented by a centrally read SES-CD of >/ 6 (or SES-CD of >/4 for isolated ileal disease) excluding the presence of narrowing component.
- •Documented diagnosis of CD prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy.
- •Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the investigator, must be available.
- •Demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, IMMs, and/or biologic therapy or in whom use of those therapies is medically contraindicated. For participants in the US, participants must have demonstrated an inadequate response, loss or response, or intolerance to one or more anti-TNFs (tumor necrosis factor).
排除标准
- •History of:
- •-A diagnosis of CD prior to 2 years of age.
- •-Currently known complications of CD such as:
- •-Active abscess (abdominal or perianal);
- •-Symptomatic bowel strictures;
- •-More than 2 missing segments of the following 5 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;
- •-Ostomy or ileoanal pouch;
- •-Surgical bowel resection within the past 3 months prior to Baseline, or a history of more than 3 bowel resections.
- •Japan participants only: positive result of beta-D-glucan or two consecutive indeterminate results of beta-D-glucan during the Screening period (screening for Pneumocystis jiroveci infection)
- •History of any of the following:
- •-Current diagnosis of UC, indeterminate colitis, or monogenic IBD;
- •-Fulminant colitis or toxic megacolon;
- •-Gastrointestinal perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment including history of volvulus and/or intussusception (telescoping of bowels);
- •Current diagnosis of any primary immune deficiency
- •Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded.
结局指标
主要结局
Percentage of participants with clinical remission per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 64
时间窗: Week 64
Percentage of participants with clinical remission per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 64 in the participants who achieved clinical response per PCDAI at Week 12
Achievement of endoscopic response at Week 64
时间窗: Week 64
Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12
Number of Participants with Adverse Events
Number of Participants with Adverse Events
次要结局
未报告次要终点
研究者
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