Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 7
- 主要终点
- Percent of Patients Who Achieved PCDAI Response
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and pharmacokinetics are also evaluated.
详细描述
This is an open-label, uncontrolled, multicenter Phase 3 study conducted in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed as Crohn's disease at least 3 months prior to screening.
- •Have active Crohn's disease despite adequate conventional therapy.
排除标准
- •Patients with severe intestinal strictures (strictures which may affect the number of defecations, etc., or dilation of the colon or strictures in the proximal small bowel observed on barium radiograph, or strictures precluding the insertion of endoscope), a diagnosis of short bowel syndrome, or previous stoma surgery.
- •Patients who have a history of treatment with infliximab, or biological products (anti-TNFα agents and anti-IL-6 agents, etc.).
研究组 & 干预措施
TA-650
Responder criteria: Case where PCDAI score on the evaluation day was decreased by at least 15 points from that in the screening period and was ≤30.
Criteria for dose-increasing: When either of the following 2 items was satisfied after Week 14, the relevant patient would be considered to satisfy the criteria for dose increasing to 10 mg/kg.
- PCDAI score on the evaluation day was increased by at least 15 points compared to the lowest PCDAI score observed at Week 2, 6 or 10
- PCDAI score on the evaluation day exceeds 30
干预措施: TA-650 (Drug)
结局指标
主要结局
Percent of Patients Who Achieved PCDAI Response
时间窗: Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54
Crohn's Disease Activity Index(PCDAI) response was defined as a case where PCDAI on the evaluation day was decreased by at least 15 points compared to PCDAI in the screening period and decreased to not more than 30. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).
次要结局
- Percent of Patients Who Achieved PCDAI-Based Remission Rate.(Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54 and the last time point during the period from administration of the study drug to Week 54)
- PCDAI Score(Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54)
- Change From Baseline of PCDAI Score(Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54)
- Serum TA-650 Concentration(After dose of Week 0 to 54 or at the timing of discontinuation. On the blood sampling day, before administration of the study drug. Week 0, 22 and 46, before administration and one hour after the administration. Week 14, 30 and 38, before administration.)
- The Percent of the Patients Who Experienced an Adverse Event(Until the last time point during the period from administration of the study drug to Week 54)