2023-504735-41-00招募中3 期
A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn’s Disease
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 31
- 主要终点
- Clinical remission at Week 52 (defined as PCDAI score ≤10)
研究概览
简要总结
To evaluate the efficacy and safety of guselkumab in pediatric participants with CD at the end of maintenance therapy among participants who were in clinical response to guselkumab at Week 12
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
- •Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index [PCDAI] score greater than [≥] 30)
- •Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (>=) 6 (or >=4 for participants with isolated ileal disease) during screening into this study
- •Participants must have a prior or current CD medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or intravenously (IV) corticosteroids or have received biologic therapy/JAK inhibitor for the treatment of CD and have a documented history of inadequate response, loss of response (LOR), or intolerance to the biologic therapy/JAK inhibitor
排除标准
- •Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery.
- •Participants must not have an abscess
- •Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline
结局指标
主要结局
Clinical remission at Week 52 (defined as PCDAI score ≤10)
Clinical remission at Week 52 (defined as PCDAI score ≤10)
Endoscopic response (≥50% reduction from SES-CD score at baseline) at Week 52
Endoscopic response (≥50% reduction from SES-CD score at baseline) at Week 52
次要结局
未报告次要终点
研究者
Clinical Registry Group
Scientific
Janssen - Cilag International
研究点 (31)
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