jRCT2031230352招募中不适用
A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease (MACARONI-23)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 主要终点
- Percentage of Participants with Clinical Remission at Week 52
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 18age old not（—）
- 性别
- All
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 or equal to [>=] 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) within 1 month of receiving study intervention at Week 0
- •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
Percentage of Participants with Clinical Remission at Week 52
时间窗: Week 52
Percentage of participants with clinical remission at Week 52 will be assessed. Clinical remission is defined as pediatric Crohn's Disease activity index (PCDAI) less than or equal to (<=) 10.
Percentage of Participants Who Achieve Endoscopic Response at Week 52
时间窗: Week 52
Percentage of participants who achieve endoscopic response at Week 52 will be assessed. Endoscopic response is defined as greater than or equal to (>=) 50 percent (%) reduction from simplified endoscopic score-Crohn's Disease (SES-CD) score at baseline.
次要结局
- Percentage of Participants with Clinical Remission at Week 12(Week 12)
- Percentage of Participants Who Achieve Endoscopic Response at Week 12(Week 12)
- Percentage of Participants with Clinical Response at Week 12(Week 12)
- Percentage of Participants with Clinical Response at Week 52(Week 52)
- Percentage of Participants with Endoscopic Remission at Week 52(Week 52)
- Percentage of Participants with Corticosteroid-free Remission at Week 52(Week 52)
- Percentage of Participants with Sustained Clinical Remission at Weeks 12, 24, and 52(Weeks 12, 24, and 52)
- Percentage of Participants with Clinical remission by Patient-Reported Outcome (PRO-2):Week 12 and/or Week 52(Week 12 and/or Week 52)
- Serum Concentration of Guselkumab During Induction Phase:From Week 0 to Week 12(Week 0 to Week 12)
- Trough Plasma Concentration (Ctrough) of Guselkumab During Maintenance Phase:At Weeks 16, 24, 36, 48 and 52(Weeks 16, 24, 36, 48 and 52)
- Change from Baseline in Body Weight Percentiles at Weeks 12, 24, and 52(Weeks 12, 24, and 52)
- Change from Baseline in Body Weight at Weeks 12, 24, and 52(Weeks 12, 24, and 52)
- Change from Baseline in Body Weight z-scores at Weeks 12, 24, and 52(Weeks 12, 24, and 52)
- Change from Baseline in Height at Weeks 12, 24, and 52(Weeks 12, 24, and 52)
- Change from Baseline in Height Percentiles at Weeks 12, 24, and 52(Weeks 12, 24, and 52)
- Change from Baseline in Height z-scores at Weeks 12, 24, and 52(Weeks 12, 24, and 52)
- Change from Baseline in Height Velocity at Weeks 12, 24, and 52(Weeks 12, 24, and 52)
- Percentage of Participants with Clinical Remission:Week 52(Week 52)
- Percentage of Participants Who Achieve Endoscopic Response:Week 52(Week 52)
研究者
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