A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 137
- 主要终点
- Percentage of Participants with Clinical Remission at Week 52
研究概览
简要总结
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV corticosteroids, or biologic therapy/JAK inhibitor therapy; OR have a history of corticosteroid dependence; OR have a history of inadequate response to exclusive enteral nutrition (EEN)
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
研究组 & 干预措施
Open-label induction phase: Guselkumab Intravenously (IV)
Participants will receive guselkumab dose IV based on their body weight during the 12-week open-label induction phase.
干预措施: Guselkumab (Drug)
Double-blind Maintenance Phase: Guselkumab SC Dose Regimen 2
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their body weight up to Week 48.
干预措施: Guselkumab (Drug)
Open-label maintenance phase: Guselkumab SC
Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 48.
干预措施: Guselkumab (Drug)
Open-label induction phase: Guselkumab Subcutaneously (SC)
Participants will receive guselkumab dose SC based on their body weight during the 12-week open-label induction phase.
干预措施: Guselkumab (Drug)
Double-blind maintenance phase: Guselkumab SC Dose Regimen 1
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their body weight up to Week 48.
干预措施: Guselkumab (Drug)
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 (global) and greater than (\>) 50% reduction (U.S specific) from simplified endoscopic score-Crohn's Disease (SES-CD) score at baseline.
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 (global) and greater than (\>) 50% reduction (U.S specific) from simplified endoscopic score-Crohn's Disease (SES-CD) score at baseline.
次要结局
- 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 Clinical Remission at Week 12(Week 12)
- 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)
- Serum Concentration of Guselkumab During Induction Phase(From Week 0 to Week 12)
- Trough Plasma Concentration (Ctrough) of Guselkumab During Maintenance Phase(At Weeks 16, 24, 36, 48 and 52)
- Change from Baseline in Body Weight at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Change from Baseline in Body Weight Percentiles at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Change from Baseline in Body Weight z-scores at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Change from Baseline in Height at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Change from Baseline in Height Percentiles at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Change from Baseline in Height z-scores at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Change from Baseline in Height Velocity at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Percentage of Participants with Clinical Remission(Week 52)
- Percentage of Participants Who Achieve Endoscopic Response(Week 52)
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 64)
- Change from Baseline in Body Weight Percentiles at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Change from Baseline in Body Weight z-scores at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Change from Baseline in Height at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Change from Baseline in Height Percentiles at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Change from Baseline in Height z-scores at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Change from Baseline in Height Velocity at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- 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 Clinical Remission at Week 12(Week 12)
- 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)
- Serum Concentration of Guselkumab During Induction Phase(From Week 0 to Week 12)
- Trough Plasma Concentration (Ctrough) of Guselkumab During Maintenance Phase(At Weeks 16, 24, 36, 48 and 52)
- Change from Baseline in Body Weight at Weeks 12, 24, and 52(Baseline, Weeks 12, 24, and 52)
- Percentage of Participants with Clinical Remission(Week 52)
- Percentage of Participants Who Achieve Endoscopic Response(Week 52)