A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 104
- 主要终点
- Percentage of Participants with Clinical Remission at Week 56
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.
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
- Double (Participant, 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
- •Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent for screening
- •A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
- •Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy
- •Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
- •Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids
排除标准
- •Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon
- •Presence of a stoma
- •Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
- •Have severe colitis or have evidence of Crohn's Disease (CD)
研究组 & 干预措施
Open-label Induction Phase: Guselkumab Intravenously (IV)
Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase.
干预措施: Guselkumab Intravenous (Drug)
Open-label Induction Phase: Guselkumab Subcutaneously (SC)
Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase.
干预措施: Guselkumab Subcutaneous (Drug)
Double-blind Maintenance Phase: Guselkumab 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 BW up to Week 56.
干预措施: Guselkumab Subcutaneous (Drug)
Double-blind Maintenance Phase: Guselkumab 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 BW up to Week 56.
干预措施: Guselkumab Subcutaneous (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 56.
干预措施: Guselkumab Subcutaneous (Drug)
结局指标
主要结局
Percentage of Participants with Clinical Remission at Week 56
时间窗: Week 56
Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
次要结局
- Percentage of Participants with Clinical Remission at Week 12(Week 12)
- Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12(Week 12)
- Percentage of Participants with Symptomatic Remission at Week 12(Week 12)
- Percentage of Participants with Symptomatic Remission at Week 56(Week 56)
- Number of Participants with Incidence of Anti-guselkumab Antibodies(Up to Week 68)
- Percentage of Participants with AEs Leading to Discontinuation of Study Intervention(Up to Week 68)
- Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56(Week 56)
- Percentage of Participants with Clinical Response at Week 12(Week 12)
- Percentage of Participants with Clinical Response at Week 56(Week 56)
- Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12(Week 56)
- European Union: Percentage of Participants with Endoscopic Healing at Week 12(Week 12)
- United States: Percentage of Participants With Endoscopic Improvement at Week 56(Week 56)
- European Union: Percentage of Participants With Endoscopic Healing at Week 56(Week 56)
- Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56(Week 56)
- Serum Concentration of Guselkumab During Induction Phase(From Week 0 to Week 12)
- United States: Percentage of Participants with Endoscopic Improvement at Week 12(Week 12)
- Percentage of Participants With PUCAI Remission at Week 56(Week 56)
- Percentage of Participants Who Achieve Endoscopic Normalization at Week 56(Week 56)
- Serum Concentration of Guselkumab During Maintenance Phase(From Week 12 to Week 56)
- Percentage of Participants with Adverse Events (AEs)(Up to Week 68)
- Percentage of Participants with Serious Adverse Events (SAEs)(Up to Week 68)