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古塞奇尤单抗治疗中度至重度活动性溃疡性结肠炎儿童受试者的研究 (QUASAR Jr)

2026年11月2日 更新者：Janssen Research & Development, LLC

一项 3 期随机、开放标签诱导、双盲维持、平行组、多中心方案，用于评估 Guselkumab 在患有中度至重度活动性溃疡性结肠炎的儿科参与者中的疗效、安全性和药代动力学

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.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

112

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100191
        • Peking University Third Hospital
      • Beijing、中国、100020
        • Capital Center For Children's health Capital Medical University
      • Changzhou、中国、213004
        • Changzhou No 2 Peoples Hospital
      • Hangzhou、中国、310016
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Hangzhou、中国、310005
        • The Childrens Hospital Zhejiang University School Of Medicine
      • Shanghai、中国、200025
        • Ruijin Hospital Shanghai Jiao Tong University
      • Shenyang、中国、110055
        • Shengjing Hospital Of China Medical University
      • Zhengzhou、中国、450052
        • Henan Children's Hospital, Zhengzhou Children's Hospital
  • 丹麦
      • Aarhus N、丹麦、8200
        • Aarhus Universitetshospital
      • Hvidovre、丹麦、2650
        • Hvidovre Hospital
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、06560
        • Gazi University Medical Faculty
      • Ankara、土耳其（türkiye）、6620
        • Ankara University Medical Faculty
      • Istanbul、土耳其（türkiye）、34899
        • Marmara University Pendik Training Hospital
      • Istanbul、土耳其（türkiye）、34098
        • Istanbul University Cerrahpasa Medical Faculty
  • 意大利
      • Bergamo、意大利、24127
        • ASST Papa Giovanni XXIII Bergamo
      • Bologna、意大利、40133
        • Azienda USL di Bologna - Ospedale Maggiore
      • Florence、意大利、50139
        • AOU Meyer
      • Pescara、意大利、65124
        • Ospedale S. Spirito, Azienda Sanitaria Pescara
      • Roma、意大利、00161
        • AOU Policlinico Umberto I
      • Roma、意大利、00165
        • IRCCS Ospedale Pediatrico Bambino Gesu
      • San Giovanni Rotondo、意大利、71013
        • Casa Sollievo della Sofferenza
      • Trieste、意大利、34137
        • IRCCS Materno Infantile Burlo Garofolo
  • 挪威
      • Lørenskog、挪威、1478
        • Akershus Universitetssykehus
      • Oslo、挪威、0450
        • Oslo University Hospital
      • Tromsø、挪威、9030
        • Universitetssykehuset Nord-Norge HF
      • Trondheim、挪威、7030
        • St. Olavs Hospital
  • 日本
      • Fuchū、日本、183 8561
        • Tokyo Metropolitan Children's Medical Center
      • Kanazawa、日本、920 8641
        • Kanazawa University Hospital
      • Kobe、日本、650 0017
        • Kobe University Hospital
      • Kumamoto、日本、861 8520
        • Japanese Red Cross Kumamoto Hospital
      • Matsumoto、日本、390 8621
        • Shinshu University Hospital
      • Saga、日本、849-8501
        • Saga University Hospital
      • Setagaya Ku、日本、157 8535
        • National Center for Child Health and Development
      • Shinjuku、日本、160 0023
        • Tokyo Medical University Hospital
      • Takatsuki、日本、569-8686
        • Osaka Medical and Pharmaceutical University Hospital
      • Yokohama、日本、230-8765
        • Saiseikai Yokohamashi Tobu Hospital
  • 比利时
      • Charleroi、比利时、6042
        • CHU Charleroi Chimay
      • Ghent、比利时、9000
        • UZ Gent
      • Jette、比利时、1090
        • UZ Brussel
      • Leuven、比利时、3000
        • UZ Leuven
  • 法国
      • Bron、法国、69677
        • Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
      • Dijon、法国、21000
        • Hopital Francois Mitterand
      • Lille、法国、59037
        • CHRU Lille
      • Paris、法国、75019
        • APHP Hopital Robert Debre
      • Toulouse、法国、31059
        • CHU Toulouse
  • 波兰
      • Gdansk、波兰、80 803
        • Copernicus Podmiot Leczniczy Sp. z o.o
      • Rzeszów、波兰、35-302
        • Korczowski Bartosz Gabinet Lekarski
      • Warsaw、波兰、04 501
        • Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
      • Warsaw、波兰、04 730
        • Instytut Pomnik Centrum Zdrowia Dziecka
  • 澳大利亚
      • Nedlands、澳大利亚、6009
        • The Kids Research Institute Australia on behalf of the Centre for Child Health Research
      • South Brisbane、澳大利亚、4101
        • Mater Hospital Brisbane Inflammatory Bowel Diseases
      • Westmead、澳大利亚、2145
        • The Children's Hospital at Westmead
  • 美国
    • California
      • Oakland、California、美国、94609
        • Children's Hospital Oakland
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Riley Hospital for Children
    • New York
      • Lake Success、New York、美国、11042
        • NYU Langone Health
  • 葡萄牙
      • Lisbon、葡萄牙、1649-035
        • Uls Santa Maria - Hosp. Santa Maria
      • Porto、葡萄牙、4200 319
        • Uls Sao Joao - Hosp. Sao Joao
      • Porto、葡萄牙、4050-651
        • Uls Santo Antonio - Cmin
  • 西班牙
      • Madrid、西班牙、28009
        • Hosp. Infantil Univ. Nino Jesus
      • Sabadell、西班牙、08028
        • Corporacio Sanitari Parc Tauli
      • Valencia、西班牙、46026
        • Hosp. Univ. I Politecni La Fe

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：Guselkumab Intravenous

Guselkumab will be administered intravenously.

其他名称：
  • CNTO1959
  • TREMFYA
实验性的：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.
药品：Guselkumab Subcutaneous

Guselkumab will be administered subcutaneously.

其他名称：
  • CNTO1959
  • TREMFYA
实验性的：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.
药品：Guselkumab Subcutaneous

Guselkumab will be administered subcutaneously.

其他名称：
  • CNTO1959
  • TREMFYA
实验性的：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.
药品：Guselkumab Subcutaneous

Guselkumab will be administered subcutaneously.

其他名称：
  • CNTO1959
  • TREMFYA
实验性的：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.
药品：Guselkumab Subcutaneous

Guselkumab will be administered subcutaneously.

其他名称：
  • CNTO1959
  • TREMFYA

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants with Clinical Remission at Week 56
大体时间：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.
Week 56

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants with Clinical Response at Week 12
大体时间：Week 12

Percentage of participants with clinical response as assessed by modified Mayo score at Week 12 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1.
Week 12
Percentage of Participants with Clinical Remission at Week 12
大体时间：Week 12

Percentage of participants with clinical remission at Week 12 as assessed by modified Mayo score 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.
Week 12
Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12
大体时间：Week 12

Percentage of participants with PUCAI remission at Week 12 will be reported. It comprises 6 scales and ranges between 0 and 85 points. The scales are abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission.
Week 12
Percentage of Participants with Symptomatic Remission at Week 12
大体时间：Week 12

Percentage of participants with symptomatic remission at Week 12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
Week 12
United States: Percentage of Participants with Endoscopic Improvement at Week 12
大体时间：Week 12

Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
Week 12
European Union: Percentage of Participants with Endoscopic Healing at Week 12
大体时间：Week 12

Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
Week 12
Percentage of Participants with Clinical Response at Week 56
大体时间：Week 56

Percentage of participants with clinical response as assessed by modified Mayo score at Week 56 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by >= 30 percent and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1.
Week 56
Percentage of Participants With PUCAI Remission at Week 56
大体时间：Week 56

Percentage of participants with PUCAI remission at Week 56 will be reported. PUCAI comprises of 6 scales and ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission.
Week 56
Percentage of Participants with Symptomatic Remission at Week 56
大体时间：Week 56

Percentage of participants with symptomatic remission at Week 56 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
Week 56
Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12
大体时间：Week 56

Percentage of participants with symptomatic remission at Week 56 among participants who had symptomatic remission at Week 12 will be reported. Symptomatic remission score is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
Week 56
United States: Percentage of Participants With Endoscopic Improvement at Week 56
大体时间：Week 56

Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
Week 56
European Union: Percentage of Participants With Endoscopic Healing at Week 56
大体时间：Week 56

Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
Week 56
Percentage of Participants Who Achieve Endoscopic Normalization at Week 56
大体时间：Week 56

Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported.
Week 56
Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56
大体时间：Week 56

Percentage of participants histo-endoscopic mucosal healing per endoscopy subscore and histologic improvement at Week 56 will be reported. Histologic-endoscopic mucosal healing is defined as achieving a combination of histologic improvement and endoscopic improvement (US) or endoscopic healing (EU) (endoscopy subscore of 0 or 1).
Week 56
Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56
大体时间：Week 56

Percentage of participants with corticosteroid-free clinical remission at Week 56 will be reported. Corticosteroid free clinical remission is defined as a Mayo 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 (Week 0), and not receiving corticosteroids for at least 8 weeks prior to Week 56
Week 56
Serum Concentration of Guselkumab During Induction Phase
大体时间：From Week 0 to Week 12

Serum samples will be analyzed to determine concentrations of guselkumab overtime.
From Week 0 to Week 12
Serum Concentration of Guselkumab During Maintenance Phase
大体时间：From Week 12 to Week 56

Serum samples will be analyzed to determine concentrations of guselkumab over time.
From Week 12 to Week 56
Number of Participants with Incidence of Anti-guselkumab Antibodies
大体时间：Up to Week 68

Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed.
Up to Week 68
Percentage of Participants with Adverse Events (AEs)
大体时间：Up to Week 68

Percentage of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Up to Week 68
Percentage of Participants with Serious Adverse Events (SAEs)
大体时间：Up to Week 68

Percentage of participants with SAEs will be reported. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly.
Up to Week 68
Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
大体时间：Up to Week 68

Percentage of participants with AEs leading to discontinuation of study intervention will be reported.
Up to Week 68

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Janssen Research & Development, LLC

调查人员

  • 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月19日

初级完成 (估计的)

2027年2月10日

研究完成 (估计的)

2027年4月28日

研究注册日期

首次提交

2024年2月7日

首先提交符合 QC 标准的

2024年2月7日

首次发布 (实际的)

2024年2月15日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CR109251
  • 2022-001285-35 (EudraCT编号)
  • CNTO1959PUC3001 (其他标识符：Janssen Research & Development, LLC)
  • 2022-502238-22-00 (注册表标识符：EUCT number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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