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Guselkumab 在瘘管、肛周克罗恩病参与者中的研究 (FUZION CD)

2026年11月2日 更新者：Janssen-Cilag Ltd.

一项 3 期、随机、安慰剂对照、平行组、多中心研究，以评估 Guselkumab 在瘘管、肛周克罗恩病参与者中的疗效和安全性

The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.

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)

288

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

  • 以色列
      • Afula、以色列、1834111
        • Haemek Medical Center
      • Haifa、以色列、31096
        • Rambam Medical Center
      • Jerusalem、以色列、9103102
        • Shaare Zedek Medical Center
      • Petah Tikva、以色列、49100
        • Rabin Medical Center Beilinson Campus
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 2X8
        • University of Alberta- Ziedler Ledcor Centre
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H2Y9
        • Nova Scotia Health Authority
    • Ontario
      • London、Ontario、加拿大、N6A 5A5
        • London Health Sciences Centre
      • Toronto、Ontario、加拿大、M5G 1X5
        • Mount Sinai Hospital
    • Quebec
      • Montreal、Quebec、加拿大、H3G 1A4
        • McGill University Health Centre
  • 匈牙利
      • Budapest、匈牙利、1062
        • Magyar Honvedseg Egeszsegugyi Kozpont
      • Budapest、匈牙利、1082
        • Semmelweis Egyetem
      • Budapest、匈牙利、1083
        • Semmelweis Egyetem 2
      • Budapest、匈牙利、H-1088
        • Semmelweis Egyetem 1
      • Pécs、匈牙利、7624
        • Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
      • Szeged、匈牙利、6725
        • Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp
  • 台湾
      • Changhua、台湾、500
        • Changhua Christian Hospital
      • Taichung、台湾、40705
        • Taichung Veterans General Hospital
      • Taipei、台湾、10002
        • National Taiwan University Hospital
      • Taoyuan City、台湾、333
        • Chang Gung Memorial Hospital Linkou Branch
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、06560
        • Gazi University Medical Faculty
      • Istanbul、土耳其（türkiye）、34098
        • Istanbul University Cerrahpasa Medical Faculty
      • Istanbul、土耳其（türkiye）、34734
        • Acibadem Kozyatagi Hospital
      • Izmir、土耳其（türkiye）、35100
        • Ege University Medical Faculty
      • Mersin、土耳其（türkiye）、33110
        • Mersin University Medical Faculty Hospital
  • 埃及
      • Alexandria、埃及、21131
        • Alexandria University Hospital
      • Alexandria、埃及、21131
        • Alexandria University Hospital 1
      • Cairo、埃及、11451
        • National Hepatology and Tropical Medicine Research Institute
      • Cairo、埃及、11517
        • Ain Shams University Hospital
      • Giza、埃及、12613
        • Cairo university
  • 希腊
      • Athens、希腊、10676
        • Evangelismos General Hospital of Athens
      • Athens、希腊、156 69
        • Sotiria General State Hospital of Chest Diseases
      • Athens、希腊、11528
        • Hippokration Hospital 1
      • Athens Attica、希腊、115 28
        • Alexandra General Hospital of Athens
      • Heraklion、希腊、71110
        • University Hospital of Heraklion
      • Larissa、希腊、41110
        • University Hospital Of Larissa
      • Pátrai、希腊、26504
        • Patras University Hospital
      • Thessaloniki、希腊、54642
        • Hippokration Hospital
  • 德国
      • Berlin、德国、10117
        • Charite - Campus Mitte
      • Frankfurt、德国、60590
        • JWG-University Hospital
      • Kiel、德国、24105
        • Universitatsklinikum Schleswig Holstein Kiel
      • Mannheim、德国、68167
        • Universitaetsklinikum Mannheim
      • Ulm、德国、89081
        • Universitaetsklinikum Ulm
  • 意大利
      • Milan、意大利、20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Negrar ( Ve)、意大利、37024
        • Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
      • Pisa、意大利、56124
        • Azienda Ospedaliera Universitaria Pisana
      • Rho、意大利
        • Azienda Ospedaliera G.Salvini Ospedale di Rho
      • Roma、意大利、00168
        • Policlinico Universitario Agostino Gemelli
      • Rozzano、意大利、20089
        • Istituto Clinico Humanitas
      • San Giovanni Rotondo、意大利、71013
        • Casa Sollievo della Sofferenza
  • 捷克语
      • Prague、捷克语、170 04
        • ISCARE a.s.
      • České Budějovice、捷克语、37001
        • Nemocnice Ceske Budejovice a s
  • 日本
      • Abiko、日本、270-1168
        • KOKIKAI Tokatsu Tsujinaka Hospital
      • Chikushino-shi、日本、818-8502
        • Fukuoka University Chikushi Hospital
      • Fukuoka、日本、814 0180
        • Fukuoka University Hospital
      • Fukuoka、日本、807-8555
        • Hospital of the University of Occupational and Environmental Health
      • Fukuoka-ken、日本、802-0077
        • Kitakyushu Municipal Medical Center
      • Hiroshima、日本、734 8551
        • Hiroshima University Hospital
      • Kagoshima、日本、892-0846
        • Sameshima Hospital
      • Kashihara、日本、634-8521
        • Nara Medical University Hospital
      • Kashiwa、日本、277-0871
        • Tsujinaka Hospital Kashiwanoha
      • Nagasaki、日本、852-8501
        • Nagasaki University Hospital
      • Nagoya、日本、457-8511
        • Kojunkai Daido Clinic
      • Nagoya、日本、466 8560
        • Nagoya University Hospital
      • Nishinomiya、日本、663-8501
        • The Hospital of Hyogo College of Medicine
      • Okayama、日本、700 8558
        • Okayama University Hospital
      • Osaka、日本、530-0011
        • Kinshukai Infusion Clinic
      • Sakai、日本、591-8025
        • JOHAS Osaka Rosai Hospital
      • Sapporo、日本、065-0033
        • Sapporo Higashi Tokushukai Hospital
      • Shinjuku-ku、日本、169-0073
        • Tokyo Yamate Medical Center
      • Shizuoka、日本、432-8061
        • Matsuda Hospital
      • Suita、日本、565 0871
        • Osaka University Hospital
      • Tokyo、日本、181 8611
        • Kyorin University Hospital
      • Toyota、日本、470-1219
        • Ieda Hospital
      • Tsu、日本、514 8507
        • Mie University Hospital
      • Yokkaichi、日本、510-0016
        • Yokkaichi Hazu Medical Center
      • Yokohama、日本、221 0855
        • Yokohama Municipal Citizen's Hospital
  • 比利时
      • Brussels、比利时、1070
        • Hopital Erasme
      • Genk、比利时、3600
        • Ziekenhuis Oost-Limburg
      • Leuven、比利时、3000
        • UZ Leuven
      • Liège、比利时、B-4000
        • CHU Sart Tilman
  • 沙特阿拉伯
      • Dammam、沙特阿拉伯、31444
        • King Fahad Specialist hospital
      • Jeddah、沙特阿拉伯、21423
        • King Abdulaziz Medical City
      • Riyadh、沙特阿拉伯、12713
        • King Faisal Specialist Hospital & Research Center
      • Riyadh、沙特阿拉伯、11472
        • King Saud University Medical City
  • 法国
      • Neuilly-sur-Seine、法国、92200
        • Clinique Ambroise Pare
      • Nice、法国、06202
        • CHU de Nice Hopital de l Archet
      • Paris、法国、75014
        • Hopital Saint Joseph
      • Pierre-Bénite、法国、69495
        • Centre Hospitalier Lyon Sud
      • Rennes、法国、35033
        • CHRU Hopital de Pontchaillou
      • Vandœuvre-lès-Nancy、法国、54511
        • CHRU Nancy Brabois
  • 波兰
      • Bialystok、波兰、15-322
        • Gastromed Kralisz Romatowski Stachurska Sp. j.
      • Krakow、波兰、31-513
        • Centrum Medyczne Promed
      • Lodz、波兰、91 034
        • Centrum Medyczne Med Gastr
      • Rzeszów、波兰、35-326
        • Centrum Medyczne Medyk
      • Szczecin、波兰、71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Torun、波兰、87 100
        • GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
      • Warsaw、波兰、00-728
        • WIP Warsaw IBD Point Profesor Kierkus
      • Wroclaw、波兰、52-416
        • Centrum Medyczne Oporow
      • Wroclaw、波兰、50-449
        • Melita Medical Sp. z o.o.
  • 澳大利亚
      • Adelaide、澳大利亚、5042
        • Flinders Medical Centre
      • Fitzroy、澳大利亚、3065
        • St Vincent's Hospital - Melbourne
      • Liverpool、澳大利亚、2170
        • Liverpool Hospital
      • Murdoch、澳大利亚、6150
        • Fiona Stanley Hospital
      • Newtown、澳大利亚、2042
        • Royal Prince Alfred Hospital
      • North Terrace、澳大利亚、5000
        • Royal Adelaide Hospital
      • Parkville、澳大利亚、3050
        • Royal Melbourne Hospital
      • Perth、澳大利亚、6000
        • Royal Perth Hospital
      • South Brisbane、澳大利亚、4101
        • Mater Hospital
  • 约旦
      • Amman、约旦、11942
        • Jordan University Hospital
      • Amman、约旦
        • Abdali Hospital
      • Amman、约旦、11194
        • The Speciality Hospital (TSH) / Advanced Clinical Center
      • Irbid、约旦、22110
        • King Abdullah University Hospital
      • Irbid、约旦、21110
        • Irbid Specialty Hospital
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • University of Alabama at Birmingham
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • Yale University
    • Florida
      • Miami、Florida、美国、33136
        • University of Miami
      • Naples、Florida、美国、34102
        • Gastroenterology Group Of Naples
      • Orlando、Florida、美国、32804
        • AdventHealth Medical Group Blood & Marrow Transplant at Orlando
    • Kansas
      • Kansas City、Kansas、美国、66160
        • Kansas University Medical Center
    • Kentucky
      • Lexington、Kentucky、美国、40536
        • University of Kentucky Chandler Medical Center
      • Louisville、Kentucky、美国、40202
        • University of Louisville
    • Missouri
      • St Louis、Missouri、美国、63110
        • Washington University School Of Medicine
    • New York
      • New York、New York、美国、10029
        • Mount Sinai School of Medicine
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73112
        • Digestive Disease Specialists Inc
    • Tennessee
      • Germantown、Tennessee、美国、38138
        • Gastro One
      • Nashville、Tennessee、美国、37212
        • Vanderbilt University Medical Center
    • Texas
      • Tyler、Texas、美国、75701
        • Tyler Research Institute, LLC
    • Washington
      • Seattle、Washington、美国、98122
        • Swedish Medical Center
  • 英国
      • Hull、英国、HU3 2JZ
        • Hull University Teaching Hospitals NHS Trust
      • London、英国、SW17 0QT
        • St Georges University Hospital NHS Foundation Trust
      • London、英国、SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • London、英国、HA1 3UJ
        • London North West University Healthcare NHS Trust
      • Newcastle upon Tyne、英国、NE3 3HD
        • Newcastle upon Tyne Hospitals NHS Foundation Trust
      • Salford、英国、M6 8HD
        • Pennine Acute Hospitals NHS Trust
  • 荷兰
      • Amsterdam、荷兰、1105 AZ
        • Academisch Medisch Centrum Universiteit van Amsterdam
      • Nijmegen、荷兰、6525 GA
        • Radboudumc
      • Rotterdam、荷兰、3015 CE
        • Erasmus MC
      • Utrecht、荷兰、3584 CX
        • UMC Utrecht
  • 葡萄牙
      • Braga、葡萄牙、4710-243
        • Uls Braga - Hosp. Braga
      • Lisbon、葡萄牙、G1R 2J6
        • Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
      • Porto、葡萄牙、4099-001
        • H. Santo António - Centro Hospitalar do Porto
  • 西班牙
      • Barcelona、西班牙、08036
        • Hosp Clinic de Barcelona
      • Ferrol、西班牙、15405
        • Hosp. Arquitecto Marcide
      • Girona、西班牙、17007
        • Hosp. Univ. Dr. Josep Trueta
      • Madrid、西班牙、28006
        • Hosp. Univ. de La Princesa
      • Majadahonda、西班牙、28222
        • Hosp. Univ. Pta. de Hierro Majadahonda
      • Seville、西班牙、41009
        • Hosp. Virgen Macarena
      • Vigo、西班牙、36312
        • Hosp. Alvaro Cunqueiro
      • Zaragoza、西班牙、50009
        • Hosp. Univ. Miguel Servet
  • 韩国
      • Busan、韩国、48108
        • Inje University Haeundae Paik Hospital
      • Daegu、韩国、42415
        • Yeungnam University Hospital
      • Gyeonggi-do、韩国、13620
        • Seoul National University Bundang Hospital
      • Seoul、韩国、03080
        • Seoul National University Hospital
      • Seoul、韩国、06273
        • Gangnam Severance Hospital, Yonsei University Health System

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months
  • Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results
  • Has previously demonstrated lack of initial response (that is primary non-responders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes of advanced drug therapies at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents) or JAK inhibitors licensed for Crohn's disease treatment (that is, upadacitinib)

Exclusion Criteria:

  • Has a very severe luminal disease activity
  • History of concurrent rectovaginal fistulas (other types of concurrent fistula should be confirmed with the sponsor), rectal and/or anal stenosis, stoma or functioning ostomy (include all current stoma types abscess or collections which are not properly drained) colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus
  • Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation
  • Any medical contraindications preventing study participation
  • Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease

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：Group 1: Guselkumab

Participants will receive guselkumab Dose 1 intravenous (IV) infusion followed by Dose 2 subcutaneously (SC). Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) period and continue to receive guselkumab.
药品：Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

其他名称：
  • CNTO1959
药品：Placebo

Matching placebo will be administered subcutaneously/IV infusion.
实验性的：Group 2: Guselkumab

Participants will receive guselkumab Dose 1 IV infusion followed by Dose 3 SC. Participants will receive matching placebo to maintain the blind. At Week 24, guselkumab Dose 3 SC non-responders will switch to receive guselkumab dose 2 SC. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.
药品：Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

其他名称：
  • CNTO1959
药品：Placebo

Matching placebo will be administered subcutaneously/IV infusion.
实验性的：Group 3: Placebo

Participants will receive placebo IV infusion followed by placebo SC. At Week 24, placebo non-responders will continue to receive guselkumab Dose 4 followed by guselkumab Dose 2 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.
药品：Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

其他名称：
  • CNTO1959
药品：Placebo

Matching placebo will be administered subcutaneously/IV infusion.

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 who Achieve Combined Fistula Remission at Week 24
大体时间：Week 24

Percentage of participants who achieve combined fistula remission at Week 24 will be reported. Combined fistula remission is defined as 100 percentage (%) closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings [occurring spontaneously or after gentle finger compression] and absence of collections greater than (>) 2 centimeters (cm) of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the magnetic resonance imaging [MRI] results.
Week 24

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants who Achieve Combined Fistula Remission at Week 48
大体时间：Week 48

Percentage of participants who achieve combined fistula remission at Week 48 will be reported.
Week 48
Percentage of Participants who Achieve Clinically Assessed Fistula Remission
大体时间：Week 24

Percentage of participants who achieve clinically assessed fistula remission will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
Week 24
Percentage of Participants who Achieve Radiological Fistula Remission Based on Radiological Findings Assessed by MRI
大体时间：Week 24

Percentage of participants who achieve radiological fistula remission based on radiological findings assessed by MRI will be reported. Radiological remission is defined as absence of collections >2 cm of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the MRI results.
Week 24
Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 24
大体时间：Week 24

Percentage of participants who achieve clinically assessed fistula response at Week 24 will be reported. Clinically assessed fistula response is defined as a greater than or equal to (>=) 50% reduction from baseline in number of open or draining perianal fistulas.
Week 24
Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 12
大体时间：Week 12

Percentage of participants who achieve clinically assessed fistula response at Week 12 will be reported. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas.
Week 12
Change from Baseline in Crohn's Disease Activity Index (CDAI) by Visit Over Time Through Week 48
大体时间：Baseline up to Week 48

Change from baseline in CDAI by visit over time will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain (AP)/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being with scores ranging from 0 to approximately 600. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on a daily basis.
Baseline up to Week 48
Percentage of Participants who Achieve Clinical Remission (CDAI less than [<] 150) by Visit Over Time Through Week 48 Among Participants with CDAI Greater than (>) 150 at Baseline
大体时间：Through Week 48

Percentage of participants who achieve clinical remission (CDAI <150) by visit over time through Week 48 among participants with CDAI >150 at baseline will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain [AP]/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being with scores ranging from 0 to approximately 600. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on a daily basis.
Through Week 48
Percentage of Participants who Achieve a Clinical Response by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline
大体时间：Through Week 48

Percentage of participants who achieve a clinical response by visit over time through Week 48 among participants with CDAI >150 at baseline will be reported. Clinical response is defined greater than or equal to (>=) 100-point reduction from baseline in CDAI, or CDAI <150.
Through Week 48
Percentage of Participants who Achieve Steroid-free Clinical Remission by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline
大体时间：Through Week 48

Percentage of participants who achieve steroid-free clinical remission by visit over time through Week 48 among participants with CDAI >150 at baseline will be reported. Steroid-free clinical remission is defined as CDAI <150 and not receiving corticosteroids by visit over time through Week 48 among participants with CDAI >150 at baseline.
Through Week 48
Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response Among Participants With CDAI >220 at Baseline
大体时间：Week 24 and Week 48

Percentage of participants who achieve combined clinical response and clinically assessed fistula response among participants with CDAI >220 at baseline at baseline will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas.
Week 24 and Week 48
Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline
大体时间：Week 24 and Week 48

Percentage of participants who achieve combined clinical remission and clinically assessed fistula remission among participants with CDAI >220 at baseline at will be reported. Clinical remission is defined as CDAI <150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
Week 24 and Week 48
Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline
大体时间：Week 24 and Week 48

Percentage of participants who achieve combined clinical response and clinically assessed fistula remission among participants with CDAI >220 at baseline will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
Week 24 and Week 48
Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response among Participants with CDAI >220 at Baseline
大体时间：Week 24 and Week 48

Percentage of participants who achieve combined clinical remission and clinically assessed fistula response among participants with CDAI >220 at baseline will be reported. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas.
Week 24 and Week 48
Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response at Week 24 and Week 48
大体时间：Week 24 and Week 48

Percentage of participants who achieve combined clinical response and clinically assessed fistula response at Week 24 and Week 48 will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas.
Week 24 and Week 48
Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission at Week 24 and Week 48
大体时间：Week 24 and Week 48

Percentage of participants who achieve combined clinical response and clinically assessed fistula remission at Week 24 and Week 48 will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
Week 24 and Week 48
Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response at Week 24 and Week 48
大体时间：Week 24 and Week 48

Percentage of participants who achieve combined clinical remission and clinically assessed fistula response at Week 24 and Week 48 will be reported. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas.
Week 24 and Week 48
Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission at Week 24 and Week 48
大体时间：Week 24 and Week 48

Percentage of participants who achieve combined clinical remission and clinically assessed fistula remission will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
Week 24 and Week 48
Change from Baseline in Perianal Disease Activity Index (PDAI) Overall Score, Discharge Score, and Pain Score by Visit Over Time Through Week 48
大体时间：Baseline up to Week 48

Change from baseline in PDAI overall score, discharge score, and pain score by visit over time through Week 48 will be reported. The PDAI is a scoring system to evaluate the severity of perianal lesion associated with Crohn's disease. It includes the following 5 items: (a) Discharge; (0=no discharge to 4= Gross fecal soiling) (b) Pain; (0=no activity to 4= severe pain, severe limitation) (c) Restriction of sexual activity;(0=no perianal disease/skin tags to 4= unable to engage in sexual activity) (d) Type of perianal disease; (0=no perianal disease/skin tags to 4=Anal sphincter ulceration or fistulae with significant undermining ok skin) and (e) Degree of induration; (0=no induration to 4=gross fluctuance/abscess. Higher scores indicate more severe or active disease.
Baseline up to Week 48
Percentage of Participants who Achieve Clinically Assessed Fistula Response by Visit Over Time Through Week 48
大体时间：Through Week 48

Percentage of participants with clinically assessed fistula response by visit over time through Week 48 will be reported. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas.
Through Week 48
Percentage of Participants who Achieve Clinically Assessed Fistula Remission by Visit over Time Through Week 48
大体时间：Through Week 48

Percentage of participants with clinically assessed fistula remission by visit over through Week 48 time will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
Through Week 48
Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among the Participants who Achieve Clinical Fistula Remission at Week 24
大体时间：Week 48

Percentage of participants who achieve clinically assessed fistula remission at Week 48 among the participants who achieve clinical fistula remission at Week 24 will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
Week 48
Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among Those who Achieve Fistula Remission or Response at Week 24
大体时间：Week 48

Percentage of participants achieving clinically assessed fistula remission at Week 48 among those who achieve fistula remission or response (defined either by clinical or radiological assessment) at Week 24 will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
Week 48
Time to Clinical Fistula Remission
大体时间：Up to Week 96

Time to clinical fistula remission will be reported. Clinical fistula remission is defined as 100% closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings (occurring spontaneously or after gentle finger compression).
Up to Week 96
Percentage of Participants who Achieve Radiological Fistula Predominantly Fibrotic Status for all Existent Fistulas Assessed by MRI at Week 24 and Week 48
大体时间：Week 24 and Week 48

Percentage of participants who achieve radiological fistula predominantly fibrotic status for all existent fistulas assessed by MRI at Week 24 and Week 48 will be reported.
Week 24 and Week 48
Percentage of participants who Achieve Radiological Remission Based on Radiological Findings Assessed by MRI at Week 48
大体时间：Week 48

Percentage of participants with radiological remission based on radiological findings assessed by MRI at Week 48 will be reported. Radiological remission is defined as absence of collections >2 cm of the perianal fistulas, confirmed by a blinded central review of the MRI results.
Week 48
Percentage of Participants who Achieve Radiological Remission Assessed by MRI at Week 48 Among the Participants who Achieve Radiological Remission at Week 24
大体时间：Week 48

Percentage of participants who achieve radiological remission assessed by MRI at Week 48 among the participants who achieve radiological remission at Week 24 will be reported. Radiological remission is defined as absence of collections >2 cm of the perianal fistulas, confirmed by a blinded central review of the MRI results.
Week 48
Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission at Week 48 Among the Participants who Achieve Combined Clinical and Radiological Fistula Remission at Week 24
大体时间：Week 48

Percentage of participants who achieve combined clinically assessed and radiological (assessed by MRI) fistula remission at Week 48 among the participants who achieve combined clinical and radiological fistula remission at Week 24.
Week 48
Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission at Week 48 Among the Participants with Clinical Fistula Response at Week 24
大体时间：Week 48

Percentage of participants who achieve combined clinically assessed and radiological (assessed by MRI) fistula remission at Week 48 among the participants who achieve clinical fistula response at Week 24 will be reported.
Week 48
Percentage of Participants with Proctitis at Week 48 Among Participants with MRI-confirmed Proctitis at Baseline
大体时间：Week 48

Percentage of participants with proctitis at Week 48 among participants with MRI-confirmed proctitis at baseline will be reported. Proctitis is defined as the inflammation of the lining of the rectum.
Week 48
Change from Baseline in Magnetic Resonance Novel Index for Fistula imaging in Crohn's disease (MAGNIFI-CD) by Visit Over Time Through Week 48
大体时间：Baseline up to Week 48

Change from baseline in MAGNIFI-CD by visit over time through Week 48 will be reported. The MAGNIFI-CD is based on MRI assessment of 6 items including number of fistula tracts, fistula length, hyperintensity of primary tract on post-contrast T1-weighted images, dominant feature, extension, and inflammatory mass. The total MAGNIFI-CD score ranges from 0 (no disease activity) to 25 (severe disease activity). It assesses the MRI data and determines perianal fistulizing CD activity with improved operating characteristics compared to the Van Assche Index (VAI) and the modified VAI (mVAI).
Baseline up to Week 48
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by Visit Over Time Through Week 48
大体时间：Baseline up to Week 48

Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by visit over time through Week 48 will be reported. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD to evaluate patient reported outcomes (PROs) across 4 dimensions: bowel symptoms (loose stools, AP), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Baseline up to Week 48
Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score by Visit Over Time Through Week 48
大体时间：Baseline; Up to Week 48

Change From baseline in FACIT-F Score at Week 48 will be reported. The FACIT-F is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists of 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score is calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Baseline; Up to Week 48
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Crohn's Disease (WPAI:CD) by Visit Over Time Through Week 48
大体时间：Baseline; Up to Week 48

Change from baseline in WPAI:CD by visit over time through Week 48 will be reported. The WPAI:CD assesses the impact of CD on work and activity during the past 7 days. The specificity of WPAI:CD is achieved by replacing "health problems" in the general health version of the WPAI with "CD." It consists of 6 questions, which elicit the following information: employment status; hours missed due to CD; hours missed due to other reasons; hours actually worked; the degree to which CD affected productivity while working from 0 (no effect) to 10 (maximum impairment); and the degree to which CD affected regular activities (from 0-10). The sum of worktime missed and impairment at work yields the overall work impairment (productivity loss) score; scores are expressed as percent of impairment/productivity loss, with higher scores indicating greater impairment.
Baseline; Up to Week 48
Change from Baseline in Quality-of-life as Assessed by European Quality-of-Life Five Dimension Five Level Scale (EQ5D-5L) Score by Visit Over Time Through Week 48
大体时间：Baseline up to Week 48

Change from baseline in quality-of-life (EQ5D-5L) score by visit over time through Week 48 will be reported. The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Baseline up to Week 48
Change from Baseline in the Jorge-Wexner Score by Visit Over Time Through Week 48
大体时间：Baseline; Through Week 48

Change from baseline in the Jorge-Wexner score by visit over time through Week 48 will be reported. The Jorge-Wexner scoring system cross-tabulates frequencies and different anal incontinence presentations.
Baseline; Through Week 48
Change from Baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by Visit Over Time Through Week 48
大体时间：Baseline; Through Week 48

Change from baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by visit over time through Week 48 will be reported. The IBD-DI consists of 28 items that evaluate the 5 domains of overall health, body function, body structures, activity participation and environmental factors. Each item response is graded from 0 to 4 for each area evaluated (0 = very good; 1 = Good; 2 = medium; 3 = Bad; 4 = Very bad). The final composite score representative of the overall degree of disability ranging from -80 (maximum degree of disability) to 22 (no disability).
Baseline; Through Week 48
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
大体时间：Up to Week 48 and Week 96

An adverse event (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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Up to Week 48 and Week 96
Number of Participants with Treatment-emergent Serious Adverse Events (TESAEs)
大体时间：Up to Week 48 and Week 96

An serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TESAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state.
Up to Week 48 and Week 96

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-Cilag Ltd.

调查人员

  • 研究主任：Janssen-Cilag Ltd. Clinical Trial、Janssen-Cilag Ltd.

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)

2022年9月27日

初级完成 (估计的)

2027年3月25日

研究完成 (估计的)

2027年3月25日

研究注册日期

首次提交

2022年4月21日

首先提交符合 QC 标准的

2022年4月21日

首次发布 (实际的)

2022年4月26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

  • CR109189
  • 2021-000491-10 (EudraCT编号)
  • CNTO1959CRD3005 (其他标识符：Janssen Research & Development, LLC)
  • 2023-504740-33-00 (注册表标识符：EUCT number)
  • 2023 (美国 NIH 拨款/合同)

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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