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瘻孔形成性肛門周囲クローン病の参加者におけるグセルクマブの研究 (FUZION CD)

2026年11月2日 更新者：Janssen-Cilag Ltd.

瘻孔形成性肛門周囲クローン病の参加者におけるグセルクマブの有効性と安全性を評価するための第 3 相無作為化プラセボ対照並行群間多施設研究

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

288

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ、35294
        • University of Alabama at Birmingham
    • Connecticut
      • New Haven、Connecticut、アメリカ、06510
        • Yale University
    • Florida
      • Miami、Florida、アメリカ、33136
        • University of Miami
      • Naples、Florida、アメリカ、34102
        • Gastroenterology Group Of Naples
      • Orlando、Florida、アメリカ、32804
        • AdventHealth Medical Group Blood & Marrow Transplant at Orlando
    • Kansas
      • Kansas City、Kansas、アメリカ、66160
        • Kansas University Medical Center
    • Kentucky
      • Lexington、Kentucky、アメリカ、40536
        • University of Kentucky Chandler Medical Center
      • Louisville、Kentucky、アメリカ、40202
        • University of Louisville
    • Missouri
      • St Louis、Missouri、アメリカ、63110
        • Washington University School Of Medicine
    • New York
      • New York、New York、アメリカ、10029
        • Mount Sinai School of Medicine
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ、73112
        • Digestive Disease Specialists Inc
    • Tennessee
      • Germantown、Tennessee、アメリカ、38138
        • Gastro One
      • Nashville、Tennessee、アメリカ、37212
        • Vanderbilt University Medical Center
    • Texas
      • Tyler、Texas、アメリカ、75701
        • Tyler Research Institute, LLC
    • Washington
      • Seattle、Washington、アメリカ、98122
        • Swedish Medical Center
  • イギリス
      • Hull、イギリス、HU3 2JZ
        • Hull University Teaching Hospitals NHS Trust
      • London、イギリス、SW17 0QT
        • St Georges University Hospital NHS Foundation Trust
      • London、イギリス、SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • London、イギリス、HA1 3UJ
        • London North West University Healthcare NHS Trust
      • Newcastle upon Tyne、イギリス、NE3 3HD
        • Newcastle upon Tyne Hospitals NHS Foundation Trust
      • Salford、イギリス、M6 8HD
        • Pennine Acute Hospitals NHS Trust
  • イスラエル
      • Afula、イスラエル、1834111
        • Haemek Medical Center
      • Haifa、イスラエル、31096
        • Rambam Medical Center
      • Jerusalem、イスラエル、9103102
        • Shaare Zedek Medical Center
      • Petah Tikva、イスラエル、49100
        • Rabin Medical Center Beilinson Campus
  • イタリア
      • Milan、イタリア、20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Negrar ( Ve)、イタリア、37024
        • Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
      • Pisa、イタリア、56124
        • Azienda Ospedaliera Universitaria Pisana
      • Rho、イタリア
        • Azienda Ospedaliera G.Salvini Ospedale di Rho
      • Roma、イタリア、00168
        • Policlinico Universitario Agostino Gemelli
      • Rozzano、イタリア、20089
        • Istituto Clinico Humanitas
      • San Giovanni Rotondo、イタリア、71013
        • Casa Sollievo della Sofferenza
  • エジプト
      • Alexandria、エジプト、21131
        • Alexandria University Hospital
      • Alexandria、エジプト、21131
        • Alexandria University Hospital 1
      • Cairo、エジプト、11451
        • National Hepatology and Tropical Medicine Research Institute
      • Cairo、エジプト、11517
        • Ain Shams University Hospital
      • Giza、エジプト、12613
        • Cairo university
  • オランダ
      • Amsterdam、オランダ、1105 AZ
        • Academisch Medisch Centrum Universiteit van Amsterdam
      • Nijmegen、オランダ、6525 GA
        • Radboudumc
      • Rotterdam、オランダ、3015 CE
        • Erasmus MC
      • Utrecht、オランダ、3584 CX
        • UMC Utrecht
  • オーストラリア
      • Adelaide、オーストラリア、5042
        • Flinders Medical Centre
      • Fitzroy、オーストラリア、3065
        • St Vincent's Hospital - Melbourne
      • Liverpool、オーストラリア、2170
        • Liverpool Hospital
      • Murdoch、オーストラリア、6150
        • Fiona Stanley Hospital
      • Newtown、オーストラリア、2042
        • Royal Prince Alfred Hospital
      • North Terrace、オーストラリア、5000
        • Royal Adelaide Hospital
      • Parkville、オーストラリア、3050
        • Royal Melbourne Hospital
      • Perth、オーストラリア、6000
        • Royal Perth Hospital
      • South Brisbane、オーストラリア、4101
        • Mater Hospital
  • カナダ
    • Alberta
      • Edmonton、Alberta、カナダ、T6G 2X8
        • University of Alberta- Ziedler Ledcor Centre
    • Nova Scotia
      • Halifax、Nova Scotia、カナダ、B3H2Y9
        • Nova Scotia Health Authority
    • Ontario
      • London、Ontario、カナダ、N6A 5A5
        • London Health Sciences Centre
      • Toronto、Ontario、カナダ、M5G 1X5
        • Mount Sinai Hospital
    • Quebec
      • Montreal、Quebec、カナダ、H3G 1A4
        • McGill University Health Centre
  • ギリシャ
      • Athens、ギリシャ、10676
        • Evangelismos General Hospital of Athens
      • Athens、ギリシャ、156 69
        • Sotiria General State Hospital of Chest Diseases
      • Athens、ギリシャ、11528
        • Hippokration Hospital 1
      • Athens Attica、ギリシャ、115 28
        • Alexandra General Hospital of Athens
      • Heraklion、ギリシャ、71110
        • University Hospital of Heraklion
      • Larissa、ギリシャ、41110
        • University Hospital Of Larissa
      • Pátrai、ギリシャ、26504
        • Patras University Hospital
      • Thessaloniki、ギリシャ、54642
        • Hippokration Hospital
  • サウジアラビア
      • Dammam、サウジアラビア、31444
        • King Fahad Specialist hospital
      • Jeddah、サウジアラビア、21423
        • King Abdulaziz Medical City
      • Riyadh、サウジアラビア、12713
        • King Faisal Specialist Hospital & Research Center
      • Riyadh、サウジアラビア、11472
        • King Saud University Medical City
  • スペイン
      • Barcelona、スペイン、08036
        • Hosp Clinic de Barcelona
      • Ferrol、スペイン、15405
        • Hosp. Arquitecto Marcide
      • Girona、スペイン、17007
        • Hosp. Univ. Dr. Josep Trueta
      • Madrid、スペイン、28006
        • Hosp. Univ. de La Princesa
      • Majadahonda、スペイン、28222
        • Hosp. Univ. Pta. de Hierro Majadahonda
      • Seville、スペイン、41009
        • Hosp. Virgen Macarena
      • Vigo、スペイン、36312
        • Hosp. Alvaro Cunqueiro
      • Zaragoza、スペイン、50009
        • Hosp. Univ. Miguel Servet
  • チェコ
      • Prague、チェコ、170 04
        • ISCARE a.s.
      • České Budějovice、チェコ、37001
        • Nemocnice Ceske Budejovice a s
  • トルコ（Türkiye）
      • Ankara、トルコ（Türkiye）、06560
        • Gazi University Medical Faculty
      • Istanbul、トルコ（Türkiye）、34098
        • Istanbul University Cerrahpasa Medical Faculty
      • Istanbul、トルコ（Türkiye）、34734
        • Acibadem Kozyatagi Hospital
      • Izmir、トルコ（Türkiye）、35100
        • Ege University Medical Faculty
      • Mersin、トルコ（Türkiye）、33110
        • Mersin University Medical Faculty Hospital
  • ドイツ
      • Berlin、ドイツ、10117
        • Charite - Campus Mitte
      • Frankfurt、ドイツ、60590
        • JWG-University Hospital
      • Kiel、ドイツ、24105
        • Universitatsklinikum Schleswig Holstein Kiel
      • Mannheim、ドイツ、68167
        • Universitaetsklinikum Mannheim
      • Ulm、ドイツ、89081
        • Universitaetsklinikum Ulm
  • ハンガリー
      • Budapest、ハンガリー、1062
        • Magyar Honvedseg Egeszsegugyi Kozpont
      • Budapest、ハンガリー、1082
        • Semmelweis Egyetem
      • Budapest、ハンガリー、1083
        • Semmelweis Egyetem 2
      • Budapest、ハンガリー、H-1088
        • Semmelweis Egyetem 1
      • Pécs、ハンガリー、7624
        • Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
      • Szeged、ハンガリー、6725
        • Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp
  • フランス
      • Neuilly-sur-Seine、フランス、92200
        • Clinique Ambroise Pare
      • Nice、フランス、06202
        • CHU de Nice Hopital de l Archet
      • Paris、フランス、75014
        • Hopital Saint Joseph
      • Pierre-Bénite、フランス、69495
        • Centre Hospitalier Lyon Sud
      • Rennes、フランス、35033
        • CHRU Hopital de Pontchaillou
      • Vandœuvre-lès-Nancy、フランス、54511
        • CHRU Nancy Brabois
  • ベルギー
      • Brussels、ベルギー、1070
        • Hopital Erasme
      • Genk、ベルギー、3600
        • Ziekenhuis Oost-Limburg
      • Leuven、ベルギー、3000
        • UZ Leuven
      • Liège、ベルギー、B-4000
        • CHU Sart Tilman
  • ポルトガル
      • Braga、ポルトガル、4710-243
        • Uls Braga - Hosp. Braga
      • Lisbon、ポルトガル、G1R 2J6
        • Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
      • Porto、ポルトガル、4099-001
        • H. Santo António - Centro Hospitalar do Porto
  • ポーランド
      • Bialystok、ポーランド、15-322
        • Gastromed Kralisz Romatowski Stachurska Sp. j.
      • Krakow、ポーランド、31-513
        • Centrum Medyczne Promed
      • Lodz、ポーランド、91 034
        • Centrum Medyczne Med Gastr
      • Rzeszów、ポーランド、35-326
        • Centrum Medyczne Medyk
      • Szczecin、ポーランド、71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Torun、ポーランド、87 100
        • GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
      • Warsaw、ポーランド、00-728
        • WIP Warsaw IBD Point Profesor Kierkus
      • Wroclaw、ポーランド、52-416
        • Centrum Medyczne Oporow
      • Wroclaw、ポーランド、50-449
        • Melita Medical Sp. z o.o.
  • ヨルダン
      • Amman、ヨルダン、11942
        • Jordan University Hospital
      • Amman、ヨルダン
        • Abdali Hospital
      • Amman、ヨルダン、11194
        • The Speciality Hospital (TSH) / Advanced Clinical Center
      • Irbid、ヨルダン、22110
        • King Abdullah University Hospital
      • Irbid、ヨルダン、21110
        • Irbid Specialty Hospital
  • 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
  • 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
  • 韓国
      • Busan、韓国、48108
        • Inje University Haeundae Paik Hospital
      • Daegu、韓国、42415
        • Yeungnam University Hospital
      • Gyeonggi-do、韓国、13620
        • Seoul National University Bundang Hospital
      • Seoul、韓国、03080
        • Seoul National University Hospital
      • Seoul、韓国、06273
        • Gangnam Severance Hospital, Yonsei University Health System

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

他の名前：
  • CNTO1959
薬：Placebo

Matching placebo will be administered subcutaneously/IV infusion.
実験的：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.
薬：Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

他の名前：
  • CNTO1959
薬：Placebo

Matching placebo will be administered subcutaneously/IV infusion.
実験的：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.
薬：Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

他の名前：
  • CNTO1959
薬：Placebo

Matching placebo will be administered subcutaneously/IV infusion.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants who Achieve Combined Fistula Remission at Week 24
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants who Achieve Combined Fistula Remission at Week 48
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Janssen-Cilag Ltd.

捜査官

  • スタディディレクター：Janssen-Cilag Ltd. Clinical Trial、Janssen-Cilag Ltd.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年9月27日

一次修了 (推定)

2027年3月25日

研究の完了 (推定)

2027年3月25日

試験登録日

最初に提出

2022年4月21日

QC基準を満たした最初の提出物

2022年4月21日

最初の投稿 (実際)

2022年4月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CR109189
  • 2021-000491-10 (EudraCT番号)
  • CNTO1959CRD3005 (その他の識別子：Janssen Research & Development, LLC)
  • 2023-504740-33-00 (レジストリ識別子：EUCT number)
  • 2023 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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