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Исследование гуселькумаба у участников со свищами и перианальной болезнью Крона (FUZION CD)

2 ноября 2026 г. обновлено: Janssen-Cilag Ltd.

Фаза 3, рандомизированное, плацебо-контролируемое, многоцентровое исследование с параллельными группами для оценки эффективности и безопасности гуселькумаба у участников с фистулезом и перианальной болезнью Крона

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.

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

288

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Лекарство: Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

Другие имена:
  • CNTO1959
Лекарство: Placebo

Matching placebo will be administered subcutaneously/IV infusion.
Экспериментальный: 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.
Лекарство: Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

Другие имена:
  • CNTO1959
Лекарство: Placebo

Matching placebo will be administered subcutaneously/IV infusion.
Экспериментальный: 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.
Лекарство: Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

Другие имена:
  • CNTO1959
Лекарство: Placebo

Matching placebo will be administered subcutaneously/IV infusion.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants who Achieve Combined Fistula Remission at Week 24
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants who Achieve Combined Fistula Remission at Week 48
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Janssen-Cilag Ltd.

Следователи

  • Директор по исследованиям: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

27 сентября 2022 г.

Первичное завершение (Оцененный)

25 марта 2027 г.

Завершение исследования (Оцененный)

25 марта 2027 г.

Даты регистрации исследования

Первый отправленный

21 апреля 2022 г.

Впервые представлено, что соответствует критериям контроля качества

21 апреля 2022 г.

Первый опубликованный (Действительный)

26 апреля 2022 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

3 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 ноября 2026 г.

Последняя проверка

1 ноября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CR109189
  • 2021-000491-10 (Номер EudraCT)
  • CNTO1959CRD3005 (Другой идентификатор: Janssen Research & Development, LLC)
  • 2023-504740-33-00 (Идентификатор реестра: EUCT number)
  • 2023 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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