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Een studie van Guselkumab bij deelnemers met fistelvorming, de ziekte van Perianale Crohn (FUZION CD)

2 november 2026 bijgewerkt door: Janssen-Cilag Ltd.

Een fase 3, gerandomiseerde, placebogecontroleerde, parallelle groep, multicenter studie om de werkzaamheid en veiligheid van Guselkumab te evalueren bij deelnemers met fistelvorming, perianale ziekte van Crohn

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

288

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

Andere namen:
  • CNTO1959
Geneesmiddel: Placebo

Matching placebo will be administered subcutaneously/IV infusion.
Experimenteel: 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.
Geneesmiddel: Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

Andere namen:
  • CNTO1959
Geneesmiddel: Placebo

Matching placebo will be administered subcutaneously/IV infusion.
Experimenteel: 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.
Geneesmiddel: Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

Andere namen:
  • CNTO1959
Geneesmiddel: Placebo

Matching placebo will be administered subcutaneously/IV infusion.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants who Achieve Combined Fistula Remission at Week 24
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants who Achieve Combined Fistula Remission at Week 48
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen-Cilag Ltd.

Onderzoekers

  • Studie directeur: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 september 2022

Primaire voltooiing (Geschat)

25 maart 2027

Studie voltooiing (Geschat)

25 maart 2027

Studieregistratiedata

Eerst ingediend

21 april 2022

Eerst ingediend dat voldeed aan de QC-criteria

21 april 2022

Eerst geplaatst (Werkelijk)

26 april 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CR109189
  • 2021-000491-10 (EudraCT-nummer)
  • CNTO1959CRD3005 (Andere identificatie: Janssen Research & Development, LLC)
  • 2023-504740-33-00 (Register-ID: EUCT number)
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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