A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

288

Participants

Timeline

Start Date

September 27, 2022

Primary Completion Date

March 25, 2027

Study Completion Date

March 25, 2027

Conditions
Fistulizing Crohns DiseasePerianal Crohns Disease
Interventions
DRUG

Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

DRUG

Placebo

Matching placebo will be administered subcutaneously/IV infusion.

Trial Locations (153)

333

Chang Gung Memorial Hospital Linkou Branch, Taoyuan

500

Changhua Christian Hospital, Changhua

1062

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

1070

Hopital Erasme, Brussels

1082

Semmelweis Egyetem, Budapest

1083

Semmelweis Egyetem, Budapest

2042

Royal Prince Alfred Hospital, Newtown

2170

Liverpool Hospital, Liverpool

3000

UZ Leuven, Leuven

3050

Royal Melbourne Hospital, Parkville

3065

St Vincent's Hospital - Melbourne, Fitzroy

3600

Ziekenhuis Oost-Limburg, Genk

4101

Mater Hospital, South Brisbane

5000

Royal Adelaide Hospital, North Terrace

5042

Flinders Medical Centre, Adelaide

6000

Royal Perth Hospital, Perth

6150

Fiona Stanley Hospital, Murdoch

6725

Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp, Szeged

7624

Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika, Pécs

10002

National Taiwan University Hospital, Taipei

10029

Mount Sinai School of Medicine, New York

10117

Charite - Campus Mitte, Berlin

10676

Evangelismos General Hospital of Athens, Athens

11194

The Speciality Hospital (TSH) / Advanced Clinical Center, Amman

11451

National Hepatology and Tropical Medicine Research Institute, Cairo

11472

King Saud University Medical City, Riyadh

11517

Ain Shams University Hospital, Cairo

11528

Hippokration Hospital, Athens

11942

Jordan University Hospital, Amman

12613

Cairo university, Giza

12713

King Faisal Specialist Hospital & Research Center, Riyadh

13620

Seoul National University Bundang Hospital, Gyeonggi-do

15405

Hosp. Arquitecto Marcide, Ferrol

17007

Hosp. Univ. Dr. Josep Trueta, Girona

20089

Istituto Clinico Humanitas, Rozzano

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

21110

Irbid Specialty Hospital, Irbid

21131

Alexandria University Hospital, Alexandria

21423

King Abdulaziz Medical City, Jeddah

22110

King Abdullah University Hospital, Irbid

24105

Universitatsklinikum Schleswig Holstein Kiel, Kiel

26504

Patras University Hospital, Pátrai

28006

Hosp. Univ. de La Princesa, Madrid

28222

Hosp. Univ. Pta. de Hierro Majadahonda, Majadahonda

31096

Rambam Medical Center, Haifa

31444

King Fahad Specialist hospital, Dammam

32804

AdventHealth Medical Group Blood & Marrow Transplant at Orlando, Orlando

33110

Mersin University Medical Faculty Hospital, Mersin

33136

University of Miami, Miami

34098

Istanbul University Cerrahpasa Medical Faculty, Istanbul

34102

Gastroenterology Group Of Naples, Naples

34734

Acibadem Kozyatagi Hospital, Istanbul

35033

CHRU Hopital de Pontchaillou, Rennes

35100

Ege University Medical Faculty, Izmir

35294

University of Alabama at Birmingham, Birmingham

36312

Hosp. Alvaro Cunqueiro, Vigo

37001

Nemocnice Ceske Budejovice a s, České Budějovice

37024

Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar, Negrar ( Ve)

37212

Vanderbilt University Medical Center, Nashville

38138

Gastro One, Germantown

40202

University of Louisville, Louisville

40536

University of Kentucky Chandler Medical Center, Lexington

40705

Taichung Veterans General Hospital, Taichung

41009

Hosp. Virgen Macarena, Seville

41110

University Hospital Of Larissa, Larissa

42415

Yeungnam University Hospital, Daegu

48108

Inje University Haeundae Paik Hospital, Busan

50009

Hosp. Univ. Miguel Servet, Zaragoza

54511

CHRU Nancy Brabois, Vandœuvre-lès-Nancy

54642

Hippokration Hospital, Thessaloniki

56124

Azienda Ospedaliera Universitaria Pisana, Pisa

60590

JWG-University Hospital, Frankfurt

63110

Washington University School Of Medicine, St Louis

66160

Kansas University Medical Center, Kansas City

68167

Universitaetsklinikum Mannheim, Mannheim

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

71013

Casa Sollievo della Sofferenza, San Giovanni Rotondo

71110

University Hospital of Heraklion, Heraklion

73112

Digestive Disease Specialists Inc, Oklahoma City

75014

Hopital Saint Joseph, Paris

75701

Tyler Research Institute, LLC, Tyler

89081

Universitaetsklinikum Ulm, Ulm

92200

Clinique Ambroise Pare, Neuilly-sur-Seine

98122

Swedish Medical Center, Seattle

1834111

Haemek Medical Center, Afula

4941492

Rabin Medical Center Beilinson Campus, Petah Tikva

9103102

Shaare Zedek Medical Center, Jerusalem

06510

Yale University, New Haven

B-4000

CHU Sart Tilman, Liège

T6G 2X8

University of Alberta- Ziedler Ledcor Centre, Edmonton

B3H2Y9

Nova Scotia Health Authority, Halifax

N6A 5A5

London Health Sciences Centre, London

M5G 1X5

Mount Sinai Hospital, Toronto

H3G 1A4

McGill University Health Centre, Montreal

190 00

ISCARE a.s., Prague

06202

CHU de Nice Hopital de l Archet, Nice

156 69

Sotiria General State Hospital of Chest Diseases, Athens

115 28

Alexandra General Hospital of Athens, Athens Attica

H-1088

Semmelweis Egyetem, Budapest

Unknown

Azienda Ospedaliera G.Salvini Ospedale di Rho, Rho

Abdali Hospital, Amman

00168

Policlinico Universitario Agostino Gemelli, Roma

270-1168

KOKIKAI Tokatsu Tsujinaka Hospital, Abiko

818-8502

Fukuoka University Chikushi Hospital, Chikushino-shi

807-8555

Hospital of the University of Occupational and Enviromental Health, Fukuoka

814 0180

Fukuoka University Hospital, Fukuoka

802-0077

Kitakyushu Municipal Medical Center, Fukuoka-ken

734 8551

Hiroshima University Hospital, Hiroshima

892-0846

Sameshima Hospital, Kagoshima

634-8521

Nara Medical University Hospital, Kashihara

277-0871

Tsujinaka Hospital Kashiwanoha, Kashiwa

852-8501

Nagasaki University Hospital, Nagasaki

457-8511

Kojunkai Daido Clinic, Nagoya

466 8560

Nagoya University Hospital, Nagoya

663-8501

The Hospital of Hyogo College of Medicine, Nishinomiya

700 8558

Okayama University Hospital, Okayama

530-0011

Kinshukai Infusion Clinic, Osaka

591-8025

JOHAS Osaka Rosai Hospital, Sakai

065-0033

Sapporo Higashi Tokushukai Hospital, Sapporo

169-0073

Tokyo Yamate Medical Center, Shinjuku-ku

432-8061

Matsuda Hospital, Shizuoka

565 0871

Osaka University Hospital, Suita

181 8611

Kyorin University Hospital, Tokyo

470-1219

Ieda Hospital, Toyota

514 8507

Mie University Hospital, Tsu

510-0016

Yokkaichi Hazu Medical Center, Yokkaichi

221 0855

Yokohama Municipal Citizen's Hospital, Yokohama

1105 AZ

Academisch Medisch Centrum Universiteit van Amsterdam, Amsterdam

6525 GA

Radboudumc, Nijmegen

3015 GD

Erasmus MC, Rotterdam

3584 CX

UMC Utrecht, Utrecht

15-322

Gastromed Kralisz Romatowski Stachurska Sp. j., Bialystok

31-513

Centrum Medyczne Promed, Krakow

91 034

Centrum Medyczne Med Gastr, Lodz

35-326

Centrum Medyczne Medyk, Rzeszów

71-434

Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin

87 100

GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii, Torun

00-728

WIP Warsaw IBD Point Profesor Kierkus, Warsaw

50-449

Melita Medical Sp. z o.o., Wroclaw

52-416

Centrum Medyczne Oporow, Wroclaw

4710-243

Uls Braga - Hosp. Braga, Braga

G1R 2J6

Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos, Lisbon

4099-001

H. Santo António - Centro Hospitalar do Porto, Porto

03080

Seoul National University Hospital, Seoul

06273

Gangnam Severance Hospital, Yonsei University Health System, Seoul

08036

Hosp Clinic de Barcelona, Barcelona

06560

Gazi University Medical Faculty, Ankara

HU3 2JZ

Hull University Teaching Hospitals NHS Trust, Hull

HA1 3UJ

London North West University Healthcare NHS Trust, London

SE1 9RT

Guys and St Thomas NHS Foundation Trust, London

SW17 0QT

St Georges University Hospital NHS Foundation Trust, London

NE3 3HD

Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

M6 8HD

Pennine Acute Hospitals NHS Trust, Salford

All Listed Sponsors
lead

Janssen-Cilag Ltd.

INDUSTRY