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NCT07499232PHASE3Recruiting

A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Janssen Research & Development, LLC

Start Date

4/21/2026

Completion Date

12/11/2030

Summary

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion criteria: * Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy * Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 but less than or equal to (\<=) 450 * Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) \>= 4 (for participants with isolated ileal disease) or \>= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: 1. a minimum score of 1 for the component of "size of ulcers" AND 2. a minimum score of 1 for the component of "ulcerated surface" * In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study * Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol Exclusion criteria * Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab * Currently has or is suspected to have an abscess * Has an active fistula during screening or at Week 0 with an anticipated need for surgery * Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention * Currently has a malignancy or has a history of malignancy within 5 years before screening

Interventions

DRUG

Guselkumab

DRUG

Risankizumab

Interested in This Trial?

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Conditions

Crohn Disease

Locations

Digestive Health Specialists of the Southeast

Dothan, Alabama 36305

United States

East View Medical Research

Mobile, Alabama 36608

United States

Clinnova Research

Anaheim, California 92805

United States

United Gastroenterologists

Los Alamitos, California 90720

United States

TLC Clinical Research Inc

Los Angeles, California 90048

United States

Hoag Memorial Hospital

Newport Beach, California 92663

United States

Medical Associates Research Group, Inc.

San Diego, California 92123

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado 80907

United States

Medical Research Center of Connecticut

Hamden, Connecticut 06518

United States

Green Leaf Clinical Trials

Jacksonville, Florida 32258

United States

Sanchez Clinical Research, Inc

Miami, Florida 33157-6575

United States

Biodax Medical Research Trials

Miami, Florida 33186

United States

GI Pros Research

Naples, Florida 34102

United States

GCP Clinical Research

Tampa, Florida 33609

United States

Morehouse School of Medicine

Atlanta, Georgia 30310

United States

Gastroenterology Associates of Central GA

Macon, Georgia 31201

United States

Cotton-O'Neil Clinical Research Center

Topeka, Kansas 66606

United States

Gastroenterology Clinic of Acadiana

Lafayette, Louisiana 70503

United States

Michigan Center of Medical Research

Farmington Hills, Michigan 48334

United States

Westchester Putnam Gastroenterology

Carmel, New York 10512

United States

New York Gastroenterology Associates

New York, New York 10075

United States

Charlotte Gastroenterology and Hepatology, PLLC

Charlotte, North Carolina 28207

United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio 44060

United States

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma 73114

United States

Frontier Clinical Research

Uniontown, Pennsylvania 15401

United States

Palmetto Primary and Specialty Care Physicians, Charleston

Summerville, South Carolina 29486

United States

DFW Clinical Trials

Carrollton, Texas 75010

United States

Lubbock Gastroenterology

Lubbock, Texas 79424

United States

Gastroenterology Research of America, LLC

San Antonio, Texas 78229

United States

Southern Star Research Institute, LLC

San Antonio, Texas 78229

United States

The University of Texas Health Science Center at Tyler

Tyler, Texas 75708

United States

LKH-Univ. Klinikum Graz

Graz, 8036

Austria

Medizinische Universitatsklinik Innsbruck

Innsbruck, 6020

Austria

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, 5020

Austria

Krankenhaus der Barmherzigen Brüder

Vienna, 1020

Austria

Klinikum Wels Grieskirchen

Wels, 4600

Austria

Universitatsklinikum Wiener Neustadt

Wiener Neustadt, 2700

Austria

Cliniques Universitaires Saint Luc

Brussels, 1200

Belgium

Ziekenhuis Oost-Limburg

Genk, 3600

Belgium

Ghent University Hospital

Ghent, 9000

Belgium

Universitair Ziekenhuis Leuven

Leuven, 3000

Belgium

CHU de Liege

Liège, 4000

Belgium

Algemeen Ziekenhuis Delta

Roeselare, 8800

Belgium

GIRI Gastrointestinal Research Institute

Vancouver, British Columbia V6Z 2K5

Canada

Charlton Digestive Disease Centre

Hamilton, Ontario L8N1Y2

Canada

London Digestive Disease Institute

London, Ontario N6K 1M6

Canada

Taunton Surgical Centre

Oshawa, Ontario L1J 0C7

Canada

Toronto Immune and Digestive Health Institute Inc

Toronto, Ontario M6A 3B4

Canada

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec H2X 0C1

Canada

Clinique IMD

Montreal, Quebec H3H1E3

Canada

Changzhou No 2 Peoples Hospital

Changzhou, 213018

China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510261

China

The Sixth Affiliated Hospital Sun Yat sen University

Guangzhou, 510655

China

Zhongda Hospital Southeast University

Nanjing, 210009

China

Vojenska nemocnice Brno

Brno, 636 00

Czechia

Gastroenterologie, s.r.o., Hradec Kralove

Hradec Kralova, 500 02

Czechia

Hepato-gastroenterologie HK, s.r.o.

Hradec Králové, 500 12

Czechia

Fakultni Nemocnice Ostrava

Ostrava-Poruba, 708 00

Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 00

Czechia

Fakultni Thomayerova nemocnice

Prague, 14000

Czechia

Aarhus University Hospital

Aarhus C, 8200

Denmark

Sydvestjysk Sygehus

Esbjerg, 6700

Denmark

NAU New Aalborg University Hospital

Gistrup, 9260

Denmark

Herlev Hospital

Herlev, 2730

Denmark

Nordsjaellands Hospital, Hillerod

Hilleroed, 3400

Denmark

Hvidovre Hospital

Hvidovre, 2650

Denmark

Bispebjerg Hospital

København NV, 2400

Denmark

Odense UH og Svendberg sygehus

Odense C, 5000

Denmark

CHU Amiens Picardie

Amiens, 80000

France

Clermont Ferrand University Hospital

Clermont-Ferrand, 63000

France

Institut Prive MICI Clinique des Cedres

Échirolles, 38130

France

Aphm - Hopital Nord

Marseille, 13015

France

CHU Nantes - Hotel Dieu

Nantes, 44000

France

Clinique Ambroise Pare

Neuilly-sur-Seine, 92200

France

CHU Nimes

Nîmes, 30900

France

Aphp Hopital Saint Antoine

Paris, 75012

France

Hospices Civils de Lyon CHU Lyon Sud

Pierre-Bénite, 69495

France

CHU de Reims

Reims, 51100

France

Centre Hospitalier Universitaire de Nancy - Hôpital Central

Vandœuvre-lès-Nancy, 54511

France

GASTRO-Studien

Berlin, 10825

Germany

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, 12203

Germany

Universitatsklinikum Erlangen

Erlangen, 91054

Germany

Praxiszentrum Fur Gastroenterologie und Endoskopie Grevenbroich

Grevenbroich, 41515

Germany

Universitatsklinikum Jena

Jena, 07747

Germany

Universitatsklinikum Schleswig Holstein Kiel

Kiel, 24105

Germany

St. Marien und St. Annastiftskrankenhaus

Ludwigshafen am Rhein, 67067

Germany

Universitaetsklinikum Mannheim

Mannheim, 68167

Germany

Klinikum rechts der Isar der TU Munchen

München, 81675

Germany

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036

Hungary

Semmelweis Egyetem 1

Budapest, 1082

Hungary

Semmelweis Egyetem 2

Budapest, 1083

Hungary

Semmelweis Egyetem

Budapest, 1088

Hungary

Endomedix

Budapest, 1139

Hungary

Pannónia Magánorvosi Centrum Kft

Budapest, H-1136

Hungary

Clinexpert Gyongyos Kft

Gyöngyös, 3200

Hungary

Szegedi Tudomanyegyetem

Szeged, 6725

Hungary

A O U Sant Orsola Malpighi

Bologna, 40138

Italy

Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano

Bolzano, 39100

Italy

Azienda Ospedaliero Universitaria San Martino

Genova, 16132

Italy

IRCCS Ospedale San Raffaele

Milan, 20132

Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Ospedale Mauriziano Torino

Torino, 10128

Italy

Maastricht UMC

Maastricht, 6229 HX

Netherlands

Radboud Umcn

Nijmegen, 6525 GA

Netherlands

St. Elisabeth Ziekenhuis

Tilburg, 5022 GC

Netherlands

Centrum Medyczne Medis ManerMed Sp Z O O

Bydgoszcz, 85 229

Poland

Centrum Medyczne Plejady

Krakow, 30363

Poland

Centrum Medyczne Promed

Krakow, 31-513

Poland

Centrum Medyczne 'Medyk' Sp. z o.o. K.

Rzeszów, 35-326

Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434

Poland

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

Torun, 87 100

Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, 02-781

Poland

Medical Network Sp z o o

Warsaw, 04 501

Poland

FNsP F. D. Roosevelta Banska Bystrica

Banská Bystrica, 975 17

Slovakia

Cliniq s.r.o.

Bratislava, 811 09

Slovakia

ENDOMED s.r.o

Košice, 040 13

Slovakia

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, 940 34

Slovakia

GASTRO I. s.r.o.

Prešov, 080 01

Slovakia

Gastro LM s.r.o.

Prešov, 080 01

Slovakia

Vseobecna nemocnica Rimavska Sobota

Rimavská Sobota, 979 12

Slovakia

Hosp. Gral. Univ. Dr. Balmis

Alicante, 03010

Spain

Hosp. Clinic de Barcelona

Barcelona, 08036

Spain

Hosp. Arquitecto Marcide

Ferrol, 15405

Spain

Hosp. Univ. Dr. Josep Trueta

Girona, 17007

Spain

Hosp. Univ. de Torrejon

Madrid, 28850

Spain

Hosp. de Navarra

Navarra, 31008

Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706

Spain

Hosp. Virgen Macarena

Seville, 41009

Spain

Linkoping University Hospital

Linköping, 58185

Sweden

Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

Mölndal, 431 30

Sweden

Ersta sjukhus

Stockholm, 116 30

Sweden

Sodersjukhuset

Stockholm, 118 83

Sweden

Karolinska Universitetssjukhuset

Stockholm, 171 76

Sweden

Akademiska Sjukhuset

Uppsala, 751 85

Sweden

Barts Health NHS Trust

Greater London, E1 2AJ

United Kingdom

London North West University Healthcare NHS Trust

Greater London, NW10 7NS

United Kingdom

West Middlesex University Hospital

Iselworth, TW7 6AF

United Kingdom

University College London Hospitals Nhs Foundation Trust

London, NW1 2PG

United Kingdom

Royal Free Hospital

London, NW3 2QG

United Kingdom

Chelsea And Westminster Hospital

London, SW10 9NH

United Kingdom

Imperial College London

London, W120HS

United Kingdom

Norfolk and Norwich University Hospital

Norwich, NR4 7UQ

United Kingdom

New Cross Hospital

Wolverhampton, WV10 0QP

United Kingdom