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RECRUITING
NCT07499232
PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

Official title: A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

530

Start Date

2026-04-21

Completion Date

2030-12-11

Last Updated

2026-08-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

Guselkumab

Guselkumab will be administered.

DRUG

Risankizumab

Risankizumab will be administered.

Locations (160)

Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

East View Medical Research

Mobile, Alabama, United States

Clinnova Research

Anaheim, California, United States

Gastro Care Institute

Lancaster, California, United States

United Gastroenterologists

Los Alamitos, California, United States

TLC Clinical Research Inc

Los Angeles, California, United States

GastroIntestinal Bioscience

Los Angeles, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

Medical Associates Research Group, Inc.

San Diego, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Medical Research Center of Connecticut

Hamden, Connecticut, United States

Green Leaf Clinical Trials

Jacksonville, Florida, United States

Sanchez Clinical Research, Inc

Miami, Florida, United States

Biodax Medical Research Trials

Miami, Florida, United States

GI Pros Research

Naples, Florida, United States

GCP Clinical Research

Tampa, Florida, United States

Morehouse School of Medicine

Atlanta, Georgia, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Gastroenterology Associates of Central GA

Macon, Georgia, United States

Comprehensive Gastrointestinal Health Libertyville

Northbrook, Illinois, United States

Cotton-O'Neil Clinical Research Center

Topeka, Kansas, United States

Gastroenterology Clinic of Acadiana

Lafayette, Louisiana, United States

Woodholme Gastroenterology Associates

Glen Burnie, Maryland, United States

Lucida Clinical Trials

New Bedford, Massachusetts, United States

Michigan Center of Medical Research

Farmington Hills, Michigan, United States

Westchester Putnam Gastroenterology

Carmel, New York, United States

New York Gastroenterology Associates

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Charlotte Gastroenterology and Hepatology, PLLC

Charlotte, North Carolina, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, United States

Frontier Clinical Research

Uniontown, Pennsylvania, United States

Palmetto Primary and Specialty Care Physicians, Charleston

Summerville, South Carolina, United States

DFW Clinical Trials

Carrollton, Texas, United States

UT Southwestern

Dallas, Texas, United States

Lubbock Gastroenterology

Lubbock, Texas, United States

Gastroenterology Research of America, LLC

San Antonio, Texas, United States

Southern Star Research Institute, LLC

San Antonio, Texas, United States

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States

LKH-Univ. Klinikum Graz

Graz, Austria

Medizinische Universitatsklinik Innsbruck

Innsbruck, Austria

Kepler Universitatsklinikum GmbH

Linz, Austria

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, Austria

Krankenhaus der Barmherzigen Brüder

Vienna, Austria

Klinikum Wels Grieskirchen

Wels, Austria

Universitatsklinikum Wiener Neustadt

Wiener Neustadt, Austria

ULB Erasme Ziekenhuis

Brussels, Belgium

Cliniques Universitaires Saint Luc

Brussels, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

Ghent University Hospital

Ghent, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

CHU de Liege

Liège, Belgium

Algemeen Ziekenhuis Delta

Roeselare, Belgium

Gastroenterology and Internal Medicine Research Institute (GIRI)

Edmonton, Alberta, Canada

GIRI Gastrointestinal Research Institute

Vancouver, British Columbia, Canada

Charlton Digestive Disease Centre

Hamilton, Ontario, Canada

London Digestive Disease Institute

London, Ontario, Canada

Taunton Surgical Centre

Oshawa, Ontario, Canada

Toronto Immune and Digestive Health Institute Inc

Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Clinique IMD

Montreal, Quebec, Canada

Changzhou No 2 Peoples Hospital

Changzhou, China

Chongqing General Hospital

Chongqing, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

The Sixth Affiliated Hospital Sun Yat sen University

Guangzhou, China

Zhongda Hospital Southeast University

Nanjing, China

Renmin Hospital of Wuhan University

Wuhan, China

Fakultni nemocnice Brno

Brno, Czechia

Vojenska nemocnice Brno

Brno, Czechia

Gastroenterologie, s.r.o., Hradec Kralove

Hradec Kralova, Czechia

Hepato-gastroenterologie HK, s.r.o.

Hradec Králové, Czechia

Fakultni Nemocnice Ostrava

Ostrava-Poruba, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Fakultni Thomayerova nemocnice

Prague, Czechia

Aarhus University Hospital

Aarhus C, Denmark

Sydvestjysk Sygehus

Esbjerg, Denmark

NAU New Aalborg University Hospital

Gistrup, Denmark

Herlev Hospital

Herlev, Denmark

Nordsjaellands Hospital, Hillerod

Hilleroed, Denmark

Hvidovre Hospital

Hvidovre, Denmark

Bispebjerg Hospital

København NV, Denmark

Odense UH og Svendberg sygehus

Odense C, Denmark

CHU Amiens Picardie

Amiens, France

Clermont Ferrand University Hospital

Clermont-Ferrand, France

Institut Prive MICI Clinique des Cedres

Échirolles, France

Aphm - Hopital Nord

Marseille, France

CHU Nantes - Hotel Dieu

Nantes, France

Clinique Ambroise Pare

Neuilly-sur-Seine, France

CHU Nimes

Nîmes, France

Aphp Hopital Saint Antoine

Paris, France

APHP - Hopital Bichat - Claude Bernard

Paris, France

Hospices Civils de Lyon CHU Lyon Sud

Pierre-Bénite, France

CHU de Reims

Reims, France

Centre Hospitalier Universitaire de Nancy - Hôpital Central

Vandœuvre-lès-Nancy, France

GASTRO-Studien

Berlin, Germany

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, Germany

Universitatsklinikum Erlangen

Erlangen, Germany

Praxiszentrum Fur Gastroenterologie und Endoskopie Grevenbroich

Grevenbroich, Germany

Universitatsklinikum Jena

Jena, Germany

Universitatsklinikum Schleswig Holstein Kiel

Kiel, Germany

St. Marien und St. Annastiftskrankenhaus

Ludwigshafen am Rhein, Germany

Universitaetsklinikum Mannheim

Mannheim, Germany

Klinikum rechts der Isar der TU Munchen

München, Germany

Obudai Egeszsegugyi Centrum Kft

Budapest, Hungary

Semmelweis Egyetem 1

Budapest, Hungary

Semmelweis Egyetem 2

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

Endomedix

Budapest, Hungary

Pannónia Magánorvosi Centrum Kft

Budapest, Hungary

Clinexpert Gyongyos Kft

Gyöngyös, Hungary

Szegedi Tudomanyegyetem

Szeged, Hungary

A O U Sant Orsola Malpighi

Bologna, Italy

Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano

Bolzano, Italy

Azienda Ospedaliero Universitaria San Martino

Genova, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Ospedale Mauriziano Torino

Torino, Italy

Maastricht UMC

Maastricht, Netherlands

Radboud Umcn

Nijmegen, Netherlands

St. Elisabeth Ziekenhuis

Tilburg, Netherlands

Centrum Medyczne Medis ManerMed Sp Z O O

Bydgoszcz, Poland

Centrum Medyczne Plejady

Krakow, Poland

Centrum Medyczne Promed

Krakow, Poland

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

Rzeszów, Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, Poland

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

Torun, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Medical Network Sp z o o

Warsaw, Poland

FNsP F. D. Roosevelta Banska Bystrica

Banská Bystrica, Slovakia

Cliniq s.r.o.

Bratislava, Slovakia

ENDOMED s.r.o

Košice, Slovakia

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, Slovakia

GASTRO I. s.r.o.

Prešov, Slovakia

Gastro LM s.r.o.

Prešov, Slovakia

Vseobecna nemocnica Rimavska Sobota

Rimavská Sobota, Slovakia

Hosp. Gral. Univ. Dr. Balmis

Alicante, Spain

Hosp. Clinic de Barcelona

Barcelona, Spain

Hosp. Arquitecto Marcide

Ferrol, Spain

Hosp. de Cabuenes

Gijón, Spain

Hosp. Univ. Dr. Josep Trueta

Girona, Spain

Hosp. Univ. de Torrejon

Madrid, Spain

Hosp. de Navarra

Navarra, Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, Spain

Hosp. Virgen Macarena

Seville, Spain

Linkoping University Hospital

Linköping, Sweden

Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

Mölndal, Sweden

Ersta sjukhus

Stockholm, Sweden

Sodersjukhuset

Stockholm, Sweden

Karolinska Universitetssjukhuset

Stockholm, Sweden

Akademiska Sjukhuset

Uppsala, Sweden

Barts Health NHS Trust

Greater London, United Kingdom

London North West University Healthcare NHS Trust

Greater London, United Kingdom

West Middlesex University Hospital

Iselworth, United Kingdom

University College London Hospitals Nhs Foundation Trust

London, United Kingdom

Royal Free Hospital

London, United Kingdom

Chelsea And Westminster Hospital

London, United Kingdom

Imperial College London

London, United Kingdom

Norfolk and Norwich University Hospital

Norwich, United Kingdom

New Cross Hospital

Wolverhampton, United Kingdom