What this study is
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).
What's being tested
- Guselkumab
Intervention · DRUG
Guselkumab will be administered.
- Risankizumab
Intervention · DRUG
Risankizumab will be administered.
Study details
- 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
- Sponsor
- Janssen Research & Development, LLC
- Conditions
- Crohn Disease
- Enrolling
- 530 people
- Starts
- 2026-04-21
- Est. completion
- 2030-12-11
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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:; a minimum score of 1 for the component of "size of ulcers" AND; 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (164)
162 openDigestive Health Specialists of the Southeast
Dothan, Alabama, United States
RecruitingEast View Medical Research
Mobile, Alabama, United States
RecruitingClinnova Research
Anaheim, California, United States
RecruitingGastro Care Institute
Lancaster, California, United States
RecruitingUnited Gastroenterologists
Los Alamitos, California, United States
RecruitingTLC Clinical Research Inc
Los Angeles, California, United States
RecruitingGastroIntestinal Bioscience
Los Angeles, California, United States
RecruitingMedical Associates Research Group, Inc.
San Diego, California, United States
RecruitingPeak Gastroenterology Associates
Colorado Springs, Colorado, United States
RecruitingMedical Research Center of Connecticut
Hamden, Connecticut, United States
RecruitingGreen Leaf Clinical Trials
Jacksonville, Florida, United States
RecruitingSanchez Clinical Research, Inc
Miami, Florida, United States
RecruitingBiodax Medical Research Trials
Miami, Florida, United States
RecruitingGI Pros Research
Naples, Florida, United States
RecruitingOrlando Health Digestive Health Institute
Orlando, Florida, United States
RecruitingGCP Clinical Research
Tampa, Florida, United States
RecruitingMorehouse School of Medicine
Atlanta, Georgia, United States
RecruitingGastroenterology Associates of Central GA
Macon, Georgia, United States
RecruitingComprehensive Gastrointestinal Health Libertyville
Northbrook, Illinois, United States
RecruitingHeartland Medical Research Inc
Clive, Iowa, United States
RecruitingCotton-O'Neil Clinical Research Center
Topeka, Kansas, United States
RecruitingGastroenterology Clinic of Acadiana
Lafayette, Louisiana, United States
RecruitingLouisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States
RecruitingWoodholme Gastroenterology Associates
Glen Burnie, Maryland, United States
RecruitingLucida Clinical Trials
New Bedford, Massachusetts, United States
RecruitingMichigan Center of Medical Research
Farmington Hills, Michigan, United States
RecruitingWestchester Putnam Gastroenterology
Carmel, New York, United States
RecruitingNew York Gastroenterology Associates
New York, New York, United States
RecruitingUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RecruitingCharlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States
RecruitingGreat Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
RecruitingDigestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
RecruitingFrontier Clinical Research
Uniontown, Pennsylvania, United States
RecruitingPalmetto Primary and Specialty Care Physicians, Charleston
Summerville, South Carolina, United States
RecruitingDFW Clinical Trials
Carrollton, Texas, United States
RecruitingLubbock Gastroenterology
Lubbock, Texas, United States
RecruitingGastroenterology Research of America, LLC
San Antonio, Texas, United States
RecruitingSouthern Star Research Institute, LLC
San Antonio, Texas, United States
RecruitingThe University of Texas Health Science Center at Tyler
Tyler, Texas, United States
RecruitingAtlanta Gastroenterology Associates
Atlanta, Georgia, United States
SuspendedLenox Hill Hospital
New York, New York, United States
Suspended
123 sites outside the US
LKH-Univ. Klinikum Graz
Graz, Austria
RecruitingMedizinische Universitatsklinik Innsbruck
Innsbruck, Austria
RecruitingKepler Universitatsklinikum GmbH
Linz, Austria
RecruitingLKH - Universitätsklinikum der PMU Salzburg
Salzburg, Austria
RecruitingKrankenhaus der Barmherzigen Brüder
Vienna, Austria
RecruitingMedical University Vienna
Vienna, Austria
RecruitingKlinikum Wels Grieskirchen
Wels, Austria
RecruitingUniversitatsklinikum Wiener Neustadt
Wiener Neustadt, Austria
RecruitingULB Erasme Ziekenhuis
Brussels, Belgium
RecruitingCliniques Universitaires Saint Luc
Brussels, Belgium
RecruitingZiekenhuis Oost-Limburg
Genk, Belgium
RecruitingGhent University Hospital
Ghent, Belgium
RecruitingUniversitair Ziekenhuis Leuven
Leuven, Belgium
RecruitingCHU de Liege
Liège, Belgium
RecruitingAlgemeen Ziekenhuis Delta
Roeselare, Belgium
RecruitingGastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, Canada
RecruitingGIRI Gastrointestinal Research Institute
Vancouver, British Columbia, Canada
RecruitingCharlton Digestive Disease Centre
Hamilton, Ontario, Canada
RecruitingLondon Digestive Disease Institute
London, Ontario, Canada
RecruitingTaunton Surgical Centre
Oshawa, Ontario, Canada
RecruitingToronto Immune and Digestive Health Institute Inc
Toronto, Ontario, Canada
RecruitingCentre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
RecruitingClinique IMD
Montreal, Quebec, Canada
RecruitingChangzhou No 2 Peoples Hospital
Changzhou, China
RecruitingChongqing General Hospital
Chongqing, China
RecruitingThe First Affiliated Hospital of Fujian Medical University
Fuzhou, China
RecruitingThe Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
RecruitingThe Sixth Affiliated Hospital Sun Yat sen University
Guangzhou, China
RecruitingZhongda Hospital Southeast University
Nanjing, China
RecruitingRenmin Hospital of Wuhan University
Wuhan, China
RecruitingFakultni nemocnice Brno
Brno, Czechia
RecruitingVojenska nemocnice Brno
Brno, Czechia
RecruitingGastroenterologie, s.r.o., Hradec Kralove
Hradec Kralova, Czechia
RecruitingHepato-gastroenterologie HK, s.r.o.
Hradec Králové, Czechia
RecruitingFakultni Nemocnice Ostrava
Ostrava-Poruba, Czechia
RecruitingFakultni nemocnice Kralovske Vinohrady
Prague, Czechia
RecruitingFakultni Thomayerova nemocnice
Prague, Czechia
RecruitingAarhus University Hospital
Aarhus C, Denmark
RecruitingSydvestjysk Sygehus
Esbjerg, Denmark
RecruitingNAU New Aalborg University Hospital
Gistrup, Denmark
RecruitingHerlev Hospital
Herlev, Denmark
RecruitingNordsjaellands Hospital, Hillerod
Hilleroed, Denmark
RecruitingHvidovre Hospital
Hvidovre, Denmark
RecruitingBispebjerg Hospital
København NV, Denmark
RecruitingOdense UH og Svendberg sygehus
Odense C, Denmark
RecruitingCHU Amiens Picardie
Amiens, France
RecruitingClermont Ferrand University Hospital
Clermont-Ferrand, France
RecruitingInstitut Prive MICI Clinique des Cedres
Échirolles, France
RecruitingAphm - Hopital Nord
Marseille, France
RecruitingCHU Nantes - Hotel Dieu
Nantes, France
RecruitingClinique Ambroise Pare
Neuilly-sur-Seine, France
RecruitingCHU Nimes
Nîmes, France
RecruitingAphp Hopital Saint Antoine
Paris, France
RecruitingAPHP - Hopital Bichat - Claude Bernard
Paris, France
RecruitingHospices Civils de Lyon CHU Lyon Sud
Pierre-Bénite, France
RecruitingCHU de Reims
Reims, France
RecruitingCentre Hospitalier Universitaire de Nancy - Hôpital Central
Vandœuvre-lès-Nancy, France
RecruitingGASTRO-Studien
Berlin, Germany
RecruitingCharite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, Germany
RecruitingUniversitatsklinikum Erlangen
Erlangen, Germany
RecruitingPraxiszentrum Fur Gastroenterologie und Endoskopie Grevenbroich
Grevenbroich, Germany
RecruitingUniversitatsklinikum Jena
Jena, Germany
RecruitingUniversitatsklinikum Schleswig Holstein Kiel
Kiel, Germany
RecruitingSt. Marien und St. Annastiftskrankenhaus
Ludwigshafen am Rhein, Germany
RecruitingUniversitaetsklinikum Mannheim
Mannheim, Germany
RecruitingKlinikum rechts der Isar der TU Munchen
München, Germany
RecruitingObudai Egeszsegugyi Centrum Kft
Budapest, Hungary
RecruitingSemmelweis Egyetem 1
Budapest, Hungary
RecruitingSemmelweis Egyetem 2
Budapest, Hungary
RecruitingSemmelweis Egyetem
Budapest, Hungary
RecruitingEndomedix
Budapest, Hungary
RecruitingPannónia Magánorvosi Centrum Kft
Budapest, Hungary
RecruitingClinexpert Gyongyos Kft
Gyöngyös, Hungary
RecruitingSzegedi Tudomanyegyetem
Szeged, Hungary
RecruitingA O U Sant Orsola Malpighi
Bologna, Italy
RecruitingAzienda Sanitaria dell'Alto Adige - Ospedale di Bolzano
Bolzano, Italy
RecruitingAzienda Ospedaliero Universitaria San Martino
Genova, Italy
RecruitingIRCCS Ospedale San Raffaele
Milan, Italy
RecruitingFondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy
RecruitingIstituto Clinico Humanitas
Rozzano, Italy
RecruitingOspedale Mauriziano Torino
Torino, Italy
RecruitingMaastricht UMC
Maastricht, Netherlands
RecruitingRadboud Umcn
Nijmegen, Netherlands
RecruitingSt. Elisabeth Ziekenhuis
Tilburg, Netherlands
RecruitingCentrum Medyczne Medis ManerMed Sp Z O O
Bydgoszcz, Poland
RecruitingCentrum Medyczne Plejady
Krakow, Poland
RecruitingCentrum Medyczne Promed
Krakow, Poland
RecruitingCentrum Medyczne 'Medyk' Sp. z o.o. K.
Rzeszów, Poland
RecruitingTwoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, Poland
RecruitingGASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
Torun, Poland
RecruitingNarodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland
RecruitingMedical Network Sp z o o
Warsaw, Poland
RecruitingFNsP F. D. Roosevelta Banska Bystrica
Banská Bystrica, Slovakia
RecruitingCliniq s.r.o.
Bratislava, Slovakia
RecruitingENDOMED s.r.o
Košice, Slovakia
RecruitingFakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, Slovakia
RecruitingGASTRO I. s.r.o.
Prešov, Slovakia
RecruitingGastro LM s.r.o.
Prešov, Slovakia
RecruitingVseobecna nemocnica Rimavska Sobota
Rimavská Sobota, Slovakia
RecruitingHosp. Gral. Univ. Dr. Balmis
Alicante, Spain
RecruitingHosp. Clinic de Barcelona
Barcelona, Spain
RecruitingHosp. Arquitecto Marcide
Ferrol, Spain
RecruitingHosp. de Cabuenes
Gijón, Spain
RecruitingHosp. Univ. Dr. Josep Trueta
Girona, Spain
RecruitingHosp. Univ. de Torrejon
Madrid, Spain
RecruitingHosp. de Navarra
Navarra, Spain
RecruitingHosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain
RecruitingHosp. Virgen Macarena
Seville, Spain
RecruitingLinkoping University Hospital
Linköping, Sweden
RecruitingSahlgrenska Universitetssjukhuset, Mölndal Sjukhus
Mölndal, Sweden
RecruitingErsta sjukhus
Stockholm, Sweden
RecruitingSodersjukhuset
Stockholm, Sweden
RecruitingKarolinska Universitetssjukhuset
Stockholm, Sweden
RecruitingAkademiska Sjukhuset
Uppsala, Sweden
RecruitingBarts Health NHS Trust
Greater London, United Kingdom
RecruitingLondon North West University Healthcare NHS Trust
Greater London, United Kingdom
RecruitingWest Middlesex University Hospital
Iselworth, United Kingdom
RecruitingUniversity College London Hospitals Nhs Foundation Trust
London, United Kingdom
RecruitingRoyal Free Hospital
London, United Kingdom
RecruitingChelsea And Westminster Hospital
London, United Kingdom
RecruitingImperial College London
London, United Kingdom
RecruitingNorfolk and Norwich University Hospital
Norwich, United Kingdom
RecruitingNew Cross Hospital
Wolverhampton, United Kingdom
Recruiting
Study team
Sponsor
Janssen Research & Development, LLC
Study ID CNTO1959CRD3009
Study director
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.