NCT07499232RecruitingPhase 3
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 530 (estimated)
- First submitted
- 23 Mar 2026
- Start date
- 21 Apr 2026
- Primary completion date
- 15 Nov 2028
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Crohn's disease
- NCT number
- NCT07499232
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 530
- From 21 Apr 2026 to the primary completion date, 15 Nov 2028
- 164 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Has an active fistula during screening or at Week 0 with an anticipated need for surgery
- Currently has a malignancy or has a history of malignancy within 5 years before screening
Other
- Currently has or is suspected to have an abscess
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (164)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lkh-Univ. Klinikum Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Medizinische Universitatsklinik Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Kepler Universitatsklinikum GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| LKH - Universitätsklinikum der PMU Salzburg Coordinator of this site? Confirm its status | Salzburg | Austria | Recruiting |
| Krankenhaus der Barmherzigen Brüder Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Medical University Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Klinikum Wels-Grieskirchen Coordinator of this site? Confirm its status | Wels | Austria | Recruiting |
| Universitätsklinikum Wiener Neustadt Coordinator of this site? Confirm its status | Wiener Neustadt | Austria | Recruiting |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| ULB Erasme Ziekenhuis Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Recruiting |
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Universitair Ziekenhuis Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| CHU de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Gastroenterology and Internal Medicine Research Institute (GIRI) Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Charlton Digestive Disease Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| London Digestive Disease Institute Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Clinique IMD Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Taunton Surgical Centre Coordinator of this site? Confirm its status | Oshawa | Canada | Recruiting |
| Toronto Immune and Digestive Health Institute Inc Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| GIRI Gastrointestinal Research Institute Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Changzhou No 2 Peoples Hospital Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| Chongqing General Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| The Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhongda Hospital Southeast University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Vojenská Nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Gastroenterologie, s.r.o., Hradec Kralove Coordinator of this site? Confirm its status | Hradec Kralova | Czechia | Recruiting |
| Hepato-Gastroenterologie HK, s.r.o. Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| Fakultni Nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava - Poruba | Czechia | Recruiting |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF) Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| GASTRO-Studien Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitätsklinikum Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| Praxiszentrum Fur Gastroenterologie und Endoskopie Grevenbroich Coordinator of this site? Confirm its status | Grevenbroich | Germany | Recruiting |
| Universitätsklinikum Jena Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Universitatsklinikum Schleswig Holstein Kiel Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| St. Marien und St. Annastiftskrankenhaus Coordinator of this site? Confirm its status | Ludwigshafen am Rhein | Germany | Recruiting |
| Universitaetsklinikum Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Klinikum rechts der Isar der TU München Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus C | Denmark | Recruiting |
| Sydvestjysk Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Recruiting |
| NAU New Aalborg University Hospital Coordinator of this site? Confirm its status | Gistrup | Denmark | Recruiting |
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| Nordsjaellands Hospital, Hillerod Coordinator of this site? Confirm its status | Hilleroed | Denmark | Recruiting |
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Recruiting |
| Bispebjerg Hospital Coordinator of this site? Confirm its status | København NV | Denmark | Recruiting |
| Odense UH og Svendberg sygehus Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Hosp. Gral. Univ. Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hosp Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hosp. Arquitecto Marcide Coordinator of this site? Confirm its status | Ferrol | Spain | Recruiting |
| Hosp. de Cabuenes Coordinator of this site? Confirm its status | Gijón | Spain | Recruiting |
| Hosp. Univ. Dr. Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
| Hosp. Univ. de Torrejon Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hosp. de Navarra Coordinator of this site? Confirm its status | Navarra | Spain | Recruiting |
| Hosp. Clinico Univ. de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hosp. Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| Clermont-Ferrand University Hospital Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Institut Prive MICI Clinique des Cedres Coordinator of this site? Confirm its status | Échirolles | France | Recruiting |
| APHM - Hopital Nord Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| CHU Nantes-Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Clinique Ambroise Pare Coordinator of this site? Confirm its status | Neuilly-sur-Seine | France | Recruiting |
| CHU Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| APHP-Hôpital Bichat - Claude Bernard Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| APHP - Hôpital Saint Antoine Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hospices Civils de Lyon CHU Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| CHU de Reims Coordinator of this site? Confirm its status | Reims | France | Recruiting |
| Centre Hospitalier Universitaire de Nancy - Hôpital Central Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | Greater London | United Kingdom | Recruiting |
| London North West University Healthcare NHS Trust Coordinator of this site? Confirm its status | Greater London | United Kingdom | Recruiting |
| West Middlesex University Hospital Coordinator of this site? Confirm its status | Iselworth | United Kingdom | Recruiting |
| Chelsea And Westminster Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Imperial College London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Norfolk and Norwich University Hospital Coordinator of this site? Confirm its status | Norwich | United Kingdom | Recruiting |
| New Cross Hospital Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Recruiting |
| Endomedix Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Obudai Egeszsegugyi Centrum Kft Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Semmelweis Egyetem Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Semmelweis Egyetem 2 Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Semmelweis Egyetem 1 Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Pannónia Magánorvosi Centrum Kft Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Clinexpert Gyöngyös Kft. Coordinator of this site? Confirm its status | Gyöngyös | Hungary | Recruiting |
| Szegedi Tudomanyegyetem Coordinator of this site? Confirm its status | Szeged | Hungary | Recruiting |
| A O U Sant Orsola Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano Coordinator of this site? Confirm its status | Bolzano | Italy | Recruiting |
| Azienda Ospedaliero Universitaria San Martino Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Ospedale Mauriziano Torino Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Radboud Umcn Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| St. Elisabeth Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
| Centrum Medyczne Medis ManerMed Sp Z O O Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Centrum Medyczne PROMED Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Centrum Medyczne Plejady Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Centrum Medyczne 'Medyk' Sp. z o.o. K. Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Linkoping University Hospital Coordinator of this site? Confirm its status | Linköping | Sweden | Recruiting |
| Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus Coordinator of this site? Confirm its status | Mölndal | Sweden | Recruiting |
| Ersta sjukhus Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Södersjukhuset Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Karolinska Universitetssjukhuset Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Akademiska sjukhuset Coordinator of this site? Confirm its status | Uppsala | Sweden | Recruiting |
| FNsP F. D. Roosevelta Banska Bystrica Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Recruiting |
| Cliniq s.r.o. Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
| ENDOMED, s.r.o. Coordinator of this site? Confirm its status | Košice | Slovakia | Recruiting |
| Fakultna nemocnica s poliklinikou Nove Zamky Coordinator of this site? Confirm its status | Nové Zámky | Slovakia | Recruiting |
| GASTRO I., s.r.o. Coordinator of this site? Confirm its status | Prešov | Slovakia | Recruiting |
| Gastro LM s.r.o. Coordinator of this site? Confirm its status | Prešov | Slovakia | Recruiting |
| Vseobecna nemocnica Rimavska Sobota Coordinator of this site? Confirm its status | Rimavská Sobota | Slovakia | Recruiting |
| Clinnova Research Coordinator of this site? Confirm its status | Anaheim | United States | Recruiting |
| Morehouse School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Atlanta Gastroenterology Associates Coordinator of this site? Confirm its status | Atlanta | United States | Suspended |
| Westchester Putnam Gastroenterology Coordinator of this site? Confirm its status | Carmel | United States | Recruiting |
| DFW Clinical Trials Coordinator of this site? Confirm its status | Carrollton | United States | Recruiting |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Charlotte Gastroenterology and Hepatology, PLLC Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Heartland Medical Research, Inc. Coordinator of this site? Confirm its status | Clive | United States | Recruiting |
| Peak Gastroenterology Associates Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Digestive Health Specialists of the Southeast Coordinator of this site? Confirm its status | Dothan | United States | Recruiting |
| Michigan Center of Medical Research Coordinator of this site? Confirm its status | Farmington Hills | United States | Recruiting |
| Woodholme Gastroenterology Associates Coordinator of this site? Confirm its status | Glen Burnie | United States | Recruiting |
| Medical Research Center of Connecticut Coordinator of this site? Confirm its status | Hamden | United States | Recruiting |
| Green Leaf Clinical Trials Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Gastroenterology Clinic of Acadiana Coordinator of this site? Confirm its status | Lafayette | United States | Recruiting |
| Gastro Care Institute Coordinator of this site? Confirm its status | Lancaster | United States | Recruiting |
| United Gastroenterologists Coordinator of this site? Confirm its status | Los Alamitos | United States | Recruiting |
| TLC Clinical Research Inc Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| GastroIntestinal Bioscience Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Lubbock Gastroenterology Coordinator of this site? Confirm its status | Lubbock | United States | Recruiting |
| Gastroenterology Associates of Central GA Coordinator of this site? Confirm its status | Macon | United States | Recruiting |
| Great Lakes Gastroenterology Research, LLC Coordinator of this site? Confirm its status | Mentor | United States | Recruiting |
| Sanchez Clinical Research ,Inc Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Biodax Medical Research Trials Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| East View Medical Research Coordinator of this site? Confirm its status | Mobile | United States | Recruiting |
| GI PROS Research Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Lucida Clinical Trials Coordinator of this site? Confirm its status | New Bedford | United States | Recruiting |
| Lenox Hill Hospital Coordinator of this site? Confirm its status | New York | United States | Suspended |
| New York Gastroenterology Associates Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Comprehensive Gastrointestinal Health Libertyville Coordinator of this site? Confirm its status | Northbrook | United States | Recruiting |
| Digestive Disease Specialists, Inc Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Orlando Health Digestive Health Institute Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Southern Star Research Institute, LLC Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Gastroenterology Research of America, LLC Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Medical Associates Research Group, Inc. Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Louisiana State University Health Sciences Center Shreveport Coordinator of this site? Confirm its status | Shreveport | United States | Recruiting |
| Palmetto Primary and Specialty Care Physicians, Charleston Coordinator of this site? Confirm its status | Summerville | United States | Recruiting |
| GCP Clinical Research Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Cotton O'Neil Clinical Research Center Coordinator of this site? Confirm its status | Topeka | United States | Recruiting |
| The University of Texas Health Science Center at Tyler Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
| Frontier Clinical Research Coordinator of this site? Confirm its status | Uniontown | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.