RecruitingRecruiting
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
NCT07499232 · Janssen Research & Development, LLC
In plain English
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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
About this study
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
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
Study design
Enrollment target: 530 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-21
Estimated completion: 2030-12-11
Last updated: 2026-07-06
Interventions
Drug: GuselkumabDrug: Risankizumab
Primary outcomes
- • Number of Participants with Deep Remission at Week 52 (At Week 52)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (102)
Digestive Health Specialists of the SoutheastRecruiting
Dothan, Alabama, United States
East View Medical ResearchRecruiting
Mobile, Alabama, United States
Clinnova ResearchRecruiting
Anaheim, California, United States
United GastroenterologistsRecruiting
Los Alamitos, California, United States
TLC Clinical Research IncRecruiting
Los Angeles, California, United States
Hoag Memorial HospitalSuspended
Newport Beach, California, United States
Medical Associates Research Group, Inc.Recruiting
San Diego, California, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
Medical Research Center of ConnecticutRecruiting
Hamden, Connecticut, United States
Green Leaf Clinical TrialsRecruiting
Jacksonville, Florida, United States
Sanchez Clinical Research, IncRecruiting
Miami, Florida, United States
GCP Clinical ResearchRecruiting
Tampa, Florida, United States
Gastroenterology Associates of Central GARecruiting
Macon, Georgia, United States
Cotton-O'Neil Clinical Research CenterRecruiting
Topeka, Kansas, United States
Gastroenterology Clinic of AcadianaRecruiting
Lafayette, Louisiana, United States
Westchester Putnam GastroenterologyRecruiting
Carmel, New York, United States
New York Gastroenterology AssociatesRecruiting
New York, New York, United States
Charlotte Gastroenterology and Hepatology, PLLCRecruiting
Charlotte, North Carolina, United States
Great Lakes Gastroenterology Research, LLCRecruiting
Mentor, Ohio, United States
Digestive Disease Specialists IncRecruiting
Oklahoma City, Oklahoma, United States
Frontier Clinical ResearchRecruiting
Uniontown, Pennsylvania, United States
Palmetto Primary and Specialty Care Physicians, CharlestonRecruiting
Summerville, South Carolina, United States
DFW Clinical TrialsRecruiting
Carrollton, Texas, United States
Lubbock GastroenterologyRecruiting
Lubbock, Texas, United States
Southern Star Research Institute, LLCRecruiting
San Antonio, Texas, United States
Medizinische Universitatsklinik InnsbruckRecruiting
Innsbruck, Austria
LKH - Universitätsklinikum der PMU SalzburgRecruiting
Salzburg, Austria
Klinikum Wels GrieskirchenRecruiting
Wels, Austria
Ziekenhuis Oost-LimburgRecruiting
Genk, Belgium
Ghent University HospitalRecruiting
Ghent, Belgium
Universitair Ziekenhuis LeuvenRecruiting
Leuven, Belgium
Algemeen Ziekenhuis DeltaRecruiting
Roeselare, Belgium
GIRI Gastrointestinal Research InstituteRecruiting
Vancouver, British Columbia, Canada
Charlton Digestive Disease CentreRecruiting
Hamilton, Ontario, Canada
London Digestive Disease InstituteRecruiting
London, Ontario, Canada
Taunton Surgical CentreRecruiting
Oshawa, Ontario, Canada
Toronto Immune and Digestive Health Institute IncRecruiting
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de MontrealRecruiting
Montreal, Quebec, Canada
Clinique IMDRecruiting
Montreal, Quebec, Canada
The Sixth Affiliated Hospital Sun Yat sen UniversityRecruiting
Guangzhou, China
Vojenska nemocnice BrnoRecruiting
Brno, Czechia
Gastroenterologie, s.r.o., Hradec KraloveRecruiting
Hradec Kralova, Czechia
Hepato-gastroenterologie HK, s.r.o.Recruiting
Hradec Králové, Czechia
Fakultni Nemocnice OstravaRecruiting
Ostrava-Poruba, Czechia
Fakultni nemocnice Kralovske VinohradyRecruiting
Prague, Czechia
Fakultni Thomayerova nemocniceRecruiting
Prague, Czechia
Aarhus University HospitalRecruiting
Aarhus C, Denmark
Sydvestjysk SygehusRecruiting
Esbjerg, Denmark
NAU New Aalborg University HospitalRecruiting
Gistrup, Denmark
Herlev HospitalRecruiting
Herlev, Denmark
Nordsjaellands Hospital, HillerodRecruiting
Hilleroed, Denmark
Hvidovre HospitalRecruiting
Hvidovre, Denmark
Bispebjerg HospitalRecruiting
København NV, Denmark
Odense UH og Svendberg sygehusRecruiting
Odense C, Denmark
CHU Amiens PicardieRecruiting
Amiens, France
Clermont Ferrand University HospitalRecruiting
Clermont-Ferrand, France
Aphm - Hopital NordRecruiting
Marseille, France
CHU Nantes - Hotel DieuRecruiting
Nantes, France
Clinique Ambroise PareRecruiting
Neuilly-sur-Seine, France
CHU NimesRecruiting
Nîmes, France
Aphp Hopital Saint AntoineRecruiting
Paris, France
Centre Hospitalier Universitaire de Nancy - Hôpital CentralRecruiting
Vandœuvre-lès-Nancy, France
GASTRO-StudienRecruiting
Berlin, Germany
Praxiszentrum Fur Gastroenterologie und Endoskopie GrevenbroichRecruiting
Grevenbroich, Germany
Universitatsklinikum JenaRecruiting
Jena, Germany
Klinikum rechts der Isar der TU MunchenRecruiting
München, Germany
Radboud UmcnRecruiting
Nijmegen, Netherlands
St. Elisabeth ZiekenhuisRecruiting
Tilburg, Netherlands
Centrum Medyczne Medis ManerMed Sp Z O ORecruiting
Bydgoszcz, Poland
Centrum Medyczne PlejadyRecruiting
Krakow, Poland
Centrum Medyczne PromedRecruiting
Krakow, Poland
Centrum Medyczne 'Medyk' Sp. z o.o. K.Recruiting
Rzeszów, Poland
Twoja Przychodnia - Szczecinskie Centrum MedyczneRecruiting
Szczecin, Poland
GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i EndoskopiiRecruiting
Torun, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyRecruiting
Warsaw, Poland
Medical Network Sp z o oRecruiting
Warsaw, Poland
FNsP F. D. Roosevelta Banska BystricaRecruiting
Banská Bystrica, Slovakia
Cliniq s.r.o.Recruiting
Bratislava, Slovakia
ENDOMED s.r.oRecruiting
Košice, Slovakia
Fakultna nemocnica s poliklinikou Nove ZamkyRecruiting
Nové Zámky, Slovakia
GASTRO I. s.r.o.Recruiting
Prešov, Slovakia
Gastro LM s.r.o.Recruiting
Prešov, Slovakia
Hosp. Clinic de BarcelonaRecruiting
Barcelona, Spain
Hosp. Arquitecto MarcideRecruiting
Ferrol, Spain
Hosp. Univ. Dr. Josep TruetaRecruiting
Girona, Spain
Hosp. Univ. de TorrejonRecruiting
Madrid, Spain
Hosp. de NavarraRecruiting
Navarra, Spain
Hosp. Clinico Univ. de SantiagoRecruiting
Santiago de Compostela, Spain
Hosp. Virgen MacarenaRecruiting
Seville, Spain
Linkoping University HospitalRecruiting
Linköping, Sweden
Sahlgrenska Universitetssjukhuset, Mölndal SjukhusRecruiting
Mölndal, Sweden
Ersta sjukhusRecruiting
Stockholm, Sweden
SodersjukhusetRecruiting
Stockholm, Sweden
Karolinska UniversitetssjukhusetRecruiting
Stockholm, Sweden
Akademiska SjukhusetRecruiting
Uppsala, Sweden
Barts Health NHS TrustRecruiting
Greater London, United Kingdom
London North West University Healthcare NHS TrustRecruiting
Greater London, United Kingdom
University College London Hospitals Nhs Foundation TrustRecruiting
London, United Kingdom
Chelsea And Westminster HospitalRecruiting
London, United Kingdom
Imperial College LondonRecruiting
London, United Kingdom
Norfolk and Norwich University HospitalRecruiting
Norwich, United Kingdom
New Cross HospitalRecruiting
Wolverhampton, United Kingdom