NCT07499232From ClinicalTrials.govRecruiting

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

Crohn Disease

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Janssen Research & Development, LLC
Enrolment target: 530
Started: 21 April 2026
Main results due: 15 November 2028
Study sites: 161
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(161)

Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Recruiting
East View Medical Research
Mobile, Alabama, United States
Recruiting
Clinnova Research
Anaheim, California, United States
Recruiting
Gastro Care Institute
Lancaster, California, United States
Recruiting
United Gastroenterologists
Los Alamitos, California, United States
Recruiting
TLC Clinical Research Inc
Los Angeles, California, United States
Recruiting
GastroIntestinal Bioscience
Los Angeles, California, United States
Recruiting
Hoag Memorial Hospital
Newport Beach, California, United States
Suspended
Medical Associates Research Group, Inc.
San Diego, California, United States
Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Recruiting
Medical Research Center of Connecticut
Hamden, Connecticut, United States
Recruiting
Green Leaf Clinical Trials
Jacksonville, Florida, United States
Recruiting
Sanchez Clinical Research, Inc
Miami, Florida, United States
Recruiting
Biodax Medical Research Trials
Miami, Florida, United States
Recruiting
GI Pros Research
Naples, Florida, United States
Recruiting
GCP Clinical Research
Tampa, Florida, United States
Recruiting
Morehouse School of Medicine
Atlanta, Georgia, United States
Recruiting
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Suspended
Gastroenterology Associates of Central GA
Macon, Georgia, United States
Recruiting
Heartland Medical Research Inc
Clive, Iowa, United States
Recruiting
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, United States
Recruiting
Gastroenterology Clinic of Acadiana
Lafayette, Louisiana, United States
Recruiting
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States
Recruiting
Lucida Clinical Trials
New Bedford, Massachusetts, United States
Recruiting
Michigan Center of Medical Research
Farmington Hills, Michigan, United States
Recruiting
Westchester Putnam Gastroenterology
Carmel, New York, United States
Recruiting
New York Gastroenterology Associates
New York, New York, United States
Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Recruiting
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States
Recruiting
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Recruiting
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
Recruiting
Frontier Clinical Research
Uniontown, Pennsylvania, United States
Recruiting
Palmetto Primary and Specialty Care Physicians, Charleston
Summerville, South Carolina, United States
Recruiting
DFW Clinical Trials
Carrollton, Texas, United States
Recruiting
UT Southwestern
Dallas, Texas, United States
Suspended
Lubbock Gastroenterology
Lubbock, Texas, United States
Recruiting
Gastroenterology Research of America, LLC
San Antonio, Texas, United States
Recruiting
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Recruiting
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States
Recruiting
LKH-Univ. Klinikum Graz
Graz, Austria
Recruiting
Medizinische Universitatsklinik Innsbruck
Innsbruck, Austria
Recruiting
Kepler Universitatsklinikum GmbH
Linz, Austria
Recruiting
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, Austria
Recruiting
Krankenhaus der Barmherzigen Brüder
Vienna, Austria
Recruiting
Klinikum Wels Grieskirchen
Wels, Austria
Recruiting
Universitatsklinikum Wiener Neustadt
Wiener Neustadt, Austria
Recruiting
ULB Erasme Ziekenhuis
Brussels, Belgium
Recruiting
Cliniques Universitaires Saint Luc
Brussels, Belgium
Recruiting
Ziekenhuis Oost-Limburg
Genk, Belgium
Recruiting
Ghent University Hospital
Ghent, Belgium
Recruiting
Universitair Ziekenhuis Leuven
Leuven, Belgium
Recruiting
CHU de Liege
Liège, Belgium
Recruiting
Algemeen Ziekenhuis Delta
Roeselare, Belgium
Recruiting
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, Canada
Recruiting
GIRI Gastrointestinal Research Institute
Vancouver, British Columbia, Canada
Recruiting
Charlton Digestive Disease Centre
Hamilton, Ontario, Canada
Recruiting
London Digestive Disease Institute
London, Ontario, Canada
Recruiting
Taunton Surgical Centre
Oshawa, Ontario, Canada
Recruiting
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, Canada
Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Recruiting

Showing 60 of 161 sites — filter to narrow it down. 158 of the 161 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07499232. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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