Compares guselkumab with risankizumab in adults with Crohn's disease
Tests guselkumab against risankizumab in adults with moderate to severe Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Anaheim, Atlanta, Carmel, Carrollton, Chapel Hill, Charlotte, Clive, Colorado Springs, Dothan, Farmington Hills, Glen Burnie, Hamden, Jacksonville, Lafayette, Lancaster, Los Alamitos, Los Angeles, Lubbock, Macon, Mentor, Miami, Mobile, Naples, New Bedford, New York, Northbrook, Oklahoma City, Orlando, San Antonio, San Diego, Shreveport, Summerville, Tampa, Topeka, Tyler, and Uniontown, United StatesSee the 41 sites
- Phase
- Phase 3
Where in United States
- Clinnova ResearchAnaheim, United StatesTaking people
- Morehouse School of MedicineAtlanta, United StatesTaking people
- Atlanta Gastroenterology AssociatesAtlanta, United StatesNo longer taking part
- Westchester Putnam GastroenterologyCarmel, United StatesTaking people
- DFW Clinical TrialsCarrollton, United StatesTaking people
- University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- Charlotte Gastroenterology and Hepatology, PLLCCharlotte, United StatesTaking people
- Heartland Medical Research, Inc.Clive, United StatesTaking people
- Peak Gastroenterology AssociatesColorado Springs, United StatesTaking people
- Digestive Health Specialists of the SoutheastDothan, United StatesTaking people
- Michigan Center of Medical ResearchFarmington Hills, United StatesTaking people
- Woodholme Gastroenterology AssociatesGlen Burnie, United StatesTaking people
- Medical Research Center of ConnecticutHamden, United StatesTaking people
- Green Leaf Clinical TrialsJacksonville, United StatesTaking people
- Gastroenterology Clinic of AcadianaLafayette, United StatesTaking people
- Gastro Care InstituteLancaster, United StatesTaking people
- United GastroenterologistsLos Alamitos, United StatesTaking people
- GastroIntestinal BioscienceLos Angeles, United StatesTaking people
- TLC Clinical Research IncLos Angeles, United StatesTaking people
- Lubbock GastroenterologyLubbock, United StatesTaking people
- Gastroenterology Associates of Central GAMacon, United StatesTaking people
- Great Lakes Gastroenterology Research, LLCMentor, United StatesTaking people
- Biodax Medical Research TrialsMiami, United StatesTaking people
- Sanchez Clinical Research ,IncMiami, United StatesTaking people
- East View Medical ResearchMobile, United StatesTaking people
- GI PROS ResearchNaples, United StatesTaking people
- Lucida Clinical TrialsNew Bedford, United StatesTaking people
- New York Gastroenterology AssociatesNew York, United StatesTaking people
- Lenox Hill HospitalNew York, United StatesNo longer taking part
- Comprehensive Gastrointestinal Health LibertyvilleNorthbrook, United StatesTaking people
- Digestive Disease Specialists, IncOklahoma City, United StatesTaking people
- Orlando Health Digestive Health InstituteOrlando, United StatesTaking people
- Gastroenterology Research of America, LLCSan Antonio, United StatesTaking people
- Southern Star Research Institute, LLCSan Antonio, United StatesTaking people
- Medical Associates Research Group, Inc.San Diego, United StatesTaking people
- Louisiana State University Health Sciences Center ShreveportShreveport, United StatesTaking people
- Palmetto Primary and Specialty Care Physicians, CharlestonSummerville, United StatesTaking people
- GCP Clinical ResearchTampa, United StatesTaking people
- Cotton O'Neil Clinical Research CenterTopeka, United StatesTaking people
- The University of Texas Health Science Center at TylerTyler, United StatesTaking people
- Frontier Clinical ResearchUniontown, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07499232
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: 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; 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; Currently has or is suspected to have an abscess.