A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Bologna, Bolzano, Genova, Milan, Roma, Rozzano, and Torino, ItalySee the 7 sites
- Phase
- Phase 3
Where in Italy
- A O U Sant Orsola MalpighiBologna, ItalyTaking people
- Azienda Sanitaria dell'Alto Adige - Ospedale di BolzanoBolzano, ItalyTaking people
- Azienda Ospedaliero Universitaria San MartinoGenova, ItalyTaking people
- IRCCS Ospedale San RaffaeleMilan, ItalyTaking people
- Fondazione Policlinico Universitario A. Gemelli IRCCSRoma, ItalyTaking people
- Istituto Clinico HumanitasRozzano, ItalyTaking people
- Ospedale Mauriziano TorinoTorino, ItalyTaking 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.