Guselkumab versus risankizumab for moderate-to-severe 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

This comparison tests whether guselkumab or risankizumab works better to reduce intestinal inflammation in people with moderately to severely active Crohn's disease.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 530 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Janssen Research & Development, LLC (industry)
• Drugs / interventions: guselkumab, risankizumab
• Locations: 11 sites (Anaheim, California and 10 other locations)
• Trial ID: NCT07499232 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares two IL-23–targeting biologic therapies, guselkumab and risankizumab, in adults with moderately to severely active Crohn's disease. Eligible participants must have had Crohn's for at least 12 weeks, a baseline CDAI of 220–450, and central endoscopy confirmation of ulcers meeting predefined SES‑CD thresholds. Participants will be assigned to receive either guselkumab or risankizumab and will be followed for clinical and endoscopic responses. Key outcomes include symptomatic improvement by CDAI and endoscopic healing as measured by SES‑CD.

Who should consider this trial

Good fit: Adults with Crohn's disease of at least 12 weeks' duration who have moderately to severely active disease (CDAI 220–450) and baseline endoscopic ulcers meeting SES‑CD thresholds are the intended participants.

Not a fit: People with mild Crohn's (CDAI <220), no endoscopic ulceration, certain comorbidities, or who fall outside the trial's enrollment criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the comparison could identify a more effective IL‑23 therapy and expand treatment options for people with moderate-to-severe Crohn's disease.

How similar studies have performed: Previous trials of IL‑23 inhibitors, including risankizumab, have shown efficacy in Crohn's disease while guselkumab's effects in Crohn's have been less established, making this direct comparison relatively novel.

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

Where this trial is running

Anaheim, California and 10 other locations

• Clinnova Research — Anaheim, California, United States (RECRUITING)
• TLC Clinical Research Inc — Los Angeles, California, United States (RECRUITING)
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (RECRUITING)
• Sanchez Clinical Research, Inc — Miami, Florida, United States (RECRUITING)
• GCP Clinical Research — Tampa, Florida, United States (RECRUITING)
• Cotton-O'Neil Clinical Research Center — Topeka, Kansas, United States (RECRUITING)
• New York Gastroenterology Associates — New York, New York, United States (RECRUITING)
• Southern Star Research Institute, LLC — San Antonio, Texas, United States (RECRUITING)
• GIRI Gastrointestinal Research Institute — Vancouver, British Columbia, Canada (RECRUITING)
• London Digestive Disease Institute — London, Ontario, Canada (RECRUITING)
• Clinique IMD — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: Study Contact

Conditions: Crohn Disease