A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Recruiting now · Phase 3

Conditions studied: Crohn Disease

In brief

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).

Key facts

Study ID

NCT07499232

Run by

Janssen Research & Development, LLC

People needed

530

Starts

2026-04-21

Expected to finish

2030-12-11

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• East View Medical Research — Mobile, Alabama, United States (enrolling)
• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States (enrolling)
• United Gastroenterologists — Los Alamitos, California, United States (enrolling)
• TLC Clinical Research Inc — Los Angeles, California, United States (enrolling)
• Clinnova Research — Anaheim, California, United States (enrolling)
• Medical Associates Research Group, Inc. — San Diego, California, United States (enrolling)
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
• Medical Research Center of Connecticut — Hamden, Connecticut, United States (enrolling)
• Green Leaf Clinical Trials — Jacksonville, Florida, United States (enrolling)
• Sanchez Clinical Research, Inc — Miami, Florida, United States (enrolling)
• Biodax Medical Research Trials — Miami, Florida, United States (enrolling)
• GI Pros Research — Naples, Florida, United States (enrolling)
• GCP Clinical Research — Tampa, Florida, United States (enrolling)
• Morehouse School of Medicine — Atlanta, Georgia, United States (enrolling)
• Gastroenterology Associates of Central GA — Macon, Georgia, United States (enrolling)
• Cotton-O'Neil Clinical Research Center — Topeka, Kansas, United States (enrolling)
• Gastroenterology Clinic of Acadiana — Lafayette, Louisiana, United States (enrolling)
• Michigan Center of Medical Research — Farmington Hills, Michigan, United States (enrolling)
• Westchester Putnam Gastroenterology — Carmel, New York, United States (enrolling)
• New York Gastroenterology Associates — New York, New York, United States (enrolling)
• Charlotte Gastroenterology and Hepatology, PLLC — Charlotte, North Carolina, United States (enrolling)
• Great Lakes Gastroenterology Research, LLC — Mentor, Ohio, United States (enrolling)
• Digestive Disease Specialists Inc — Oklahoma City, Oklahoma, United States (enrolling)
• Frontier Clinical Research — Uniontown, Pennsylvania, United States (enrolling)
• Palmetto Primary and Specialty Care Physicians, Charleston — Summerville, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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