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A Study of Guselkumab Versus Risankizumab for Crohn's Disease

This study is comparing two approved medications, guselkumab and risankizumab, to see which works better for people with moderately to severely active Crohn's disease (a long-term condition causing severe inflammation of the intestinal tract). Researchers want to find out how many participants achieve "deep remission" (a significant improvement in symptoms and gut healing) after 52 weeks. You may be able to join if you are 18 or older and have had Crohn's disease for at least 12 weeks, confirmed by tests like X-rays or endoscopy. The study aims to enroll about 530 participants. The current recruitment status is unclear.

Study design
This interventional study plans to enroll about 530 participants. It compares guselkumab to risankizumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed for deep remission at Week 52.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07499232

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~530 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:GuselkumabRisankizumab

At a glance

Recruiting sites
156 of 160 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Deep Remission at Week 52
Measured over At Week 52

Conditions

Crohn Disease

Explore related trials

Crohn Disease

Where it's being run

160 sites across 38 states
France12
Germany9
Spain9
United Kingdom9
Denmark8
Hungary8
Poland8
California7

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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:
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
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 trial measures

  • Number of Participants with Deep Remission at Week 52At Week 52

    Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as Crohn's Disease Activity Index (CDAI) score less than (\<) 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity. Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no sub score greater than (\>) 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.