Guselkumab versus risankizumab for moderate-to-severe Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Digestive Health Specialists of the Southeast
  Dothan, Alabama, United States Recruiting
• East View Medical Research
  Mobile, Alabama, United States Recruiting
• Clinnova Research
  Anaheim, California, United States Recruiting
• Gastro Care Institute
  Lancaster, California, United States Recruiting
• United Gastroenterologists
  Los Alamitos, California, United States Recruiting
• TLC Clinical Research Inc
  Los Angeles, California, United States Recruiting

+114 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing five advanced treatments for axial spondyloarthritis and psoriatic arthritis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.