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

In plain English

What this trial is testing

This study is testing Guselkumab (a drug) and Risankizumab (a drug) as a possible treatment. Condition(s) listed: Crohn Disease.

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

• Ages 18 and older
• Any sex

Some of the main requirements, copied from the record:

• 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…
• 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

Plus 1 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 530 participants are expected to take part.
• The study has 2 groups.
• Start date: 2026-04-21.
• Main results expected around 2028-11-15 (estimate from the record).
• 161 study sites listed (158 marked recruiting) in Austria, Belgium, Canada, China and Czechia and 12 more countries.

Groups in this study

• Guselkumab (listed as: experimental group)
• Risankizumab (listed as: experimental group)

Main thing being measured

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

In the researchers’ words

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).

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.