Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called guselkumab in people with Crohn's disease, a condition causing ongoing inflammation in the digestive tract. A total of 350 people took part, split into three groups: 118 received a placebo (a dummy treatment with no active ingredient), 117 received guselkumab at one dose combination, and 115 received guselkumab at a second dose combination. The trial measured several things, including whether participants reached "clinical remission" — meaning their disease activity score dropped below a certain level — as well as whether there were signs of improvement seen during a camera examination of the bowel (called endoscopic response). The reported data shows that by week 12, around 56% of participants in the combined guselkumab groups reached clinical remission, compared with around 21% in the placebo group. For the bowel camera measure at week 12, about 41% of the guselkumab group showed a meaningful improvement, compared with about 21% in the placebo group. By week 24, the reported remission figures were approximately 61% and 58% for the two guselkumab dose groups respectively, versus about 21% for placebo. For a separate patient-reported measure at week 12 — based on pain and stool frequency scores — about 49% of the guselkumab group met the target, compared with about 17% in the placebo group. Regarding unwanted medical events recorded up to week 48, the reported data shows these were noted in about 66% of placebo participants, 83% in one guselkumab group, and 80% in the other; the trial did not draw conclusions about the cause of these events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 40113101) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Crohn's Disease and Colitis Trial, Active, Not Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with Crohn's disease for at least 3 months.
- Your Crohn's disease is considered moderate to severe, based on symptoms such as stool frequency, abdominal pain, and results from a bowel camera examination (endoscopy).
- Previous treatments for Crohn's disease — either standard medications or biologic (advanced) therapies — have not worked well enough for you, or you have had bad reactions to them.
Who may not be able to join:
- You have been diagnosed with ulcerative colitis or a similar bowel condition where the exact type is unclear (sometimes called indeterminate colitis).
- Your Crohn's disease has led to serious complications that would require surgery, or that would make it hard to measure whether the treatment is working (confirm with trial site).
- The doses of any current Crohn's disease medications you are taking have not been kept stable (confirm with trial site for what counts as "stable").
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Who Achieved Clinical Remission at Week 12; Percentage of Participants Who Achieved Endoscopic Response at Week 12
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.