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 (known as GALAXI 1, 2, and 3) enrolled a total of 1,409 adults with Crohn's disease across three related sub-studies. Participants were assigned to receive different doses of a medicine called guselkumab (given by drip into a vein and then by injection under the skin), a comparison medicine called ustekinumab, or a placebo (a dummy treatment with no active ingredient). The trial measured disease activity using two main tools: a scoring system based on symptoms called the CDAI (where lower scores mean less disease activity), and a camera examination of the bowel called an endoscopy (where lower scores also mean less disease activity). The studies ran for up to 48 weeks. The reported data shows the following for each sub-study. In GALAXI 1, which looked at change in the CDAI symptom score after 12 weeks, the three guselkumab groups showed average score reductions of approximately 144, 139, and 160 points respectively, while the placebo group showed an average reduction of about 34 points. In GALAXI 2 and GALAXI 3, two key combined outcomes were measured at weeks 12 and 48: first, the proportion of participants who had a meaningful symptom response early on and were then in remission (very low disease activity) by week 48; and second, the proportion who had that same early symptom response and also showed an improvement on bowel camera examination by week 48. In GALAXI 2, the reported figures for these two outcomes were 54.8% and 49.0% for the two guselkumab groups (compared with 11.8% for placebo) for the remission outcome, and 38.4% and 39.2% (compared with 5.3% for placebo) for the endoscopy outcome. In GALAXI 3, the corresponding figures were 48.0% and 46.9% (compared with 12.5% for placebo) for the remission outcome, and 36.0% and 33.6% (compared with 5.6% for placebo) for the endoscopy outcome. A separate regional result for GALAXI 2 reported that 47.1% of the combined guselkumab group had reached very low disease activity by week 12, compared with 22.4% in the placebo group. 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 42065683) ↗
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
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- You have been diagnosed with Crohn's disease (including a form that causes tunnels or passages called fistulas) for at least 3 months, affecting your colon, small intestine, or both, confirmed at some point by imaging, tissue samples, or a camera procedure
- Your Crohn's disease is considered moderate to severe, based on scores measuring symptoms like stool frequency, abdominal pain, and the appearance of your intestines during a camera examination
- Your blood or lab test results from the screening stage fall within the acceptable ranges set by the study
- If you are a woman who could become pregnant, you must have a negative pregnancy test at the start of the study
- You have either not responded well enough to standard Crohn's disease treatments or biologic medicines, or you were unable to tolerate them
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You have been diagnosed with ulcerative colitis or a form of colitis that doctors have not been able to clearly classify
- You have serious complications from Crohn's disease, such as significant narrowing of the intestine, short gut syndrome, or other related complications
- Your current Crohn's disease medications have not been at a stable dose recently
- You have recently received certain approved biologic treatments, experimental treatments, or procedures outside of the timeframes allowed by the study rules
- You have other health conditions that would make it unsafe for you to take part in the study (confirm with trial site)
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.
Trial contact details on record
Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 11 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12; Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48; Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48; Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48; Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48; Regional...
Other options
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.