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 (NCT03107793) enrolled 498 people with Crohn's disease, who all received an intravenous infusion of a medicine called ustekinumab at the start of the study. After that initial 16-week period, participants were randomly assigned to one of two approaches for the next 32 weeks (up to Week 48): a "treat to target" group (219 people), where treatment decisions were guided by regular internal camera examinations of the bowel (endoscopies), or a "routine care" group (221 people), where treatment was managed in the usual clinical way without those scheduled endoscopy targets. A further extension period ran to Week 104 for those who continued. The trial was primarily measuring how many participants showed a meaningful improvement on camera examination of their bowel — specifically, at least a 50% reduction in a bowel inflammation score — by Week 48. The reported data shows that for the main outcome at Week 48, 37.9% of participants in the treat-to-target group and 29.9% in the routine care group showed that level of improvement on camera examination. Several additional measures were also reported. When looking at symptom-based scores (using a tool called the Crohn's Disease Activity Index, which runs from 0 to around 600, with higher numbers meaning more active disease), the reported data shows that at Week 48, around 68.0% of the treat-to-target group and 77.8% of the routine care group met the threshold for a meaningful symptom response; and around 61.6% versus 69.7% respectively were recorded as being in symptom remission (a score below 150). For bowel camera remission — defined as a very low inflammation score of 2 or under — the reported figures at Week 48 were 11.4% for the treat-to-target group; the corresponding figure for the routine care group at that specific time point was not reported in the submitted data. 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 40357993) ↗
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, Completed
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 active, moderate to severe Crohn's disease affecting the small intestine and/or colon, confirmed by a symptom score and a camera examination (endoscopy) showing signs of active disease
- Previous treatments for Crohn's disease either did not work well enough, stopped working, caused side effects you could not tolerate, or were not suitable for you — this applies to either standard (conventional) treatments or one previous biologic medication
- You have been screened and cleared for tuberculosis (TB) infection
- You are willing and able to sign a consent form agreeing to take part in the study
For the optional sub-study (in addition to the above):
- You are already enrolled in the main study at a site that offers the sub-study
- You are willing to sign a separate consent form for the sub-study
- You meet all the main study requirements
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 serious complications from Crohn's disease, such as significant blockages in the bowel, short gut syndrome, or other issues that may require surgery or make it hard to measure how well treatment is working
- You currently have, or are suspected to have, an abscess (a pocket of infection) — though recently drained skin or anal abscesses treated at least 3 weeks ago, or internal abscesses treated at least 8 weeks ago, may be acceptable (confirm with trial site)
- You have had bowel surgery within the last 6 months
- You have a working stoma or ostomy bag
- You have already been treated with more than one biologic medication for Crohn's disease
For the optional sub-study:
- Your body size or other physical characteristics make it unlikely that an abdominal ultrasound scan would give a clear picture of the affected bowel (confirm with trial site)
- Your bowel wall appears normal in thickness on ultrasound at the start of the study
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.
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, and they are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Percentage of Participants With Endoscopic Response at Week 48
Other options
Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.