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 (NCT02611817) looked at a medication called vedolizumab in people with Crohn's disease, a type of inflammatory bowel condition. A total of 644 people started an initial open treatment phase, all receiving vedolizumab given through a drip (intravenous infusion). Of those, 594 completed that phase. Participants who responded were then moved into a second, blinded phase — meaning neither they nor their doctors knew which treatment they were getting — where 135 people received a dummy (placebo) injection and 275 received vedolizumab as a self-administered injection under the skin. The trial was primarily measuring how many people reached what researchers called "clinical remission" (a low disease-activity score on a standard rating tool) by Week 52. The reported data shows that, for the main outcome at Week 52, 34.3% of participants in the placebo group and 48.0% in the vedolizumab injection group had scores low enough to be counted as being in clinical remission. For one of the secondary outcomes — a meaningful improvement in their disease score (a drop of at least 100 points on the rating scale) — the reported figures were 44.8% for the placebo group and 52.0% for the vedolizumab injection group. The trial also looked at how many people who were taking steroid tablets at the start were able to stop steroids and still be in remission by Week 52; the reported data shows 18.2% in the placebo group and 45.3% in the vedolizumab injection group met that measure. Finally, among participants who had never previously tried a type of medicine called a TNF-alpha antagonist (an older class of treatment for Crohn's disease), 42.9% in the placebo group and 48.6% in the vedolizumab injection group were reported to be in remission at Week 52. 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 38417060) ↗
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 were diagnosed with Crohn's disease (CD) at least 3 months before the study screening, confirmed by a camera examination of the gut and a tissue sample analysis.
- Your Crohn's disease is moderately to severely active, based on a specific scoring system (called CDAI, scored between 220 and 450), plus at least one of the following: a raised inflammation marker in your blood (CRP above 2.87 mg/L), a camera examination showing a certain number of ulcers in your gut, or a stool test showing high inflammation levels along with an imaging scan confirming ulcers.
- Your Crohn's disease affects your small intestine (ileum) and/or your large intestine (colon).
- Previous treatments for your Crohn's disease — such as steroids, immune-suppressing medicines, or TNF-blocking medicines — have not worked well enough, have stopped working, 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 a pocket of infection (abscess) in your abdomen found at screening.
- You have had a large portion or all of your large intestine surgically removed.
- You have had more than 3 surgeries to remove parts of your small intestine, or you have been diagnosed with short bowel syndrome.
- You have a stoma bag (ileostomy or colostomy) or a known, fixed, symptom-causing narrowing of your intestine.
- You have taken certain non-biological treatments for your condition (such as cyclosporine, tacrolimus, thalidomide, or tofacitinib) within roughly the last 30 days or longer before screening (confirm with trial site).
- You have taken any biological or biosimilar medication (lab-made treatments that target the immune system) within roughly the last 60 days or longer before screening (confirm with trial site).
- You have previously been treated with a medicine called vedolizumab.
- You are expected to need surgery for your Crohn's disease at any point during the study.
- You have colon polyps (growths) that have not been removed, or there are signs of abnormal cell changes in your colon lining.
- You have, or are suspected to have, another type of bowel condition such as ulcerative colitis or certain other forms of colitis.
- You currently have an active infection of any kind.
- You have a long-term hepatitis B or C infection, active or latent tuberculosis, or a condition that weakens your immune system (either from birth or developed later). Note: if you are immune to hepatitis B but not actively infected, you may still be eligible (confirm with trial site).
- You have a history of a serious neurological condition, such as a stroke, multiple sclerosis, a brain tumour, or a degenerative brain disease.
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: Medical Director Clinical Science, Takeda
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 9 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Percentage of Participants Achieving Clinical Remission at Week 52
Other options
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.