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 (NCT02743806) enrolled 331 participants, all of whom received vedolizumab 300 mg. The trial had a single treatment group and was primarily measuring the rates of adverse events (unexpected or unwanted medical occurrences during the study) and serious adverse events (those resulting in death, hospitalisation, lasting disability, or other significant medical consequences). Of the 331 people who started the trial, 150 completed it, while 181 did not complete it — the reasons for not completing were not detailed in the data provided here. The reported data shows that 61.9% of participants experienced at least one adverse event of any kind during the study, and 15.1% experienced at least one serious adverse event. The trial also tracked a separate category called "adverse events of special interest" — these were specific medical concerns the researchers were watching closely, including serious infections, certain types of cancer, liver injury, and reactions related to how the medication was given. The reported data shows that 3.9% of participants experienced one of these special-interest events. It is important to note that these figures describe events that were observed and recorded during the trial period — they do not on their own tell us whether vedolizumab caused these events, as adverse events can occur for many reasons unrelated to a study drug. No other outcome figures beyond these percentages were included in the submitted results 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 41684725) ↗
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 4 Crohn's Disease and Colitis Trial, Terminated
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 previously received vedolizumab (not a placebo or comparison drug) as part of an earlier qualifying clinical study.
- Your doctor believes you are still benefiting from vedolizumab and that continuing it is important, either because there is no similar alternative available to you, or because stopping treatment could cause your condition to get worse.
- If you are a man who is not sterilized and is sexually active with a woman who could become pregnant, you agree to use reliable contraception from the start of the study until 18 weeks after your last dose.
- If you are a woman who could become pregnant and are sexually active with a man who is not sterilized, you agree to use reliable contraception from the start of the study until 18 weeks after your last dose.
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.
- Vedolizumab is already available to you through normal commercial means, such as through insurance or other reimbursement programs.
- You have a medical condition or have had a previous treatment that your doctor believes would make it unsafe or unsuitable for you to participate in this study.
- If you are a woman who is currently pregnant, breastfeeding, or planning to become pregnant or donate eggs during the study or within 18 weeks after your last dose.
- If you are a man who plans to donate sperm during the study or within 18 weeks after your last dose.
- You have received a live vaccine in the past 18 weeks, or you will need a live vaccine during the study or within 18 weeks after your last dose.
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, 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 6 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 With Adverse Events (AEs) and Serious Adverse Events (SAEs); Percentage of Participants With Adverse Events of Special Interest (AESIs)
Other options
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.