Phase 4 Crohn's Disease and Colitis Trial, Not Yet 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
- People who have been diagnosed with ulcerative colitis or Crohn's disease at least 3 months before joining the trial, based on standard recognised diagnostic criteria.
- People aged 18 or older.
- People who have been on a stable dose of vedolizumab (VDZ) or ustekinumab (UST) for at least 3 months before joining the trial.
- People whose disease is stable or only mildly active, based on specific stool and symptom score measurements (confirm with trial site).
- People whose medications have not changed in the 3 months before joining — noting that certain other immune-suppressing or anti-inflammatory medications taken alongside VDZ or UST are permitted (confirm with trial site).
- People who are able to understand the patient information materials provided.
- People who are able to give written informed consent.
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.
- People diagnosed with indeterminate colitis (a type of bowel condition that cannot be clearly classified).
- People who have a stoma or pouch.
- People whose primary reason for being on VDZ or UST is to treat fistulas (abnormal tunnels between body parts caused by the disease).
- People whose treating doctor expects their medication will need to change soon.
- People who are expected to need surgery within the next 3 months.
- People for whom continuing VDZ or UST is medically unsuitable, including those who have previously had an infusion reaction to either medication.
- People who have an active infection requiring intravenous treatment, or a known diagnosis of tuberculosis, HIV, or hepatitis.
- People who have any other condition that the responsible doctor considers incompatible with taking part in the study.
- People who are unable to take part in recording symptom scores.
- People who are pregnant or breastfeeding at the time of joining the trial.
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: Mark A Ainsworth, professor, DMSc, Odense University Hospital
Phone: +45 22 56 72 57
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
Primary endpoints
The fraction of patients in steroid-free remission
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.