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 aged 60 years or older at the time of screening.
- People who have been formally diagnosed with ulcerative colitis based on established medical guidelines (ECCO criteria).
- People whose ulcerative colitis has been in both clinical and endoscopic remission (meaning symptoms are controlled and the bowel lining looks healthy on camera) for at least 12 months, based on a standard scoring system (Mayo score ≤2, subscore ≤1).
- People who have been taking a thiopurine medication — either azathioprine or mercaptopurine — at a stable, effective dose for at least 60 months (5 years), with no dose changes in the last 12 months due to side effects.
- People who are also taking oral mesalazine, provided the dose has remained unchanged for at least 12 months.
- People who have been in clinical remission for at least 3 years without needing steroid tablets or injections, or any biological medicines — though topical rectal treatments and stable-dose oral mesalazine are permitted.
- People who have had a colonoscopy within the 6 months before the study starts, showing complete remission of the bowel lining (Mayo endoscopic score of 0).
- People who have had two stool (bowel motion) tests taken within one month of each other, both showing a calprotectin level below 150 mg/kg, confirming low inflammation in the bowel.
- People who are able and willing to provide written consent to participate in the trial.
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 whose ulcerative colitis has only ever affected the very end of the bowel (the rectum), with inflammation extending less than 25 cm at its furthest point throughout the entire history of the disease.
- People who have previously had surgery to remove the colon, or for whom surgery is considered urgently needed.
- People who have a surgically created internal pouch (ileoanal reservoir) connecting the small bowel to the anus.
- People with a history of serious or complicated disease around the anal area (perianal disease).
- People who cannot tolerate oral 5-ASA medications (such as mesalazine).
- People who have previously received or are currently receiving biologic therapies (such as anti-TNF medicines, vedolizumab, or ustekinumab) or JAK-inhibitor medications, for any medical condition.
- People with severely reduced kidney function, defined by specific blood test results showing high creatinine levels or very low kidney filtration rates (confirm with trial site for exact values).
- People with abnormal liver function blood test results at screening, where certain liver markers are more than twice the accepted upper normal range.
- People with abnormal blood count results at screening, including low levels of certain white blood cells, low platelet counts, or low haemoglobin (anaemia), based on specific measured thresholds (confirm with trial site for exact values).
- People with any other health condition that, in the treating doctor's judgment, could interfere with safe participation in 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.
Contact this trial
Principal Investigator: Margalida Calafat, MD, PhD, Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
Phone: +34 674682070
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
Primary endpoints
Biologic Relapse at 24 Months in Elderly UC Patients After Thiopurine Discontinuation
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.