Could older UC patients ditch risky meds for a simpler option?
NCT ID NCT07248644
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether older adults (60+) with ulcerative colitis who are in long-term remission can safely stop taking thiopurines (azathioprine or 6-mercaptopurine) and rely only on high-dose mesalazine. Thiopurines carry increased risks of infection and cancer with age, so switching may be safer. The trial will follow 304 participants for 24 months to compare relapse rates between those who stop thiopurines and those who continue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mesalazine (high-dose oral, ≥3 g/day) and thiopurines (azathioprine or 6-mercaptopurine)
- What this could lead to
- If successful, this could show that older patients with ulcerative colitis can safely switch to a simpler, lower-risk medication regimen without losing remission.
- What could go wrong
- This is a Phase 4 trial, so the drugs are already approved, but it is still possible that stopping thiopurines leads to more relapses. The study is also open-label, which may introduce bias.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 304 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients aged ≥60 years at screening. 2. Established diagnosis of ulcerative colitis according to ECCO criteria. 3. Clinical and endoscopic remission ≥12 months (Mayo score ≤2, subscore ≤1) according to clinical practice. 4. Treatment with a thiopurine (azathioprine 1-2.5 mg/kg/day or mercaptopurine 0.75-1.5 mg/kg/day) for ≥60 months. Treatment at stable doses (minimum effective dose without adverse events in the last 12 months. 5. In case of concomitant treatment with oral mesalazine, the dose must´ve been stable for ≥12 months. 6. Clinical remission (at the discretion of the investigator) for at least 3 years, without the need for treatment with oral or intravenous steroids or biological agents (topical rectal treatments are permitted as well as oral mesalazine if the dose has remained stable over the past 12 months). 7. Colonoscopy performed within 6 months prior to the start of the study in endoscopic remission (Mayo endoscopic index 0) according to clinical practice. 8. Two consecutive (centralised determinations in the period of one month) basal faecal calprotectin values \<150 mg/kg during screening. 9. Written informed consent. Exclusion Criteria: 1. Ulcerative proctitis (maximum observed extension \<25 cm throughout the course of the disease) 2. History of colectomy or imminent need for surgery. 3. Presence of ileoanal reservoir 4. History of complex perianal disease 5. Intolerance to oral 5-ASA treatment 6. Previous or concomitant biologic anti-TNF (vedolizumab, Ustekinumab) or JAK-inhibitor therapy for any condition. 7. Severe chronic renal insufficiency, defined as serum creatinine ≥ 2 mg/dL (estimated glomerular filtration rate ≤ 30 mL/min/1.73 m²). 8. Abnormal hepatic laboratory parameters, defined as AST, ALT, alkaline phosphatase, or GGT \> 2X the upper limit of normal (ULN) at screening. 9. Hematologic abnormalities at screening, defined as any of the following: absolute neutrophil count \< 1,500 cells/mm³, lymphocytes \< 500 cells/mm³, platelets \< 120,000 cells/mm³, or haemoglobin \< 12 g/dL (females) / \< 13 g/dL (males). 10. Any condition that in the investigator's opinion may compromise study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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