2024-519891-17-00Not yet recruitingPhase 2
Debut of Ulcerative Colitis: selective Top-down strategy - the DUCT trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Oct 2026
Brief summary (registry, in English)
Debut of Ulcerative Colitis: selective Top-down strategy - the DUCT trial. This is a proof-of-concept study to evaluate selective top-down treatment algorithm for a subgroup of patients with ulcerative colitis identified as probable severe 1-year outcome by a bio-signature. Positive bio-signature defined as mucosal TNF transcript ≥ 14100 copies/ug RNA and RHI ≥ 9. Hypothesis: For the most severe cases early biologic therapy (top-down) has a higher chance of achieving deep remission at one year after debut than the regular step-up regimen.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 2 Dec 2024
- Start date
- 1 Jan 2025
- Lead sponsor
- Universitetssykehuset Nord-Norge HF
- Diseases
- Ulcerative colitis
- EU CT number
- 2024-519891-17-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed ulcerative colitis. It tests early biologic treatment in people whose gut tissue tests show a higher chance of severe disease after 1 year.
- Age
- 18 to 65 years
- Sex
- Women and men can join.
- Disease stage
- Ulcerative colitis newly diagnosed, confirmed by colonoscopy and biopsy.
- Earlier treatment
- Cannot be on other biologic medicines at the same time.
- Biomarker or test result
- Positive bio-signature: mucosal TNF transcript ≥ 14100 copies/ug RNA and RHI ≥ 9.
Main reasons for not taking part
- Illness that rules out biologic therapy, such as cancer declared healed less than 5 years ago, tuberculosis, or untreated hepatitis B or C
- Fulminant colitis
- Severe infections such as sepsis, abscesses or opportunistic infections
- Moderate to severe heart failure (NYHA class III/IV)
- Pregnant or planning pregnancy during the study
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent treatment with other biologic agents, including anakinra and abatacept
- Participants who are required to recive live vaccines during the study period
Other illness
- Any condition that by standard clinical practice preclude the use of biologic therapy as per local guidelines, including but not exclusive: a. Malignancies declared healed less than 5 years earlier b. Evidence of ongoing or latent tuberculosis according to IGRA test, TB-SPOT or similar local testing practice c. Evidence of ongoing or latent untreated HBV or HCV infection
- Severe infections such as sepsis, abscesses or opportunistic infections
- Moderate to severe heart failure (NYHA class III/IV)
- Alternative diagnosis like C difficile or enteropathogenic infection likely to affect the clinical presentation
- Patients with multiple sclerosis or similar neurological/demyelinating conditions
Other
- Fulminant colitis
- Pregnant or planned pregnancy during the study period.
- Participation in other clinical trials or research studies that may interfere with the current study.
Who the study is looking for
- Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Participants who are newly diagnosed with ulcerative colitis (colonscopy and biopsy that confirm the diagnosis)
- Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Women with childbearing potential must use highly efficient contraception during and 6 months after the last infliximab administration
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitetssykehuset Nord-Norge HF | Tromsoe | Norway | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.