Debut of Ulcerative Colitis: selective Top-down strategy - the DUCT trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitetssykehuset Nord-Norge HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2025-06-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

University Hospital of North-Norway

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Conditions and MedDRA coding

Ulcerative colitis

Regulatory references

Plan to share IPD

No

IPD plan description

We are collecting anonymized data in the REDCap system, and the data will be stored securely at the Research Department at the University Hospital of North Norway. A key file will be used, which will be destroyed upon the project’s completion.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
2. Participants who are newly diagnosed with ulcerative colitis (colonscopy and biopsy that confirm the diagnosis)
3. 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
4. Women with childbearing potential must use highly efficient contraception during and 5 months after the last adalimumab administration

Exclusion criteria 8

1. 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
2. Fulminant colitis
3. Severe infections such as sepsis, abscesses or opportunistic infections
4. Moderate to severe heart failure (NYHA class III/IV)
5. Alternative diagnosis like C difficile or enteropathogenic infection likely to affect the clinical presentation
6. Pregnant or planned pregnancy during the study period.
7. Participation in other clinical trials or research studies that may interfere with the current study.
8. Participants who are required to recive live vaccines during the study period

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Primary outcome Main Study: Percentage of patients in deep remission 1 year after debut (defined as Mayo score ≤2, endoscopic Mayo score =0, and RHI <3.
2. Sub-study: Percentage of patients who starts with biological medication or undergo surgical intervention during det first year after debut of disease

Secondary endpoints 3

1. Secondary outcomes: Patient reported outcomes (IBD-QoL, SCCAI), evaluate change in scores from baseline. Medical expenditures based on retrospective questionnaire and medical records review.
2. Secondary endpoint: Patient reported outcomes (IBD-QoL, SCCAI), evaluate change in scores from baseline. Medical expenditures based on retrospective questionnaire and medical records review after 3 years.
3. Exploratory outcomes: Improvement of the proposed biosignature based on data from all 200 included subjects.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitetssykehuset Nord-Norge HF

Sponsor organisation

Universitetssykehuset Nord-Norge HF

Address

Hansine Hansens Veg 67

City

Tromsoe

Postcode

9019

Country

Norway

Scientific contact point

Organisation

Universitetssykehuset Nord-Norge HF

Contact name

Rasmus Goll

Public contact point

Organisation

Universitetssykehuset Nord-Norge HF

Contact name

Rasmus Goll

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications