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RECRUITING
NCT07363044
NA

A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease

Sponsor: Alimentiv Inc.

View on ClinicalTrials.gov

Summary

This is a multicentre, prospective, randomised, controlled, open-label study to assess the efficacy, safety, and cost-effectiveness of epigenome-guided treatment selection compared to usual standard-of-care (SOC) treatment selection in patients initiating biologic therapy for the treatment of their active Crohn's Disease (CD).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

378

Start Date

2025-02-01

Completion Date

2029-01

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

DEVICE

Epigenome-Guided Treatment Arm

Participants will receive UST or VDZ biologic therapy as indicated by an epigenome read-out of peripheral blood using a hybrid capture-based methylation assay. The assay and EpiPredict software will indicate the probability of response to VDZ and UST. The biologic with the predicted highest likelihood of success will be communicated to the investigator and the biologic initiated using standard dosing regimens.

OTHER

Investigator-Guided Treatment Arm

Assigned to UST or VDZ per conventional SOC and without the use or knowledge of epigenome results.

Locations (30)

Imeldahospital

Bonheiden, Belgium

AZ Klina

Brasschaat, Belgium

H.U.B. - Hôpital Erasme

Brussels, Belgium

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Belgium

AZ Maria Middelares

Ghent, Belgium

AZ Sint Lucas

Ghent, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Centre Hospitalier Universitaire (CHU) de Liege

Liège, Belgium

Groupe sante CHC/Clique du MontLegia

Liège, Belgium

AZ Oostende

Ostend, Belgium

AZ Delta VZW

Roeselare, Belgium

CHU UCL Namur asbl Site Godinne

Yvoir, Belgium

IRCCS Ospedale San Raffaele

Milan, Italy

Amsterdam UMC

Amsterdam, Netherlands

OLVG Oost

Amsterdam, Netherlands

Maastricht UMC

Maastricht, Netherlands

Radboudumc

Nijmegen, Netherlands

Elisabeth-TweeSteden Ziekenhuis (ETZ)

Tilburg, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Northern Care Alliance - Fairfield General Hospital

Bury, United Kingdom

Cambridge University Hospitals NHS Trust

Cambridge, United Kingdom

Hull University Teaching Hospital NHS Trust

Cottingham, United Kingdom

The Dudley Group NHS Foundation Trust

Dudley, United Kingdom

Cardiff & Vale UHB

Llandough, United Kingdom

Guy's and St. Thomas' NHS Foundation Trust

London, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Hampshire Hospital NHS Foundation Trust

Winchester, United Kingdom