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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.
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
Conditions
Interventions
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.
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