MedTrace Logo

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

NCT07363044 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2026-01-23

No results posted yet for this study

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).

Conditions

  • Crohn Disease (CD)

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.

Sponsors & Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • Horizon Europe

    collaborator UNKNOWN

  • Stichting Amsterdam UMC

    collaborator UNKNOWN

  • Alimentiv Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2027-06-30
Completion
2029-01-31

Countries

  • Belgium
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07363044 on ClinicalTrials.gov