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

May 28, 2026 updated by: Alimentiv Inc.
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial will include 378 participants with active CD, defined as an HBI > 6 and the presence of endoscopic ulceration. Approximately 50% of the enrolled population will be bio-naïve and 50% exposed to no more than 1 prior biologic.

Eligible participants will be randomised 1:1 to either epigenome-guided treatment selection or usual SOC treatment selection. Randomization will be stratified by prior biologic use (yes/no) and corticosteroid use (yes/no) at baseline.

Blood samples for the assessment will be collected for all participants during screening. Peripheral blood will be tested via a machine-learning-powered epigenetic biomarker assay. EpiPredict is a software designed for CSV file input, data transfer, storage, and display, and will be serving as a EpiPredict clinical decision support system. It recommends treatment selections for 2 biologics (Vedolizumab (VDZ) and Vedolizumab (UST)) for CD utilizing genetic data.

The intervention (EpiPredict software) will indicate the probability of response to both VDZ and UST (though sites will only be provided with the treatment with the highest outcome) for the treatment of CD using a hybrid capture-based methylation assay (approved for research use only) and the EpiPredict software.

All participants in the study will be administered their biologic therapy in accordance with the product label and local SOC recommendations. Dose adjustments will be allowed in both groups at the treating investigator's discretion.

During the 26-week treatment period, the study assessments will follow the SOC regimen of the assigned biologic treatment. For participants receiving VDZ, study assessments are to occur at Weeks 6, 14, and 26; for participants receiving UST, study assessments are to occur at Weeks 8, 16, and 26.

Long-term follow up assessments are to occur every 6 months (Months 12, 18, and 24) after Week 26. Data for long-term follow up assessments will be collected from the participant's medical records captured at routine SOC visits and online questionnaires.

Study Type

Interventional

Enrollment (Estimated)

378

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Antwerp, Belgium
      • Bonheiden, Belgium
      • Brasschaat, Belgium
        • Recruiting
        • AZ Klina
        • Contact:
        • Principal Investigator:
          • Evi Van Dyck, Dr
      • Brussels, Belgium
      • Edegem, Belgium
        • Recruiting
        • Universitair Ziekenhuis Antwerpen (Uza)
        • Contact:
        • Principal Investigator:
          • Michael Somers, Dr
      • Ghent, Belgium
      • Ghent, Belgium
        • Recruiting
        • UZ Ghent
        • Contact:
        • Principal Investigator:
          • Jeroen Geldof, Dr
      • Ghent, Belgium
      • Leuven, Belgium
      • Leuven, Belgium
      • Liège, Belgium
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Liege
        • Contact:
          • Catharine Reenaers, Dr
        • Principal Investigator:
          • Catharine Reenaers, Dr
      • Liège, Belgium
        • Recruiting
        • Groupe sante CHC/Clique du MontLegia
        • Contact:
        • Principal Investigator:
          • Arnaud Colard, Dr
      • Ostend, Belgium
        • Recruiting
        • AZ Oostende
        • Contact:
        • Principal Investigator:
          • Guy Lambrecht, Dr
      • Roeselare, Belgium
        • Recruiting
        • AZ Delta VZW
        • Contact:
        • Principal Investigator:
          • Filip Baert, Dr
      • Yvoir, Belgium
        • Recruiting
        • CHU UCL Namur asbl Site Godinne
        • Contact:
        • Principal Investigator:
          • Jean-Francois Rahier, Dr
  • Italy
      • Castellana Grotte, Italy
        • Not yet recruiting
        • IRCCS "Saverio de Bellis", National Institute of Gastroenterology
        • Contact:
      • Florence, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Careggi Padiglione San Luca Nuovo
        • Contact:
      • Milan, Italy
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
        • Principal Investigator:
          • Silvio Danese, Dr
      • Roma, Italy
      • Rome, Italy
      • San Giovanni Rotondo, Italy
        • Not yet recruiting
        • UOC di Gastroenterologia ed Endoscopia Digestiva
        • Contact:
  • Netherlands
      • Almere Stad, Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam UMC
        • Contact:
        • Principal Investigator:
          • Krisztina Gecse, Dr
      • Amsterdam, Netherlands
        • Recruiting
        • OLVG Oost
        • Contact:
        • Principal Investigator:
          • Margien Seinen, Dr
      • Maastricht, Netherlands
        • Recruiting
        • Maastricht UMC
        • Contact:
        • Principal Investigator:
          • Zlatan Majagic, Dr
      • Nijmegen, Netherlands
      • Tilburg, Netherlands
        • Recruiting
        • Elisabeth-TweeSteden Ziekenhuis (ETZ)
        • Contact:
        • Principal Investigator:
          • Maurice Lutgens, Dr
      • Utrecht, Netherlands
        • Recruiting
        • Universitair Medisch Centrum Utrecht
        • Contact:
        • Principal Investigator:
          • Bas Oldenburg, Dr
  • Slovenia
  • United Kingdom
      • Bury, United Kingdom
        • Recruiting
        • Northern Care Alliance - Fairfield General Hospital
        • Contact:
        • Principal Investigator:
          • Jimmy Limdi, Dr
      • Cambridge, United Kingdom
        • Recruiting
        • Cambridge University Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Sreedhar Subramanian, Dr
      • Cottingham, United Kingdom
        • Recruiting
        • Hull University Teaching Hospital NHS Trust
        • Contact:
        • Principal Investigator:
          • Shaji Sebastian, Dr
      • Dudley, United Kingdom
        • Recruiting
        • The Dudley Group NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Shanika De Silva, Dr
      • Llandough, United Kingdom
        • Recruiting
        • Cardiff & Vale UHB
        • Contact:
        • Principal Investigator:
          • Dharmaraj Durai, Dr
      • London, United Kingdom
        • Recruiting
        • King's College Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Polychronis Pavlidis, Dr
      • London, United Kingdom
        • Recruiting
        • Guy's and St. Thomas' NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Peter Irving, Dr
      • Oxford, United Kingdom
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Jack Satsangi, Dr
      • Southampton, United Kingdom
        • Recruiting
        • University Hospital Southampton NHS Foundation Trust
        • Contact:
          • Fraser Cummings, Dr
        • Principal Investigator:
          • Fraser Cummings, Dr
      • Winchester, United Kingdom
        • Recruiting
        • Hampshire Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • John Gordon, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet all of the following criteria for enrolment into the study:

  1. Aged 18 years or older at the time of informed consent.
  2. Documented diagnosis of ileal, ileocolonic, or colonic CD (may be confirmed at baseline study endoscopy).
  3. Active CD, as defined by HBI > 6 and SES-CD ≥ 6 for colitis/ileocolitis and ≥ 4 for ileitis only.
  4. Eligible to receive either VDZ and/or UST therapy for the treatment of CD per the approved drug label requirements and in the opinion of the treating physician.
  5. Must meet all eligibility criteria for biologic therapy initiation as per local SOC, including absence of chronic/opportunistic infections as demonstrated by local protocols for human immunodeficiency virus, tuberculosis, active cytomegalovirus, hepatitis B and C, and Clostridioides difficile infection. Local vaccination protocols apply as per SOC.
  6. Nonpregnant and nonlactating. Participants of childbearing potential must agree to follow local SOC guidelines for use of biologics in pregnancy/lactation, including appropriate contraception, during the study; must agree to avoid becoming pregnant from the time of informed consent up until Week 26.
  7. If receiving nonbiologic therapies for inflammatory bowel disease, including thiopurines and methotrexate, must have initiated at least 3 months prior to screening and must be on a stable dose for at least 2 weeks prior to screening.

  8. If receiving oral corticosteroids, the participant is eligible if they meet all the following criteria:

    • The dose is up to a maximum of prednisone ≤ 40 mg/day or budesonide ≤ 9 mg/day or equivalent.
    • The dose has been stable for ≥ 2 weeks prior to screening.
    • The participant is willing to initiate a corticosteroid taper within 2 weeks after initiating biologic treatment.
  9. In the opinion of the investigator, the participant is able to understand and comply with protocol requirements including treatment as assigned per the protocol.
  10. Able to participate fully in all aspects of this clinical study. Full comprehension of consent language and informed consent must be obtained from the participant, or the participant's legally acceptable representative, and documented

Exclusion Criteria:

Participants who meet any of the following criteria are to be excluded from the study:

  1. Prior treatment with VDZ or UST.
  2. Prior treatment with more than 1 advanced therapy (eg, any biologic [ie, anti- tumour necrosis factor (TNF), anti-interleukin, anti-integrin]) or advanced oral small molecule [ie, Janus kinase inhibitor]) for CD.

  3. CD-related complications that in the opinion of the investigator would interfere with participation in the study, including but not limited to:

    • Ileorectal anastomosis (rectum < 15 cm), or a proctocolectomy.
    • Short bowel syndrome.
    • All ostomies.
    • Symptomatic strictures in the bowel or symptomatic strictures in the ileum or ileocecal valve that have a stenosis.
    • Suspected or diagnosed active intra-abdominal or perianal abscess that have not been appropriately treated.
  4. History or current diagnosis of ulcerative colitis (unless this diagnosis was made erroneously), indeterminate colitis, idiopathic colitis (ie, colitis not consistent with CD), microscopic colitis, or colonic mucosal dysplasia (excluding dysplasia in resected adenomas).
  5. Increased risk of infectious complications (eg, recent pyogenic infection, any congenital or acquired immunodeficiency, or past organ, bone marrow, or stem cell transplantation).
  6. Any topical rectal therapy for treatment of CD within 2 weeks prior to the screening endoscopy.
  7. Nonsteroidal anti-inflammatory drugs (NSAIDs) as chronic treatment, except for cyclooxygenase-2logic selective NSAIDS (celecoxib).
  8. Faecal microbiota transplant (includes human microbiota-based therapeutics) within 4 weeks prior to randomisation.
  9. Any major surgery (in the investigator's opinion) performed within 8 weeks prior to randomisation or planned during the study.
  10. History of excessive alcohol or drug abuse that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.
  11. Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study or would compromise participant safety (such as history of malignancies, major neurological disorders, any unstable or uncontrolled medical disorder, or any known or suspected contraindication to any of the study biologics according to local prescribing information).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Investigator-Guided Treatment Arm
Other: Investigator-Guided Treatment Arm
Assigned to UST or VDZ per conventional SOC and without the use or knowledge of epigenome results.
Experimental: Epigenome-Guided Treatment Arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the efficacy of epigenome-guided treatment selection to usual SOC treatment selection for inducing clinical remission and endoscopic response at Week 26 in participants with active CD.
Time Frame: Baseline to Week 26
Corticosteroid-free clinical remission (Harvey-Bradshaw Index [HBI] score ≤ 4) and endoscopic response (≥ 50% decrease from baseline in the Simple Endoscopic Score for Crohn's Disease [SES-CD])
Baseline to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To explore the optimal threshold of EpiPredict results in predicting treatment response using data from participants assigned to the epigenome-guided treatment selection group
Time Frame: Baseline to Week 26
Receiver-operating characteristic curve area analysis will be used Predicted likelihood of success of reaching corticosteroid-free clinical remission and endoscopic response
Baseline to Week 26
To compare the efficacy of epigenome-guided treatment selection to usual SOC treatment selection for improving clinical and endoscopic outcome measures at Week 26 in participants with active CD
Time Frame: Baseline to Week 26
Endoscopic response (≥ 50% decrease from baseline in SES-CD score) Endoscopic remission (SES-CD ≤ 3) Clinical remission (HBI ≤ 4) Corticosteroid-free clinical remission Clinical response (decrease in HBI ≥ 3 points from baseline) Corticosteroid-free deep remission (HBI ≤ 4 and SES-CD ≤ 3)
Baseline to Week 26
To evaluate the cost-effectiveness of epigenome-guided treatment selection compared to usual SOC treatment selection
Time Frame: Baseline to 24 Months
Societal costs as measured by the modified iMTA Medical Cost Questionnaire and modified iMTA Productivity Cost Questionnaire questionnaires Quality of life-years as measured by the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) questionnaire
Baseline to 24 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the safety of a treatment based on epigenome-guided treatment selection compared to usual SOC treatment selection
Time Frame: Baseline to Week 26
Adverse events CD-related complications, hospitalisations, and/or surgeries
Baseline to Week 26
To explore additional efficacy measures of epigenome-guided treatment selection compared to usual SOC treatment selection at Week 26 in participants with active CD.
Time Frame: Baseline to Week 26
Achieving a minimally clinically important difference in patient-reported health-related quality of life (HRQOL) compared to baseline as measured by the EQ-5D-5L Clinical remission (HBI ≤ 4) Clinical response (decrease in HBI ≥ 3 points from baseline) Clinical remission (Crohn's Disease Activity Index [CDAI] score of < 150) over time Time to symptomatic remission (HBI ≤ 4) No drainage on gentle finger compression in participants with draining fistulas Extra-intestinal manifestations Histologic response, as defined in the statistical analysis plan (SAP) Histologic remission, as defined in the SAP Whether the participant achieved 25%, 50%, and 75% reduction from baseline in the Robarts Histopathology Index (RHI) score Serum trough concentrations of biologic drug Biochemical remission CRP ≤ 5.0 mg/L and/or fecal calprotectin [FC] < 250 µg/g) Change in the Symptoms and Impact Questionnaire-CD (SIQ-CD) score
Baseline to Week 26
In a subset (~30%) of participants, to evaluate response by intestinal ultrasound (IUS) in participants assigned to epigenome-guided treatment selection compared to usual SOC treatment selection
Time Frame: Baseline to Week 26
Proportion of participants with IUS response (defined as by reduction in bowel wall thickness [BWT > 25%] or [> 2.0 mm] or [> 1.0 mm and one colour Doppler signal (CDS) reduction]) Proportion of participants with transmural remission (defined by BWT ≤ 3 mm and normal/0 CDS) Proportion of participants with transmural remission and endoscopic remission
Baseline to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alimentiv Inc.

Collaborators

The Leona M. and Harry B. Helmsley Charitable Trust
Horizon Europe
Stichting Amsterdam UMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT-01727

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn Disease (CD)

Clinical Trials on Investigator-Guided Treatment Arm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe