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Crohn Disease (CD)OMICROHNNCT07363044

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

A study testing Epigenome-Guided Treatment Arm and Investigator-Guided Treatment Arm in people with Crohn Disease (CD), run by Alimentiv Inc. at 39 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease (CD)
What is being tested?
Epigenome-Guided Treatment Arm and Investigator-Guided Treatment Arm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
378 participants
Where
39 sitesin 5 countries
Study dates
1 Feb 2025to Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria for enrolment into the study:
  • Aged 18 years or older at the time of informed consent.
  • Documented diagnosis of ileal, ileocolonic, or colonic CD (may be confirmed at baseline study endoscopy).
  • Active CD, as defined by HBI > 6 and SES-CD ≥ 6 for colitis/ileocolitis and ≥ 4 for ileitis only.
  • 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.
  • 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.
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  • 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.
  • 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.
  • 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.
  • In the opinion of the investigator, the participant is able to understand and comply with protocol requirements including treatment as assigned per the protocol.
  • 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

Who cannot join

  • Participants who meet any of the following criteria are to be excluded from the study:
  • Prior treatment with VDZ or UST.
  • 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.
  • 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.
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  • 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.
  • 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).
  • Increased risk of infectious complications (eg, recent pyogenic infection, any congenital or acquired immunodeficiency, or past organ, bone marrow, or stem cell transplantation).
  • Any topical rectal therapy for treatment of CD within 2 weeks prior to the screening endoscopy.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) as chronic treatment, except for cyclooxygenase-2logic selective NSAIDS (celecoxib).
  • Faecal microbiota transplant (includes human microbiota-based therapeutics) within 4 weeks prior to randomisation.
  • Any major surgery (in the investigator's opinion) performed within 8 weeks prior to randomisation or planned during the study.
  • 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.
  • 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).

Trial locations and contacts

39 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Susan Archer contact

susan.archer@alimentiv.com

Lauren Schleicher contact

lauren.schleicher@alimentiv.com

39 sites in 5 countries

Belgium15 sites, 15 recruiting

  • GZA Antwerpen

    Antwerp

    Filip Couturier, filip.couturier@gza.be

    Not yet recruiting

  • Imeldahospital

    Bonheiden

    Peter Bossuyt, Dr, Peter.bossuyt@imelda.be

    Recruiting

  • AZ Klina

    Brasschaat

    Evi Van Dyck, Dr, Evi.van.dyck@klina.be

    Evi Van Dyck, Dr

    Recruiting

  • H.U.B. - Hôpital Erasme

    Brussels

    Denis Franchimont, Dr, denis.franchimont@hubruxelles.be

    Denis Franchimont, Dr

    Recruiting

  • Universitair Ziekenhuis Antwerpen (UZA)

    Edegem

    Michael Somers, Dr, michael.somers@uza.be

    Michael Somers, Dr

    Recruiting

  • AZ Maria Middelares

    Ghent

    Nele Deprez, Dr, nele.deprez@mijnziekenhuis.be

    Nele Deprez, Dr

    Recruiting

  • AZ Sint Lucas

    Ghent

    Harold Peeters, Dr, harald.peeters@azstlucas.be

    Harold Peeters, Dr

    Recruiting

  • UZ Ghent

    Ghent

    Jeroen Geldof, Dr, jeroen.geldof@uzgent.be

    Jeroen Geldof, Dr

    Recruiting

  • UZ Leuven Gasthuisberg

    Leuven

    Bram Verstockt, bram.verstockt@uzleuven.be

    Recruiting

  • UZ Leuven

    Leuven

    Bram Verstockt, Dr, bram.verstockt@uzleuven.be

    Bram Verstockt, Dr

    Recruiting

  • Centre Hospitalier Universitaire (CHU) de Liege

    Liège

    Catharine Reenaers, Dr

    Catharine Reenaers, Dr

    Recruiting

  • Groupe sante CHC/Clique du MontLegia

    Liège

    Arnaud Colard, Dr, arnaud.colard@chc.be

    Arnaud Colard, Dr

    Recruiting

  • AZ Oostende

    Ostend

    Guy Lambrecht, Dr, glambrecht@azdamiaan.be

    Guy Lambrecht, Dr

    Recruiting

  • AZ Delta VZW

    Roeselare

    Filip Baert, Dr, filip.baert@azdelta.be

    Filip Baert, Dr

    Recruiting

  • CHU UCL Namur asbl Site Godinne

    Yvoir

    Jean-Francois Rahier, Dr, denis.franchimont@hubruxelles.be

    Jean-Francois Rahier, Dr

    Recruiting

Other trials in Belgium

United Kingdom10 sites, 10 recruiting

  • Northern Care Alliance - Fairfield General Hospital

    Bury

    Jimmy Limdi, Dr, jimmy.limdi@nca.nhs.uk

    Jimmy Limdi, Dr

    Recruiting

  • Cambridge University Hospitals NHS Trust

    Cambridge

    Sreedhar Subramanian, Dr, sreedhar.subramanian2@nhs.net

    Sreedhar Subramanian, Dr

    Recruiting

  • Hull University Teaching Hospital NHS Trust

    Cottingham

    Shaji Sebastian, Dr, Shaji.sebastian4@nhs.net

    Shaji Sebastian, Dr

    Recruiting

  • The Dudley Group NHS Foundation Trust

    Dudley

    Shanika De Silva, Dr, Shanika.desilva@nhs.net

    Shanika De Silva, Dr

    Recruiting

  • Cardiff & Vale UHB

    Llandough

    Dharmaraj Durai, Dr, dharmaraj.durai@wales.nhs.uk

    Dharmaraj Durai, Dr

    Recruiting

  • Guy's and St. Thomas' NHS Foundation Trust

    London

    Peter Irving, Dr, peter.irving@gstt.nhs.uk

    Peter Irving, Dr

    Recruiting

  • King's College Hospital NHS Foundation Trust

    London

    Polychronis Pavlidis, Dr, ppavlidis@nhs.net

    Polychronis Pavlidis, Dr

    Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford

    Jack Satsangi, Dr, jack.satsangi@ndm.ox.ac.uk

    Jack Satsangi, Dr

    Recruiting

  • University Hospital Southampton NHS Foundation Trust

    Southampton

    Fraser Cummings, Dr

    Fraser Cummings, Dr

    Recruiting

  • Hampshire Hospital NHS Foundation Trust

    Winchester

    John Gordon, Dr, john.gordon@hhft.nhs.uk

    John Gordon, Dr

    Recruiting

Other trials in United Kingdom

Netherlands7 sites, 7 recruiting

  • Flevoziekenhuis Hospitaalweg 1

    Almere Stad

    Marco Mundt, MMundt@flevoziekenhuis.nl

    Not yet recruiting

  • Amsterdam UMC

    Amsterdam

    Krisztina Gecse, Dr, k.b.gecse@amsterdamumc.nl

    Krisztina Gecse, Dr

    Recruiting

  • OLVG Oost

    Amsterdam

    Margien Seinen, Dr, m.l.seinen@olvg.nl

    Margien Seinen, Dr

    Recruiting

  • Maastricht UMC

    Maastricht

    Zlatan Majagic, Dr, zlatan.mujagic@mumc.nl

    Zlatan Majagic, Dr

    Recruiting

  • Radboudumc

    Nijmegen

    Marjolijn Duijvestein, Dr, Marjolijn.Duijvestein@radboudumc.nl

    Marjolijn Duijvestein, Dr

    Recruiting

  • Elisabeth-TweeSteden Ziekenhuis (ETZ)

    Tilburg

    Maurice Lutgens, Dr, m.lutgens@etz.nl

    Maurice Lutgens, Dr

    Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht

    Bas Oldenburg, Dr, b.oldenburg@umcutrecht.nl

    Bas Oldenburg, Dr

    Recruiting

Other trials in Netherlands

Italy6 sites, 6 recruiting

  • IRCCS "Saverio de Bellis", National Institute of Gastroenterology

    Castellana Grotte

    Mauro Mastronardi, mauro21mastronardi@gmail.com

    Not yet recruiting

  • Azienda Ospedaliero Universitaria Careggi Padiglione San Luca Nuovo

    Florence

    Gabriele Dragoni, gabrieledragoni89@gmail.com

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan

    Silvio Danese, Dr, ibd.trials@hsr.it

    Silvio Danese, Dr

    Recruiting

  • Agostino Gemelli University Policlinic

    Roma

    Franco Scaldaferri, francoscaldaferri@gmail.com

    Not yet recruiting

  • San Camillo-Forlanini Hospital

    Rome

    Rocco Cosintino, rcosintino@scamilloforlanini.rm.it

    Not yet recruiting

  • UOC di Gastroenterologia ed Endoscopia Digestiva

    San Giovanni Rotondo

    Fabrizio Bossa, f.bossa@operapadrepio.it

    Not yet recruiting

Other trials in Italy

Slovenia1 site, 1 recruiting

  • UKC Ljubljana

    Ljubljana

    David Drobne, david.drobne@gmail.com

    Not yet recruiting

Other trials in Slovenia

About this study

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).

Read the 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.

Being tested
Epigenome-Guided Treatment Arm, Investigator-Guided Treatment Arm
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epigenome-Guided Treatment ArmDevice

    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 ArmOther

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

Study groups in NCT07363044
Study groupRoleWhat they receive
Investigator-Guided Treatment ArmOtherNot described
Receives: Other: Investigator-Guided Treatment Arm
Epigenome-Guided Treatment ArmExperimentalNot described
Receives: Device: Epigenome-Guided Treatment Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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])

    Measured: Baseline to Week 26

Secondary outcomes (3)

  1. To explore the optimal threshold of EpiPredict results in predicting treatment response using data from participants assigned to the epigenome-guided treatment selection group

    Receiver-operating characteristic curve area analysis will be used Predicted likelihood of success of reaching corticosteroid-free clinical remission and endoscopic response

    Measured: Baseline to Week 26

  2. 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

    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)

    Measured: Baseline to Week 26

  3. To evaluate the cost-effectiveness of epigenome-guided treatment selection compared to usual SOC treatment selection

    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

    Measured: Baseline to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start1 Feb 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
378 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07363044
Sponsor's protocol ID
RCT-01727
Acronym
OMICROHN
Status last verified
May 2026
First submitted
15 Jan 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Epigenome-Guided Treatment Arm and Investigator-Guided Treatment Arm in people with Crohn Disease (CD), run by Alimentiv Inc. at 39 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Belgium, United Kingdom, Netherlands, Italy, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Susan Archer (susan.archer@alimentiv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07363044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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