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Blood test may end guesswork in Crohn's drug choice

NCT ID NCT07363044

Knowledge-focused Sponsor: Alimentiv Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a simple blood test that reads epigenetic markers can help doctors pick the best biologic drug (ustekinumab or vedolizumab) for adults with active Crohn's disease. 378 participants will be randomly assigned to either have their treatment guided by this test or by standard doctor choice. The goal is to see if the test leads to better remission and fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Epigenetic blood test (EpiPredict) to guide biologic selection (ustekinumab or vedolizumab)
What this could lead to
If successful, this test could help doctors pick the most effective biologic for each Crohn's patient, reducing trial-and-error and improving outcomes.
What could go wrong
This is an early-phase study with 378 participants, so results may not apply to everyone. The test may not reliably predict response, and some patients may still not respond to the chosen drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 378 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease (CD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Delta VZW

    RECRUITING

    Roeselare, Belgium

  • AZ Klina

    RECRUITING

    Brasschaat, Belgium

  • AZ Maria Middelares

    RECRUITING

    Ghent, Belgium

  • AZ Oostende

    RECRUITING

    Ostend, Belgium

  • AZ Sint Lucas

    RECRUITING

    Ghent, Belgium

  • Agostino Gemelli University Policlinic

    NOT_YET_RECRUITING

    Roma, Italy

  • Amsterdam UMC

    RECRUITING

    Amsterdam, Netherlands

  • Azienda Ospedaliero Universitaria Careggi Padiglione San Luca Nuovo

    RECRUITING

    Florence, Italy

  • CHU UCL Namur asbl Site Godinne

    RECRUITING

    Yvoir, Belgium

  • Cambridge University Hospitals NHS Trust

    RECRUITING

    Cambridge, United Kingdom

  • Cardiff & Vale UHB

    RECRUITING

    Llandough, United Kingdom

  • Centre Hospitalier Universitaire (CHU) de Liege

    RECRUITING

    Liège, Belgium

  • Elisabeth-TweeSteden Ziekenhuis (ETZ)

    RECRUITING

    Tilburg, Netherlands

  • Flevoziekenhuis Hospitaalweg 1

    NOT_YET_RECRUITING

    Almere Stad, Netherlands

  • GZA Antwerpen

    NOT_YET_RECRUITING

    Antwerp, Belgium

  • Groupe sante CHC/Clique du MontLegia

    RECRUITING

    Liège, Belgium

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

    RECRUITING

    London, United Kingdom

  • H.U.B. - Hôpital Erasme

    RECRUITING

    Brussels, Belgium

  • Hampshire Hospital NHS Foundation Trust

    RECRUITING

    Winchester, United Kingdom

  • Hull University Teaching Hospital NHS Trust

    RECRUITING

    Cottingham, United Kingdom

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

    NOT_YET_RECRUITING

    Castellana Grotte, Italy

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Italy

  • Imeldahospital

    RECRUITING

    Bonheiden, Belgium

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • Maastricht UMC

    RECRUITING

    Maastricht, Netherlands

  • Northern Care Alliance - Fairfield General Hospital

    RECRUITING

    Bury, United Kingdom

  • OLVG Oost

    RECRUITING

    Amsterdam, Netherlands

  • Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, United Kingdom

  • Radboudumc

    RECRUITING

    Nijmegen, Netherlands

  • San Camillo-Forlanini Hospital

    NOT_YET_RECRUITING

    Rome, Italy

  • The Dudley Group NHS Foundation Trust

    RECRUITING

    Dudley, United Kingdom

  • UKC Ljubljana

    NOT_YET_RECRUITING

    Ljubljana, Slovenia

  • UOC di Gastroenterologia ed Endoscopia Digestiva

    NOT_YET_RECRUITING

    San Giovanni Rotondo, Italy

  • UZ Ghent

    RECRUITING

    Ghent, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, Belgium

  • UZ Leuven Gasthuisberg

    RECRUITING

    Leuven, Belgium

  • Universitair Medisch Centrum Utrecht

    RECRUITING

    Utrecht, Netherlands

  • Universitair Ziekenhuis Antwerpen (UZA)

    RECRUITING

    Edegem, Belgium

  • University Hospital Southampton NHS Foundation Trust

    RECRUITING

    Southampton, United Kingdom

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