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Epigenetic‑guided versus usual care selection of vedolizumab or ustekinumab for adults with Crohn's disease

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

NA · Alimentiv Inc. · NCT07363044

This trial tests whether a blood epigenetic test that recommends either vedolizumab or ustekinumab helps adults with active Crohn's disease get better results than usual doctor-guided selection.

Quick facts

PhaseNA
Study typeInterventional
Enrollment378 (estimated)
Ages18 Years and up
SexAll
SponsorAlimentiv Inc. (other)
Drugs / interventionsmethotrexate, prednisone, Vedolizumab
Locations30 sites (Bonheiden and 29 other locations)
Trial IDNCT07363044 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label, randomized 1:1 trial enrolling 378 adults with active Crohn's disease to compare epigenome-guided biologic selection using the EpiPredict methylation assay against usual investigator-guided care. Participants are stratified by prior biologic use and baseline corticosteroid use, and peripheral blood samples will be analyzed by a machine-learning epigenetic biomarker that indicates the higher-probability responder between vedolizumab and ustekinumab. Sites will receive the single recommended biologic from the assay for the guided arm, while the control arm follows local standard-of-care selection; all dosing follows product labels and investigator discretion. The study will measure clinical efficacy, safety, and cost-effectiveness of using the epigenetic decision support compared with usual care.

Who should consider this trial

Good fit: Adults (≥18) with active Crohn's disease defined by HBI > 6 and endoscopic ulceration who are eligible to start vedolizumab and/or ustekinumab and meet local safety requirements for biologic therapy.

Not a fit: Patients with more than one prior biologic, those not eligible for vedolizumab or ustekinumab, those with only mild disease, or individuals unable to attend participating sites are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, the approach could help clinicians pick the biologic most likely to work up front, shortening time to remission and reducing exposure to ineffective therapies.

How similar studies have performed: Epigenetic and machine-learning biomarker–guided treatment is a relatively new approach with promising pilot data and biomarker-led strategies in IBD and other fields, but large randomized evidence for epigenetic-guided selection in Crohn's disease is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Bonheiden and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Crohn Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.