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

Sponsor: Alimentiv Inc.

NCT ID: NCT07363044

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Epigenome-Guided Treatment Arm (device), Investigator-Guided Treatment Arm (other)
How long the study runs
Study runs about 47 months (dates as stated)
About the drug or intervention
Epigenome-Guided Treatment Arm — device: 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. · Investigator-Guided Treatment Arm — other: Assigned to UST or VDZ per conventional SOC and without the use or knowledge of epigenome results.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at adults with active Crohn's disease. It compares choosing treatment based on epigenetic markers (signals in the body) with the usual way doctors choose standard treatment. The treatments involved are vedolizumab (VDZ) and/or ustekinumab (UST).

Who can take part

  • Aged 18 or over
  • Diagnosed Crohn's disease of the ileum, colon, or both, with active disease confirmed by symptom scores and a camera test
  • Able to receive vedolizumab and/or ustekinumab according to the drug labels and their doctor's opinion
  • Free from long-term or active infections such as HIV, tuberculosis, cytomegalovirus, hepatitis B and C, and C. difficile, following local checks
  • Not pregnant or breastfeeding, and agreeing to avoid pregnancy until Week 26 if applicable
  • If on non-biologic Crohn's medicines (like thiopurines or methotrexate), started at least 3 months ago and on a stable dose for at least 2 weeks
  • If on steroid tablets, on a stable dose within set limits for at least 2 weeks and willing to start reducing within 2 weeks of starting biologic treatment
  • Able to understand and follow the study requirements and give informed consent

Who may not be able to

  • Previous treatment with vedolizumab or ustekinumab
  • Previous treatment with more than one advanced therapy (biologic or advanced oral small molecule) for Crohn's disease
  • Crohn's complications that could interfere with the study, such as certain bowel surgeries, short bowel syndrome, ostomies, or problem strictures
  • Untreated abscesses in the abdomen or around the anus
  • Current or past ulcerative colitis, indeterminate colitis, microscopic colitis, or certain pre-cancerous cell changes in the colon
  • Higher risk of infection, such as recent serious infection or a weakened immune system, or past organ, bone marrow, or stem cell transplant
  • Rectal treatments for Crohn's within 2 weeks before the screening camera test
  • Regular use of NSAID painkillers (except celecoxib)
  • Faecal microbiota transplant within 4 weeks before randomisation
  • Major surgery within 8 weeks before randomisation or planned during the study
  • History of alcohol or drug misuse that could affect taking part
  • Other serious health problems that could affect safety or participation, such as cancer history or a reason not to receive the study biologics

What taking part involves

  • • Being assigned (by chance) to either treatment chosen using epigenetic markers or standard treatment selection
  • • Receiving biologic treatment with vedolizumab and/or ustekinumab
  • • Follow-up in the study at least up to Week 26

Time commitment: Not stated in full — the data mentions follow-up to Week 26, a baseline camera test, and pregnancy avoidance up to Week 26; ask the trial team about number of visits and total study duration.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
378
Started
2025-02-01
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for crohn disease (cd)
  • • NA - 378 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with crohn disease (cd)

Where?

  • • Bury - Northern Care Alliance - Fairfield General Hospital
  • • Cambridge - Cambridge University Hospitals NHS Trust
  • • Cottingham - Hull University Teaching Hospital NHS Trust
  • • Dudley - The Dudley Group NHS Foundation Trust
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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.

Crohn Disease (CD)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ initiated at least 3 months

What the study is looking for

  • ✓Participants must meet all of the following criteria for enrolment into the study:
  • ✓Aged 18 years or older at the time of agreement to take part.
  • ✓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...

Who cannot take part

  • ✗Participants who meet any of the following criteria are to be excluded from the study:
  • ✗Prior treatment with VDZ or UST.
  • ✗CD-related complications that in the opinion of the investigator would interfere with participation in the study,...
  • ✗Ileorectal anastomosis (rectum \< 15 cm), or a proctocolectomy.
  • ✗Short bowel syndrome.
See the full 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 Is This Study? (10 UK sites)

Northern Care Alliance - Fairfield General Hospital

Bury, United Kingdom

Recruiting
Site contact (verified)
Jimmy Limdi, DrPrincipal Investigator
Jimmy Limdi, Drjimmy.limdi@nca.nhs.uk

Cambridge University Hospitals NHS Trust

Cambridge, United Kingdom

Recruiting
Site contact (verified)
Sreedhar Subramanian, DrPrincipal Investigator
Sreedhar Subramanian, Drsreedhar.subramanian2@nhs.net

Hull University Teaching Hospital NHS Trust

Cottingham, United Kingdom

Recruiting
Site contact (verified)
Shaji Sebastian, DrPrincipal Investigator
Shaji Sebastian, DrShaji.sebastian4@nhs.net

The Dudley Group NHS Foundation Trust

Dudley, United Kingdom

Recruiting
Site contact (verified)
Shanika De Silva, DrPrincipal Investigator
Shanika De Silva, DrShanika.desilva@nhs.net

Cardiff & Vale UHB

Llandough, United Kingdom

Recruiting
Site contact (verified)
Dharmaraj Durai, DrPrincipal Investigator
Dharmaraj Durai, Drdharmaraj.durai@wales.nhs.uk

Guy's and St. Thomas' NHS Foundation Trust

London, United Kingdom

Recruiting
Site contact (verified)
Peter Irving, DrPrincipal Investigator
Peter Irving, Drpeter.irving@gstt.nhs.uk

King's College Hospital NHS Foundation Trust

London, United Kingdom

Recruiting
Site contact (verified)
Polychronis Pavlidis, DrPrincipal Investigator
Polychronis Pavlidis, Drppavlidis@nhs.net

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Recruiting
Site contact (verified)
Jack Satsangi, DrPrincipal Investigator

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Recruiting
Site contact (verified)
Fraser Cummings, DrPrincipal Investigator

Hampshire Hospital NHS Foundation Trust

Winchester, United Kingdom

Recruiting
Site contact (verified)
John Gordon, DrPrincipal Investigator

How to Get in Touch

Susan Archer

Sponsor contact

CONTACT

susan.archer@alimentiv.com

Lauren Schleicher

Sponsor contact

CONTACT

lauren.schleicher@alimentiv.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05