NCT07363044 A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 378 participants in total. It began in 2025-02-01 with a primary completion date of 2027-06.

Brief 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 Disease (CD).

Eligibility 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).

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