NCT07363044 A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease
| NCT ID | NCT07363044 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alimentiv Inc. |
| Condition | Crohn Disease (CD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 378 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-06 |
Trial Parameters
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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 guidel