What is this study studying for Crohn's Disease?

This study is evaluating whether using epigenetic markers to guide the selection of biologic treatments can improve outcomes compared to standard treatment selection for active Crohn's Disease. It compares two biologic therapies, Vedolizumab and Ustekinumab, based on a machine-learning tool that predicts treatment response. The research is sponsored by Alimentiv Inc. and aims to improve personalized treatment choices for patients.

Who may be eligible for this Crohn's Disease clinical trial?

Adults aged 18 years or older with active Crohn's Disease involving the ileum or colon may be eligible. Participants must be able to receive Vedolizumab or Ustekinumab and follow study procedures. Those who have not previously been treated with these biologics and are not pregnant or breastfeeding are also eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this Crohn's Disease clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs related to their participation.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07363044

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

Led by Alimentiv Inc. · Updated on 2026-06-01

378

Participants Needed

Research Sites

82 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of epigenome-guided treatment selection compared to the usual standard-of-care SOC treatment for adults with active Crohns Disease CD. This study aims to assess the effectiveness, safety, and cost-effectiveness of using an epigenetic biomarker assay and machine-learning software called EpiPredict to help choose between two biologic therapies, Vedolizumab VDZ and Ustekinumab UST, for treating active CD. The trial includes participants who have active disease and are either new to biologic therapy or have had limited prior biologic exposure. Participants will be randomly assigned to one of two groups one group will receive biologic treatment guided by the EpiPredict software based on epigenetic blood tests, which indicates the likelihood of response to VDZ or UST, while the other group will receive biologic therapy following usual SOC without epigenetic guidance. Both groups will receive their biologic therapy according to approved product labels, with dose adjustments allowed as needed by the treating doctor. Treatment and assessments will be carried out over 26 weeks, with different assessment schedules depending on the biologic received. After this treatment period, participants will have long-term follow-up every six months up to 24 months. During the study, participants will provide blood samples for epigenetic testing and undergo clinical and endoscopic evaluations to monitor their disease activity and response to treatment. Data will also be collected from routine medical records and online questionnaires during follow-up visits. The primary measurement is the comparison of clinical remission and endoscopic response rates at Week 26 between the two treatment selection methods. Researchers will also evaluate cost-effectiveness and explore how well the epigenetic assay predicts treatment success. Participants are required to comply with study procedures and provide informed consent to participate fully.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Aged 18 years or older at the time of informed consent
Documented diagnosis of ileal, ileocolonic, or colonic Crohn's Disease
Active Crohn's Disease defined by HBI > 6 and SES-CD scores (≥6 for colitis/ileocolitis, ≥4 for ileitis only)
Eligible for Vedolizumab and/or Ustekinumab therapy per approved drug labels and physician opinion
Meet local standard-of-care criteria for biologic therapy initiation, including absence of chronic/opportunistic infections
Nonpregnant and nonlactating; agree to contraception and avoid pregnancy from consent until Week 26
Stable dose of nonbiologic inflammatory bowel disease therapies for at least 2 weeks; initiated at least 3 months prior
Oral corticosteroid dose up to prednisone 40 mg/day (or equivalent) stable for ≥2 weeks; willing to start taper within 2 weeks after biologic initiation
Able to understand and comply with study protocol and provide informed consent
Able to participate fully in all study aspects

You will not qualify if you...

Prior treatment with Vedolizumab or Ustekinumab
Prior treatment with more than one advanced therapy (biologic or oral small molecule) for Crohn's Disease
Crohn's Disease complications interfering with participation, such as ileorectal anastomosis, proctocolectomy, short bowel syndrome, ostomies, symptomatic strictures, untreated abscesses
History or current diagnosis of ulcerative colitis, indeterminate colitis, idiopathic colitis, microscopic colitis, or colonic mucosal dysplasia (except adenoma dysplasia)
Increased risk of infections due to recent pyogenic infection, immunodeficiency, or prior transplant
Use of topical rectal therapy for Crohn's Disease within 2 weeks before screening endoscopy
Chronic use of nonselective NSAIDs (except selective COX-2 inhibitors like celecoxib)
Faecal microbiota transplant within 4 weeks prior to randomization
Major surgery within 8 weeks prior to randomization or planned during study
History of excessive alcohol or drug abuse that may affect study compliance
Serious underlying diseases other than Crohn's Disease that may affect participation or safety, including malignancies, neurological disorders, unstable medical conditions, or contraindications to study biologics according to local prescribing information

Research Team

Susan Archer

Lauren Schleicher

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