Actively Recruiting
A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease
Led by Alimentiv Inc. · Updated on 2026-06-01
378
Participants Needed
39
Research Sites
82 weeks
Total Duration
On this page
Sponsors
A
Alimentiv Inc.
Lead Sponsor
T
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborating Sponsor
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 Crohn's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive biologic therapy with either Vedolizumab or Ustekinumab, selected by epigenome-guided treatment or standard of care. Study assessments follow the assigned biologic's routine schedule.
3 visits during treatment: Weeks 6, 14, and 26 for Vedolizumab; Weeks 8, 16, and 26 for Ustekinumab
Duration - Up to 18 months after treatment
Participants are followed for long-term outcomes with assessments collected from routine medical records and online questionnaires.
Visits every 6 months at Months 12, 18, and 24
Trial Site Locations
Total: 39 locations
1
GZA Antwerpen
Antwerp, Belgium
Not Yet Recruiting
2
Imeldahospital
Bonheiden, Belgium
Actively Recruiting
3
AZ Klina
Brasschaat, Belgium
Actively Recruiting
4
H.U.B. - Hôpital Erasme
Brussels, Belgium
Actively Recruiting
5
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Belgium
Actively Recruiting
6
AZ Maria Middelares
Ghent, Belgium
Actively Recruiting
7
AZ Sint Lucas
Ghent, Belgium
Actively Recruiting
8
UZ Ghent
Ghent, Belgium
Actively Recruiting
9
UZ Leuven Gasthuisberg
Leuven, Belgium
Actively Recruiting
10
UZ Leuven
Leuven, Belgium
Actively Recruiting
11
Centre Hospitalier Universitaire (CHU) de Liege
Liège, Belgium
Actively Recruiting
12
Groupe sante CHC/Clique du MontLegia
Liège, Belgium
Actively Recruiting
13
AZ Oostende
Ostend, Belgium
Actively Recruiting
14
AZ Delta VZW
Roeselare, Belgium
Actively Recruiting
15
CHU UCL Namur asbl Site Godinne
Yvoir, Belgium
Actively Recruiting
16
IRCCS "Saverio de Bellis", National Institute of Gastroenterology
Castellana Grotte, Italy
Not Yet Recruiting
17
Azienda Ospedaliero Universitaria Careggi Padiglione San Luca Nuovo
Florence, Italy
Actively Recruiting
18
IRCCS Ospedale San Raffaele
Milan, Italy
Actively Recruiting
19
Agostino Gemelli University Policlinic
Roma, Italy
Not Yet Recruiting
20
San Camillo-Forlanini Hospital
Rome, Italy
Not Yet Recruiting
21
UOC di Gastroenterologia ed Endoscopia Digestiva
San Giovanni Rotondo, Italy
Not Yet Recruiting
22
Flevoziekenhuis Hospitaalweg 1
Almere Stad, Netherlands
Not Yet Recruiting
23
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
24
OLVG Oost
Amsterdam, Netherlands
Actively Recruiting
25
Maastricht UMC
Maastricht, Netherlands
Actively Recruiting
26
Radboudumc
Nijmegen, Netherlands
Actively Recruiting
27
Elisabeth-TweeSteden Ziekenhuis (ETZ)
Tilburg, Netherlands
Actively Recruiting
28
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Actively Recruiting
29
UKC Ljubljana
Ljubljana, Slovenia
Not Yet Recruiting
30
Northern Care Alliance - Fairfield General Hospital
Bury, United Kingdom
Actively Recruiting
31
Cambridge University Hospitals NHS Trust
Cambridge, United Kingdom
Actively Recruiting
32
Hull University Teaching Hospital NHS Trust
Cottingham, United Kingdom
Actively Recruiting
33
The Dudley Group NHS Foundation Trust
Dudley, United Kingdom
Actively Recruiting
34
Cardiff & Vale UHB
Llandough, United Kingdom
Actively Recruiting
35
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom
Actively Recruiting
36
King's College Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
37
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Actively Recruiting
38
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Actively Recruiting
39
Hampshire Hospital NHS Foundation Trust
Winchester, United Kingdom
Actively Recruiting
Research Team
S
Susan Archer
L
Lauren Schleicher
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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