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 2026-01-23
378
Participants Needed
30
Research Sites
204 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
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).
CONDITIONS
Official 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).
- Eligible to receive Vedolizumab and/or Ustekinumab therapy for Crohn's Disease as per approved label and physician opinion.
- Meet all local standard-of-care criteria for biologic therapy initiation, including absence of chronic or opportunistic infections.
- Nonpregnant and nonlactating; participants of childbearing potential must agree to contraception and avoid pregnancy until Week 26.
- Stable dose of nonbiologic inflammatory bowel disease therapies started at least 3 months before screening.
- If on oral corticosteroids, dose must be stable and within specified limits, with willingness to taper after biologic initiation.
- Ability to understand and comply with study protocol and treatment requirements.
- Able to fully participate in all aspects of the clinical study and provide informed consent.
You will not qualify if you...
- Prior treatment with Vedolizumab or Ustekinumab.
- Prior treatment with more than one advanced therapy (biologic or small molecule) for Crohn's Disease.
- Crohn's Disease complications interfering with participation, such as ileorectal anastomosis, proctocolectomy, short bowel syndrome, ostomies, symptomatic strictures, or untreated abscesses.
- History or current diagnosis of ulcerative colitis, indeterminate colitis, idiopathic colitis, microscopic colitis, or colonic mucosal dysplasia (except in resected adenomas).
- Increased risk of infections, including recent pyogenic infection, immunodeficiency, or past organ/bone marrow/stem cell 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).
- Fecal microbiota transplant within 4 weeks prior to randomisation.
- Major surgery within 8 weeks prior to randomisation or planned during the study.
- History of excessive alcohol or drug abuse that may interfere with study participation.
- Serious underlying diseases that may interfere with 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
Trial Site Locations
Total: 30 locations
1
Imeldahospital
Bonheiden, Belgium
Actively Recruiting
2
AZ Klina
Brasschaat, Belgium
Actively Recruiting
3
H.U.B. - Hôpital Erasme
Brussels, Belgium
Actively Recruiting
4
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Belgium
Actively Recruiting
5
AZ Maria Middelares
Ghent, Belgium
Actively Recruiting
6
AZ Sint Lucas
Ghent, Belgium
Actively Recruiting
7
UZ Gent
Ghent, Belgium
Actively Recruiting
8
UZ Leuven
Leuven, Belgium
Actively Recruiting
9
Centre Hospitalier Universitaire (CHU) de Liege
Liège, Belgium
Actively Recruiting
10
Groupe sante CHC/Clique du MontLegia
Liège, Belgium
Actively Recruiting
11
AZ Oostende
Ostend, Belgium
Actively Recruiting
12
AZ Delta VZW
Roeselare, Belgium
Actively Recruiting
13
CHU UCL Namur asbl Site Godinne
Yvoir, Belgium
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14
IRCCS Ospedale San Raffaele
Milan, Italy
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15
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
16
OLVG Oost
Amsterdam, Netherlands
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17
Maastricht UMC
Maastricht, Netherlands
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18
Radboudumc
Nijmegen, Netherlands
Actively Recruiting
19
Elisabeth-TweeSteden Ziekenhuis (ETZ)
Tilburg, Netherlands
Actively Recruiting
20
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
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21
Northern Care Alliance - Fairfield General Hospital
Bury, United Kingdom
Actively Recruiting
22
Cambridge University Hospitals NHS Trust
Cambridge, United Kingdom
Actively Recruiting
23
Hull University Teaching Hospital NHS Trust
Cottingham, United Kingdom
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24
The Dudley Group NHS Foundation Trust
Dudley, United Kingdom
Actively Recruiting
25
Cardiff & Vale UHB
Llandough, United Kingdom
Actively Recruiting
26
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom
Actively Recruiting
27
King's College Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
28
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Actively Recruiting
29
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Actively Recruiting
30
Hampshire Hospital NHS Foundation Trust
Winchester, United Kingdom
Actively Recruiting
Research Team
S
Susan Archer
CONTACT
L
Lauren Schleicher
CONTACT
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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