At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Epigenome-Guided Treatment Arm (device), Investigator-Guided Treatment Arm (other)
- How long the study runs
- Study runs about 47 months (dates as stated)
- About the drug or intervention
- Epigenome-Guided Treatment Arm — device: Participants will receive UST or VDZ biologic therapy as indicated by an epigenome read-out of peripheral blood using a hybrid capture-based methylation assay. · Investigator-Guided Treatment Arm — other: Assigned to UST or VDZ per conventional SOC and without the use or knowledge of epigenome results.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at adults with active Crohn's disease. It compares choosing treatment based on epigenetic markers (signals in the body) with the usual way doctors choose standard treatment. The treatments involved are vedolizumab (VDZ) and/or ustekinumab (UST).
Who can take part
- Aged 18 or over
- Diagnosed Crohn's disease of the ileum, colon, or both, with active disease confirmed by symptom scores and a camera test
- Able to receive vedolizumab and/or ustekinumab according to the drug labels and their doctor's opinion
- Free from long-term or active infections such as HIV, tuberculosis, cytomegalovirus, hepatitis B and C, and C. difficile, following local checks
- Not pregnant or breastfeeding, and agreeing to avoid pregnancy until Week 26 if applicable
- If on non-biologic Crohn's medicines (like thiopurines or methotrexate), started at least 3 months ago and on a stable dose for at least 2 weeks
- If on steroid tablets, on a stable dose within set limits for at least 2 weeks and willing to start reducing within 2 weeks of starting biologic treatment
- Able to understand and follow the study requirements and give informed consent
Who may not be able to
- Previous treatment with vedolizumab or ustekinumab
- Previous treatment with more than one advanced therapy (biologic or advanced oral small molecule) for Crohn's disease
- Crohn's complications that could interfere with the study, such as certain bowel surgeries, short bowel syndrome, ostomies, or problem strictures
- Untreated abscesses in the abdomen or around the anus
- Current or past ulcerative colitis, indeterminate colitis, microscopic colitis, or certain pre-cancerous cell changes in the colon
- Higher risk of infection, such as recent serious infection or a weakened immune system, or past organ, bone marrow, or stem cell transplant
- Rectal treatments for Crohn's within 2 weeks before the screening camera test
- Regular use of NSAID painkillers (except celecoxib)
- Faecal microbiota transplant within 4 weeks before randomisation
- Major surgery within 8 weeks before randomisation or planned during the study
- History of alcohol or drug misuse that could affect taking part
- Other serious health problems that could affect safety or participation, such as cancer history or a reason not to receive the study biologics
What taking part involves
- • Being assigned (by chance) to either treatment chosen using epigenetic markers or standard treatment selection
- • Receiving biologic treatment with vedolizumab and/or ustekinumab
- • Follow-up in the study at least up to Week 26
Time commitment: Not stated in full — the data mentions follow-up to Week 26, a baseline camera test, and pregnancy avoidance up to Week 26; ask the trial team about number of visits and total study duration.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 378
- Started
- 2025-02-01
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for crohn disease (cd)
- • NA - 378 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with crohn disease (cd)
Where?
- • Bury - Northern Care Alliance - Fairfield General Hospital
- • Cambridge - Cambridge University Hospitals NHS Trust
- • Cottingham - Hull University Teaching Hospital NHS Trust
- • Dudley - The Dudley Group NHS Foundation Trust
- • +6 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
This trial will include 378 participants with active CD, defined as an HBI \> 6 and the presence of endoscopic ulceration. Approximately 50% of the enrolled population will be bio-naïve and 50% exposed to no more than 1 prior biologic. Eligible participants will be randomised 1:1 to either epigenome-guided treatment selection or usual SOC treatment selection. Randomization will be stratified by prior biologic use (yes/no) and corticosteroid use (yes/no) at baseline. Blood samples for the assessment will be collected for all participants during screening. Peripheral blood will be tested via a machine-learning-powered epigenetic biomarker assay. EpiPredict is a software designed for CSV file input, data transfer, storage, and display, and will be serving as a EpiPredict clinical decision support system. It recommends treatment selections for 2 biologics (Vedolizumab (VDZ) and Vedolizumab (UST)) for CD utilizing genetic data. The intervention (EpiPredict software) will indicate the probability of response to both VDZ and UST (though sites will only be provided with the treatment with the highest outcome) for the treatment of CD using a hybrid capture-based methylation assay (approved for research use only) and the EpiPredict software. All participants in the study will be administered their biologic therapy in accordance with the product label and local SOC recommendations. Dose adjustments will be allowed in both groups at the treating investigator's discretion. During the 26-week treatment period, the study assessments will follow the SOC regimen of the assigned biologic treatment. For participants receiving VDZ, study assessments are to occur at Weeks 6, 14, and 26; for participants receiving UST, study assessments are to occur at Weeks 8, 16, and 26. Long-term follow up assessments are to occur every 6 months (Months 12, 18, and 24) after Week 26. Data for long-term follow up assessments will be collected from the participant's medical records captured at routine SOC visits and online questionnaires.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ initiated at least 3 months
What the study is looking for
- ✓Participants must meet all of the following criteria for enrolment into the study:
- ✓Aged 18 years or older at the time of agreement to take part.
- ✓Documented diagnosis of ileal, ileocolonic, or colonic CD (may be confirmed at baseline study endoscopy).
- ✓Active CD, as defined by HBI \> 6 and SES-CD ≥ 6 for colitis/ileocolitis and ≥ 4 for ileitis only.
- ✓Eligible to receive either VDZ and/or UST therapy for the treatment of CD per the approved drug label requirements...
Who cannot take part
- ✗Participants who meet any of the following criteria are to be excluded from the study:
- ✗Prior treatment with VDZ or UST.
- ✗CD-related complications that in the opinion of the investigator would interfere with participation in the study,...
- ✗Ileorectal anastomosis (rectum \< 15 cm), or a proctocolectomy.
- ✗Short bowel syndrome.
See the full criteria
Where Is This Study? (10 UK sites)
Northern Care Alliance - Fairfield General Hospital
Bury, United Kingdom
Cambridge University Hospitals NHS Trust
Cambridge, United Kingdom
Hull University Teaching Hospital NHS Trust
Cottingham, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, United Kingdom
Cardiff & Vale UHB
Llandough, United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Hampshire Hospital NHS Foundation Trust
Winchester, United Kingdom
How to Get in Touch
Susan Archer
Sponsor contactCONTACT
Lauren Schleicher
Sponsor contactCONTACT
