RecruitingNAINTERVENTIONAL

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

This research is testing a new approach to help doctors choose the best medicine for adults with Crohn's disease. Currently, doctors pick treatments based on standard guidelines. This study compares that usual method with a new one that uses a special blood test. This blood test looks at tiny changes in your genes, called epigenetics, which might help predict how well certain medicines will work for you. The study aims to see if using this new blood test to guide treatment choices leads to better results for patients, is safe, and is good value for money. Participants will either have their treatment chosen by this new test or by their doctor in the usual way, and their progress will be carefully followed.

At a glance

Status

Recruiting

Phase

Sponsor

Alimentiv Inc.

Enrolment target

378

Start

01 Feb 2025

Estimated completion

01 Jan 2029

Crohn Disease (CD)

What is this study about?

This research study is about finding better ways to choose medicines for people with Crohn's disease. When you have Crohn's, your doctor currently decides on the best 'biologic' medication using what's known as 'standard of care' – that's the usual way doctors treat the condition based on guidelines and experience. This study is exploring a new idea. It involves a special blood test that looks at something called 'epigenetic markers'. Think of these markers as tiny switches on your genes that can turn them on or off, and these switches might give clues as to which medicine will work best for you.

Researchers want to see if using the information from this special blood test helps doctors pick a better biologic medicine for you compared to the standard way. The study aims to answer three key questions: Does this new method work better? Is it safe for patients? And is it a good use of healthcare money?

About 378 adults with active Crohn's disease will take part. Half of them will have their treatment chosen based on the results of the special blood test, and the other half will have their treatment chosen in the usual way by their doctor. The study will then compare how well both groups respond to their treatment over time.

Key takeaways

Tests a new blood test to help choose Crohn's disease treatment.
Compares this new method to your doctor's usual treatment choice.
Aims for safer, more effective, and good-value care.
Involves regular check-ups over about two years.
You might be considered if you have active Crohn's and are an adult.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and have a confirmed diagnosis of active Crohn's disease. Your doctor will need to confirm that your Crohn's is currently active based on specific medical scores and an examination.

You must also be eligible to receive certain biologic medications (Vedolizumab or Ustekinumab) based on standard UK guidelines. This includes making sure you don't have certain ongoing infections like HIV or Hepatitis, and that you're not pregnant or breastfeeding. If you could become pregnant, you'll need to agree to use effective contraception during the study.

If you're already taking other Crohn's medications or steroids, there are rules about how long you've been on them and whether your dose is stable. Your doctor will make sure you understand the study and can follow its instructions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a confirmed diagnosis of active Crohn's disease?
Are you able to take either Vedolizumab or Ustekinumab?
Are you able to use contraception if you could become pregnant?
Are you willing to let your doctor monitor your health closely during the study?

Answer every question to see your result.

What does participation involve?

If you join the study, you will have a blood sample taken at the start. Based on a special test or your doctor's usual judgment, you'll be given one of two biologic medicines for your Crohn's disease. You'll take this medicine according to the standard instructions, and your doctor can adjust the dose if needed.

During the first 26 weeks, you'll have several study visits for assessments to check how you're doing. These visits will usually happen around weeks 6, 8, 14, 16, and 26, depending on the medicine you receive. After this, you'll have check-ups every six months for a further 18 months (at months 12, 18, and 24). The total study duration, including long-term follow-up, will be about two years.

Potential risks and benefits

Participating in this study might offer you the benefit of potentially receiving a treatment that is better matched to your body through a new personalized approach, which could lead to better control of your Crohn's disease. However, there's also a chance the new method might not be more effective than standard care. All treatments carry potential side effects, and you will be closely monitored for these, just as you would with any new medication. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (39)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GZA Antwerpen
Verified postcode
Antwerp, Belgium· Not yet recruiting
Imeldahospital
Verified postcode
Bonheiden, Belgium· Recruiting
AZ Klina
Verified postcode
Brasschaat, Belgium· Recruiting
H.U.B. - Hôpital Erasme
Verified postcode
Brussels, Belgium· Recruiting
Universitair Ziekenhuis Antwerpen (UZA)
Verified postcode
Edegem, Belgium· Recruiting
AZ Maria Middelares
Verified postcode
Ghent, Belgium· Recruiting
AZ Sint Lucas
Verified postcode
Ghent, Belgium· Recruiting
UZ Ghent
Verified postcode
Ghent, Belgium· Recruiting
UZ Leuven Gasthuisberg
Verified postcode
Leuven, Belgium· Recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Recruiting
Centre Hospitalier Universitaire (CHU) de Liege
Verified postcode
Liège, Belgium· Recruiting
Groupe sante CHC/Clique du MontLegia
Verified postcode
Liège, Belgium· Recruiting

Common questions

What is 'epigenetic-guided treatment'?

It's a new way to pick medicines for Crohn's using a special blood test that looks at tiny switches on your genes, hoping to find a treatment that works best for you.

What are 'biologic therapies'?

These are special, often injected, medicines used for conditions like Crohn's disease that target specific parts of your immune system to reduce inflammation.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning both you and your doctor will know which biologic medicine you are taking.

What if I'm already taking other Crohn's medicines?

You might still be eligible, but any existing non-biologic treatments need to have been started at least 3 months before and be at a stable dose for at least 2 weeks.

How long will the study last for me?

Your active treatment period will be 26 weeks, followed by long-term check-ups every six months for about two years in total.

How to find out more

Susan Archer

susan.archer@alimentiv.com Official trial record

Always speak to your GP or specialist before deciding to take part in a study.