Recruiting

Testing a blood test to guide inflammatory bowel disease treatment choice

Plain-English translation of NCT07363044 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing whether a personalized blood test called an epigenetic biomarker can help doctors choose between two biologic medications — Vedolizumab and Ustekinumab — for treating Crohn's disease. Half of the participants will be assigned their medication based on what this blood test recommends, while the other half will receive treatment chosen the usual way by their doctor. All participants will take their assigned biologic medication and be monitored for 26 weeks to see how well it works.

Many people with Crohn's disease don't respond well to their first biologic medication, which means trying different treatments and waiting weeks before switching. This trial is testing whether a blood test can predict which medication will work best for each person upfront, potentially helping patients find the right treatment faster and with fewer failed attempts.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with Crohn's disease affecting the small intestine, colon, or both
you have active Crohn's disease confirmed by your doctor (shown by symptoms and endoscopy findings)
you have not taken Vedolizumab or Ustekinumab before
you have taken no more than one prior biologic medication
you are willing to use contraception and avoid pregnancy during the 26-week treatment period if you could become pregnant

You likely don't qualify if…

you have already taken Vedolizumab or Ustekinumab
you have taken two or more different biologic medications in the past
you have a Crohn's disease complication that would interfere with the study, such as a surgical pouch, short bowel syndrome, or an ostomy
you have certain infections, including uncontrolled tuberculosis or hepatitis B or C
you have had significant bowel narrowing or blockage that causes symptoms

What participation looks like

If you join, you'll have a blood test taken at your first visit so your blood can be analyzed. Then you'll be randomly assigned to either receive medication chosen by the blood test results or medication chosen the traditional way by your doctor. You'll receive your biologic medication as an infusion or injection according to the medication's standard schedule. You'll have study visits at weeks 6, 8, 14, or 16 (depending on which medication you receive) and week 26, then follow-up visits every 6 months for up to 2 years. Each visit includes assessments to check how well your treatment is working.

AI-generated summary from trial data · Jun 2, 2026 · Not medical advice

Trial locations(39 sites)

Belgium

GZA Antwerpen, Antwerp

Imeldahospital, Bonheiden

AZ Klina, Brasschaat

H.U.B. - Hôpital Erasme, Brussels

Universitair Ziekenhuis Antwerpen (UZA), Edegem