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Crohn's patients may avoid unnecessary drugs after surgery, new study suggests

NCT ID NCT05169593

Prevention Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether starting biologic drugs only after seeing signs of Crohn's disease on a colonoscopy is as good as starting them right after surgery to prevent the disease from coming back. About 292 adults with Crohn's who had bowel surgery will be randomly assigned to one of two approaches. If the wait-and-see approach works, it could mean fewer people need strong medications right away.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 292 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. 2. Patients with a diagnosis of Crohn's disease based on radiology, endoscopy and/or histology 3. Males and females 18-80 years old. 4. Patients undergoing an ileocolonic resection with ileocolonic anastomosis (with or without temporary ileostomy) within 3 and 40 days prior to the Screening visit. Patients who underwent an ileocolonic resection with ileocolonic anastomosis with a temporary ileostomy are also eligible if the ileocolonic resection was performed within eight months prior to the Screening visit, and the restoration of the faecal stream was performed within 3 and 40 days prior to the Screening visit. 5. Patients having an increased risk for postoperative recurrence for any of the following reasons: 1. Penetrating disease as reason for ileocolonic resection 2. Previous ileocolonic resection within ten years of index surgery 3. Two or more previous ileocolonic resections 4. Active smoking 5. Biological therapy for Crohn's disease within 3 months of index ileocolonic resection 6. Curative ileocolonic resection. All inflamed colon segments should have been removed. Strictureplasties in the small bowel not involving the anastomotic region are allowed. 7. Patients previously failing at least three months of steroids and/or three months of immunosuppressive therapy, or showing intolerance or a real contraindication for any of these therapies. 8. Patients able and willing to start and continue biological therapy, and this at the timepoint indicated through study randomization Exclusion Criteria: 1. Participant has a history of primary non response or secondary loss of response to all five biological therapies of interest, namely adalimumab, infliximab, ustekinumab, vedolizumab and risankizumab.. 2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol. 3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial. 4. Participation in an interventional Trial with an Investigational Medicinal Product (IMP) or device. 5. Patients initiating biological therapy for CD as part of another clinical trial or a medical need program. 6. Patients not understanding Dutch, French, German or English. 7. Patients with ulcerative colitis or inflammatory bowel disease type unclassified. 8. Patients with an ileorectal anastomosis, or an ileal pouch-anal anastomosis. 9. Patients with active perianal disease. 10. Patients with a colorectal stenosis. 11. Patients with an ostomy. 12. Patients with sepsis or other postoperative complications necessitating the use of antibiotics for more than ten days after ileocolonic resection or restoration of the faecal stream. 13. Patients with (an imminent risk) of a short bowel syndrome. 14. Patients who had qualifying ileocolonic resection for dysplasia or cancer without ongoing inflammation. 15. Patients with liver test abnormalities (aspartate transaminase, alanine transaminase, alkaline phosphatases, or bilirubin \> 2 upper limit of normal), leukopenia (\<3000 white blood cells 109/L, \<1500 neutrophils 109/L ), thrombocytopenia (platelets \< 50.000/mm3). 16. Patients with severe renal, pulmonary or cardiac disease. 17. Ongoing alcohol or substance abuse.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Damiaan

    RECRUITING

    Ostend, West-Vlaanderen, 8400, Belgium

  • AZ Delta

    RECRUITING

    Roeselare, 8800, Belgium

  • AZ Klina

    RECRUITING

    Brasschaat, 2930, Belgium

  • AZ Maria Middelares

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • AZ Sint Lucas

    RECRUITING

    Ghent, 9000, Belgium

  • AZ Sint Maarten

    WITHDRAWN

    Mechelen, 2800, Belgium

  • AZ Sint-Jan

    RECRUITING

    Bruges, 8000, Belgium

  • CHC Montlégia

    RECRUITING

    Liège, Liège, 4000, Belgium

  • CHU UCL Namur site Godinne

    NOT_YET_RECRUITING

    Yvoir, Namur, 5530, Belgium

  • CHU de Liège

    RECRUITING

    Liège, Liège, 4000, Belgium

  • CHwapi

    RECRUITING

    Tournai, Henegouwen, 7500, Belgium

  • Careggi University Hospital

    RECRUITING

    Florence, 50134, Italy

  • Cliniques Universitaires Saint Luc

    RECRUITING

    Brussels, Brussels Capital, 1200, Belgium

  • Erasmus ziekenhuis

    RECRUITING

    Brussels, Brussels Capital, 1070, Belgium

  • Humanitas research hospital

    NOT_YET_RECRUITING

    Milan, Rozzano MI, 20089, Italy

  • IRCCS De Bellis Castellana Grotte

    RECRUITING

    Castellana Grotte, 70013, Italy

  • IRCCS San Raffael Hospital

    RECRUITING

    Milan, 20132, Italy

  • Imeldaziekenhuis

    RECRUITING

    Bonheiden, 2820, Belgium

  • Jessa ziekenhuis

    RECRUITING

    Hasselt, 3500, Belgium

  • OLV Aalst

    RECRUITING

    Aalst, 9300, Belgium

  • Sint lucas Brugge

    NOT_YET_RECRUITING

    Bruges, West-Vlaanderen, 8310, Belgium

  • UZ Brussel

    RECRUITING

    Jette, Brussels Capital, 1090, Belgium

  • UZ Gent

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • UZA

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

  • Vitaz

    RECRUITING

    Sint-Niklaas, 9100, Belgium

  • ZAS

    RECRUITING

    Antwerp, Antwerpen, 2018, Belgium

  • ZOL Genk

    RECRUITING

    Genk, Limburg, 3600, Belgium

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