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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Prevention of Postoperative Endoscopic Recurrence with Endoscopy-driven Versus Systematic Biological Therapy

Prevention of Postoperative Endoscopic Recurrence with Endoscopy-driven Versus Systematic Biological Therapy: a Randomized, Multicentre, Parallel Group Pragmatic Non-inferiority Trial in Crohn Disease

Prevention of Postoperative Endoscopic Recurrence with Endoscopy-driven Versus Systematic Biological Therapy (NCT05169593) is a Phase 4 interventional studying Crohn Disease, sponsored by Universitaire Ziekenhuizen Ku Leuven. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

With this prospective, randomized, multicentre, parallel group pragmatic non-inferiority trial, the investigators will evaluate if endoscopy-driven introduction of biological therapy is not leading to more postoperative endoscopic recurrence at week 86 compared to systematic prophylactic biological therapy in patients with CD undergoing an ileocolonic resection with ileocolonic anastomosis. Secondary analyses will include influence on clinical, biological and surgical CD recurrence, serious adverse events, direct costs, work productivity, and quality of life. If the investigators can demonstrate the non-inferiority of an endoscopy-driven approach, this patient-tailored management could be advocated, while a more expensive systematic introduction of biological therapies could be limited. Finally, endoscopic images provided through the SOPRANO CD study, will be used to develop a new scoring system evaluating postoperative endoscopic recurrence.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 292 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Crohn Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntary written willing to sign a consent form 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 Who Should NOT Join This Trial: 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.. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Biological Drug

Biological therapy used in daily clinical practice in patients with Crohn's disease to prevent disease recurrence

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

GZA
Antwerp, Antwerpen, Belgium
UZA
Edegem, Antwerpen, Belgium
Erasmus ziekenhuis
Brussels, Brussels Capital, Belgium
Cliniques Universitaires Saint Luc
Brussels, Brussels Capital, Belgium
UZ Brussel
Jette, Brussels Capital, Belgium
CHwapi
Tournai, Henegouwen, Belgium
ZOL Genk
Genk, Limburg, Belgium
CHC Montlégia
Liège, Liège, Belgium
CHU de Liège
Liège, Liège, Belgium
CHU UCL Namur site Godinne
Yvoir, Namur, Belgium
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Sint lucas Brugge
Bruges, West-Vlaanderen, Belgium
AZ Damiaan
Ostend, West-Vlaanderen, Belgium
OLV Aalst
Aalst, Belgium
Imeldaziekenhuis
Bonheiden, Belgium
AZ Klina
Brasschaat, Belgium
AZ Sint-Jan
Bruges, Belgium
AZ Sint Lucas
Ghent, Belgium

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05169593), the sponsor (Universitaire Ziekenhuizen Ku Leuven), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05169593 clinical trial studying?

With this prospective, randomized, multicentre, parallel group pragmatic non-inferiority trial, the investigators will evaluate if endoscopy-driven introduction of biological therapy is not leading to more postoperative endoscopic recurrence at week 86 compared to systematic prophylactic biological therapy in patients with CD undergoing an ileocolonic resection with ileocolonic anastomosis. Secondary analyses will include influence on clinical, biological and surgical CD recurrence, serious adverse events, direct costs, work productivity, and quality of life. If the investigators can demonstra… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05169593?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05169593?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05169593. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05169593. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.