NCT06788340Not yet recruitingPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - An Independent Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to investigate if dosage of Ustekinumab (UST) and Vedolizumab (VDZ) based on Model-Informed Precision Dosing (MIPD) is equally as efficient in keeping adults with Inflammatory Bowel Disease (IBD) in remission as management based on what the treating physician deems best. The main question is: Is using pharmacokinetic-pharmacodynamic (PK-PD) models to predict the appropriate dose and dosing interval for VDZ and UST at least as effective as current practices in maintaining IBD remission. As above mentioned the comparison-group is adults with IBD, treated with UST or VDZ, managed as the physician deems best. Participants will: Have blood and stool tests done, as well as answer a questionnaire 4th weekly Have their dosage frequency decided on either by the PK-model or as the physician deems best visit the clinic once every 24 weeks for checkups. Have an endoscopy done at completion of the study (if the disease is primarily located in the small intestine, MRI or capsule endoscopy will be used instead)
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 166 (estimated)
- First submitted
- 7 Jan 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Odense University Hospital
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06788340
- EU CT number
- 2024-517123-39-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 166
- From 1 Sept 2025 to the primary completion date, 30 Aug 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Fistulizing disease being the primary reason for treatment with VDZ or UST
- Expected eminent change of therapy
- Expected need for surgical intervention within the coming 3 months
- Contraindication against continuing treatment with VDZ or UST, including prior acute or delayed infusion reaction to VDZ or UST
Other illness
- Any active infection requiring parenteral treatment, known infection with tuberculosis, human immunodeficiency virus (HIV) or hepatitis virus.
- Any condition which the responsible physician finds incompatible with participation in the study
Other
- Having a diagnose of indeterminate colitis
- Having a stoma or pouch
- Patients unable to participate in the collection of symptoms scores
- Patients who are pregnant or nursing at time of inclusion
Who the study is looking for
- Ulcerative colitis or Crohn's disease. Diagnosed, according to universally acknowledged criteria, a minimum of 3 months prior to inclusion
- Age ≥ 18
- Stable treatment with VDZ or UST for at least 3 months prior to inclusion
- Stable disease activity, mild activity is accepted, defined by fecal calprotectin ≤ 200, and a weighted PRO2 \< 14 for CD or a PRO2 ≤3 for UC
- No change in medical therapy within 3 months prior to inclusion, as concomitant therapy with other immune suppressants is allowed (Azathioprine, 6-mercaptopurine, Methotrexate, 5-aminosalicylic acid)
- The patient must be able to understand patient information material
- The patient must be able to give informed written consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Esbjerg Og Grindsted Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Recruiting |
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Nyborg | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Sygehus Lillebaelt - Vejle Sygehus Coordinator of this site? Confirm its status | Vejle | Denmark | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.