MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Phase 4 · Testing PK-model to decide when to dose Vedolizumab and Ustekinumab · 6 sites · Odense University Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing PK-model to decide when to dose Vedolizumab and Ustekinumab (a drug) as a possible treatment. Condition(s) listed: Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 4 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 166 participants are expected to take part.
- Start date: 2025-09-01 (planned).
- Main results expected around 2027-08-30 (estimate from the record).
- 6 study sites listed in Denmark.
Main thing being measured
- The fraction of patients in steroid-free remission (at the end of the observation period (48 weeks))
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis |
| Lead sponsor | Odense University Hospital |
| Enrollment | 166 (estimated) |
| Start date | 2025-09-01 |
| Primary completion (est.) | 2027-08-30 |
| First posted | 2025-01-23 |
| Last updated | 2025-07-31 |
| Official title | MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - An Independent Randomized Controlled Trial |
| ClinicalTrials.gov ID | NCT06788340 |
Interventions
- PK-model to decide when to dose Vedolizumab and Ustekinumab (Drug)
the pharmacokinetic model will include information about inflammatory parameters both in blood- and fecal samples, as well as weight, sex, previous treatments and drug concentration.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Exclusion Criteria: * Having a diagnose of indeterminate colitis * Having a stoma or pouch * 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 * 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 * Patients unable to participate in the collection of symptoms scores * Patients who are pregnant or nursing at time of inclusion
Locations (6)
| Site | City | Country | Site status |
|---|---|---|---|
| Dept. of Gastrointestinal Diseases | Aalborg | Denmark | |
| Dept. of Internal Medicin | Esbjerg | Denmark | |
| Dept. of Gastrointestinal Diseases | Hvidovre | Denmark | |
| Dept. of medicine | Nyborg | Denmark | |
| Dept. of Gastrointestinal Diseases | Odense | Denmark | |
| Dept. of Medicine | Vejle | Denmark |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.