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NOT YET RECRUITING
NCT06788340
PHASE4

MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease

Sponsor: Odense University Hospital

View on ClinicalTrials.gov

Summary

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)

Official title: MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - An Independent Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2025-09-01

Completion Date

2027-11-01

Last Updated

2025-07-31

Healthy Volunteers

No

Interventions

DRUG

PK-model to decide when to dose Vedolizumab and Ustekinumab

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.

Locations (6)

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