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

Sponsor
Odense University Hospital
Study ID
NCT06788340
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Sep 1, 2025
Status verified
Jul 2025
Primary completion
Aug 30, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
166 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Model-informed precision dosing of Vedolizumab/Ustekinumab
    Patients will have blood- and stool samples collected, as well as date and time of drug administration every 4th week. All of these informations, in addition to some informations collected at inclusion, will be used in a PK-model to prescribe when the next dosage of drug should be administered to keep the patient in the therapeutic window.
  • No Intervention: Dosing of Vedolizumab/Ustekinumab by physicians best clinical assessment
    Patients will have blood- and stool samples collected every 4 weeks, but these will be blinded for the physicians. They are to be treated as regular patients, but will be seen every 24 weeks to collect clinical activity scores, register alterations in concomitant medication and possible serious adverse events.

Primary Outcome Measure

The fraction of patients in steroid-free remission [ Time Frame: at the end of the observation period (48 weeks) ]

Central Contacts

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