NCT06788340: MOVE-IT

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

Not yet recruiting Phase 4 Last updated 31 July 2025

What this trial tests

Phase 4 trial testing PK-model to decide when to dose Vedolizumab and Ustekinumab in Inflammatory Bowel Diseases in 166 participants. Not yet recruiting.

Timeline

1 September 2025

Primary endpoint
30 August 2027

1 November 2027

Quick facts

Lead sponsor	Odense University Hospital
Phase	Phase 4
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	166
Start date	1 September 2025
Primary completion	30 August 2027
Estimated completion	1 November 2027
Sites	6 locations across Denmark

Drugs / interventions tested

• PK-model to decide when to dose Vedolizumab and Ustekinumab — full drug profile →

Conditions studied

• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
• Crohn Disease — all drugs for Crohn Disease →
• Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Odense University Hospital

Who can join

18 and older, any sex, with Inflammatory Bowel Diseases or Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. MOdel-informed precision dosing (MIPD) of ustekinumab and VEdolizumab in inflammatory bowel disease: protocol for an Independent randomised, controlled, multicentre Trial (MOVE-IT).
   Frimor C, Frimor C, Steenholdt C, Widigson ESK, et al · · 2025 · PMID 41453773 · DOI 10.1136/bmjgast-2025-001985