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

NCT06788340 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: 328442024-517123-39-00
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 6

Brief 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)

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Keywords

MIPD; Model-Informed Precision Dosing; Therapeutic Drug Monitoring; TDM; Inflammatory Bowel Disease; Crohn's disease; Ulcerative colitis; Biologic therapy; Ustekinumab; Vedolizumab

Outcome Measures

Primary Outcomes (1)

• The fraction of patients in steroid-free remission

  ((for CD defined by PRO2 ≤ 4, for UC defined by PRO2 = 0) AND a fecal calprotectin ≤200)

  at the end of the observation period (48 weeks)

Secondary Outcomes (13)

• The fraction of the observation period (48 weeks) where the disease is in steroid-free remission

  this is registered every 4th week throughout the study duration of 48 weeks.

• The financial costs associated with the two treatment strategies over the observation period (12 months)

  through study completion, an average of 48 weeks

• Endoscopic healing of the mucosa

  at completion of study, approximately 48 weeks

• Changes in quality of life during the study period

  48 weeks

• Quality of life as QALYs

  48 weeks

Study Arms (2)

Model-informed precision dosing of Vedolizumab/Ustekinumab

EXPERIMENTAL

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.

Drug: PK-model to decide when to dose Vedolizumab and Ustekinumab

Dosing of Vedolizumab/Ustekinumab by physicians best clinical assessment

NO INTERVENTION

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.

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.

Model-informed precision dosing of Vedolizumab/Ustekinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• 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
• The patient must be able to understand patient information material
• The patient must be able to give informed written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (6)

Dept. of Gastrointestinal Diseases

Aalborg, 9000, Denmark

Location

Dept. of Internal Medicin

Esbjerg, 6700, Denmark

Location

Dept. of Gastrointestinal Diseases

Hvidovre, 2650, Denmark

Location

Dept. of medicine

Nyborg, 5800, Denmark

Location

Dept. of Gastrointestinal Diseases

Odense, 5000, Denmark

Location

Dept. of Medicine

Vejle, 7100, Denmark

Location

Related Publications (1)

• Frimor C, Steenholdt C, Widigson ESK, Kjeldsen J, Larsen L, Burisch J, Joergensen MT, Halling ML, Kloft C, Ainsworth MA. MOdel-informed precision dosing (MIPD) of ustekinumab and VEdolizumab in inflammatory bowel disease: protocol for an Independent randomised, controlled, multicentre Trial (MOVE-IT). BMJ Open Gastroenterol. 2025 Dec 25;12(1):e001985. doi: 10.1136/bmjgast-2025-001985.

  PMID: 41453773 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mark A Ainsworth, professor, DMSc

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Frimor, MD

CONTACT

+45 22 56 72 57; camilla.frimor@rsyd.dk

Mark A Ainsworth

CONTACT

mark.ainsworth@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 23, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: will become available approximately March 2028 and will be available for at least 5 years
• Access Criteria: Data will be shared with qualified researchers conducting legitimate scientific inquiries, particularly those working within the field of inflammatory bowel disease (IBD) and therapeutic drug monitoring (TDM)

Locations

DK (6)