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

NCT ID: NCT06788340

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-11-01

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)

Detailed Description

Patients will 4th weekly have their drug-concentration in blood measured (and if low, also antidrug antibodies). Hemoglobin, Albumin, CRP and white blood cell count will also be done, as well as a stool-sample for calprotectin measurement.

For the control group however, the clinicians and patients will be blinded for the results of the blood- and stool samples, and the samples for drug concentration will not get analyzed before end of study.

4th weekly they will also answer PRO2 questionnaire, as well as the VAS-F. 8th weekly they will in addition to above mentioned also answer the EQ-5D-5L questionnaire.

At inclusion, after 24 weeks, and at 48 weeks the patients will in addition to the above mentioned also answer the short IBDQ and WPAI questionnaires, as well as be seen in the outpatient clinic to obtain HBI or SCCAI score as applicable, as well as to document any changes in concomitant medication or diseases, and to register if any serious adverse events have presented.

At completion of the trial, patients will have a endoscopy done.

In one subprotocol, the investigators will include 20 patients from Odense to have an endoscopy at both inclusion and completion. Here they will also have biopsies taken from all segments of the colon, which will be stores in a biobank for future research.

In another subprotocol 20 patients will be included to have a intestinal ultrasound done at inclusion and completion.

In a biobank for future research the investigators will also store serum-samples, buffy coat, and stool samples collected at inclusion, after 24 and 48 weeks from all included patients.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PK-model to decide when to dose Vedolizumab and Ustekinumab

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark A Ainsworth, professor, DMSc

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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

Countries

Denmark

Central Contacts

Camilla Frimor, MD

Role: CONTACT

camilla.frimor@rsyd.dk

+45 22 56 72 57

Mark A Ainsworth

Role: CONTACT

mark.ainsworth@rsyd.dk

Facility Contacts

Lone Larsen, MD, PhD

Role: primary

lone.larsen@rn.dk

97663572

Morten L Halling, MD, PhD

Role: primary

morten.halling@rsyd.dk

79184527

Johan Burisch, MD, PhD

Role: primary

johan.burisch@regionh.dk

26450363

Camilla Frimor, MD

Role: primary

camilla.frimor@rsyd.dk

22567257

Camilla Frimor, MD

Role: primary

camilla.frimor@rsyd.dk

4522567257

Maiken T Jørgensen, MD, PhD

Role: primary

maiken.t.joergensen@rsyd.dk

22905500

Other Identifiers

2024-517123-39-00

Identifier Type: CTIS

Identifier Source: secondary_id

32844

Identifier Type: -

Identifier Source: org_study_id