Inflammatory Bowel DiseasesPhase 4MOVE-ITNCT06788340
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
A Phase 4 study testing PK-model to decide when to dose Vedolizumab and Ustekinumab in people with Inflammatory Bowel Diseases and Crohn Disease, run by Odense University Hospital at 6 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- PK-model to decide when to dose Vedolizumab and Ustekinumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 6 sitesDenmark
- Study dates
- 23 Jan 2026to 30 Nov 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Denmark6 sites
Dept. of Gastrointestinal Diseases
Aalborg, 9000
Dept. of Internal Medicin
Esbjerg, 6700
Dept. of Gastrointestinal Diseases
Hvidovre, 2650
Dept. of medicine
Nyborg, 5800
Dept. of Gastrointestinal Diseases
Odense, 5000
Dept. of Medicine
Vejle, 7100
About this study
Official title: MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - An Independent Randomized Controlled Trial
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.
Read more
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)
Read the 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.
- Being tested
- PK-model to decide when to dose Vedolizumab and Ustekinumab
- Keywords
- MIPD, Model-Informed Precision Dosing, Therapeutic Drug Monitoring, TDM, Inflammatory Bowel Disease, Crohn's disease, Ulcerative colitis, Biologic therapy, Ustekinumab, Vedolizumab
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PK-model to decide when to dose Vedolizumab and UstekinumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
for CD defined by patient reported outcome 2 (PRO2) stool frequency <= 3 and abdominal pain < = 1, for UC defined by PRO2, number of abnormal stools for the patient, bleeding from the rectum = 0) AND a fecal calprotectin ≤ 200.
Measured: 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)
expenditure on medicines (both expenditure on the purchase of medicines and expenditure on the administration of medicines), expenses for doctor visits / visits to a nurse, possibly expenses for hospitalization, possibly expenses for surgery, possibly expenses for sick leave and possibly expenses for early retirement.
After end of study, the investigators will collect data on sick leave etc. from the national patient registry.
Measured: through study completion, an average of 48 weeks
Endoscopic healing of the mucosa
for CD assessed by Simple Endoscopic Score for Crohn's Disease (SES-CD) <3; and for UC assessed on the basis of the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)≤1. If disease is primarily located in the small intestine, MRI or capsule endoscopy will be used instead, and assessed by the simplified MaRIA score <1 or Lewis score ≤135, respectively
Measured: at completion of study, approximately 48 weeks
Changes in quality of life during the study period
assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) difference between baseline and end of study. Improvement of quality of life indicated by a positive change of the SIBDQ. SIBDQ is collected at inclusion, week 24 and week 48. A higher the score, indicates a better outcome, Maksimum score of 70 points.
Measured: 48 weeks
Quality of life as QALYs
assessed by the EuroQol-5 dimensions-5 levels questionnaire (EQ-5D-5L) and converted to QALYs. The cost per QALY will also be calculated. EQ-5D-5L is collected every 8th week throughout the study. Score ranges from 5-25, a higher score indicating poorer quality of life.
Measured: 48 weeks
Clinical Disease Activity
assessed by Simplified Clinical Colitis Activity Index (SCCAI) for UC and Harvey-Bradshaw Index (HBI) for CD. These are collected at inclusion and every 24th week thereafter. SCCAI score ranges from 0-19, a higher score indicating a more severe disease activity. HBI score ranges from 0-20, a higher score indicating more severe disease activity.
Measured: 48 weeks
Inflammatory burden over the observational period
CRP, albumin, hemoglobin, leukocyte counts and fecal calprotectin. These will be collected every 4th week
Measured: 48 weeks
Expenses for analysis of drug concentration
patients will have drug concentrations analyzed every 4th week, the price of this will be collected
Measured: 48 weeks
Expenses for drugs
patients will typically administer sc VDZ every 4th to 2nd week, iv VDZ every 12th to 4th week and UST every 12th to 4th week
Measured: 48 weeks
Drug persistency
number of patients switching to another treatment during the study
Measured: 48 weeks
Disease flares
assessed by consumption of glucocorticoids or IBD-related surgery
Measured: 48 weeks
Fatigue
to assess if treating according to a PK-model results in less fatigue measured by Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F). Patients are asked to register how fatigued they feel every 4th week throughout the study. The VAS-F is a visual analogue scale that goes from 0-10, 10 indicating severe fatigue.
Measured: 48 weeks.
Disease impact on work productivity and performance of daily activities
Assessed by difference in Work Productivity and Activity Impairment questionnaire (WPAI) scores and changes in scores between patients in the intervention- and control group. WPAI is collected at inclusion and every 24th week throughout the study.
WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start23 Jan 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A Ainsworth, professor, DMSc, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788340
- Sponsor's protocol ID
- 32844
- Other IDs
- 2024-517123-39-00
- Acronym
- MOVE-IT
- Status last verified
- Sep 2026
- First submitted
- 7 Jan 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will possibly be shared, including clinical characteristics, laboratory test results, and patient-reported outcomes relevant to the study endpoints. Data will be available after publication of the main trial results and completion of any relevant follow-up studies. This is expected to occur approximately one year after the study's primary completion date. Data will be available for a minimum of 5 years following the publication of the trial results.
Publications
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.
PubMed 41453773
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - An Independent Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06788340
- Acronym / sponsor ID
- MOVE-IT / 32844
- Keywords
- MIPD, Model-Informed Precision Dosing, Therapeutic Drug Monitoring, TDM, Inflammatory Bowel Disease, Crohn's disease, Ulcerative colitis, Biologic therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model-informed precision dosing of Vedolizumab/Ustekinumab | Experimental | Drug: PK-model to decide when to dose Vedolizumab and UstekinumabPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PK-model to decide when to dose Vedolizumab and Ustekinumabthe pharmacokinetic model will include information about inflammatory parameters both in blood- and fecal samples, as well as weight, sex, previous treatments and drug concentration. | Drug | Model-informed precision dosing of Vedolizumab/Ustekinumab |
Primary outcome
The fraction of patients in steroid-free remission
Time frame: at the end of the observation period (48 weeks)
((for CD defined by PRO2 ≤ 4, for UC defined by PRO2 = 0) AND a fecal calprotectin ≤200)
13 secondary outcomes
The fraction of the observation period (48 weeks) where the disease is in steroid-free remission
Time frame: 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)
Time frame: through study completion, an average of 48 weeks
Endoscopic healing of the mucosa
Time frame: at completion of study, approximately 48 weeks
Changes in quality of life during the study period
Time frame: 48 weeks
Quality of life as QALYs
Time frame: 48 weeks
Clinical Disease Activity
Time frame: 48 weeks
Inflammatory burden over the observational period
Time frame: 48 weeks
Expenses for analysis of drug concentration
Time frame: 48 weeks
Expenses for drugs
Time frame: 48 weeks
Drug persistency
Time frame: 48 weeks
Disease flares
Time frame: 48 weeks
Fatigue
Time frame: 48 weeks.
Disease impact on work productivity and performance of daily activities
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 41453773Frimor 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will possibly be shared, including clinical characteristics, laboratory test results, and patient-reported outcomes relevant to the study endpoints. Data will be available after publication of the main trial results and completion of any relevant follow-up studies. This is expected to occur approximately one year after the study's primary completion date. Data will be available for a minimum of 5 years following the publication of the trial results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark A Ainsworth, professor, DMSc principal investigator
Odense University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PK-model to decide when to dose Vedolizumab and Ustekinumab in people with Inflammatory Bowel Diseases and Crohn Disease, run by Odense University Hospital at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The fraction of patients in steroid-free remission (time frame: at the end of the observation period (48 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06788340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.