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MODEL-informert presisjonsdosering av Ustekinumab og VEdolizumab ved inflammatorisk tarmsykdom (MOVE-IT)

3. november 2026 oppdatert av: Odense University Hospital

MODel-informert presisjonsdosering (MIPD) av Ustekinumab og VEdolizumab ved inflammatorisk tarmsykdom – en uavhengig randomisert kontrollert studie

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)

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

166

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Danmark
      • Aalborg, Danmark, 9000
        • Dept. of Gastrointestinal Diseases
      • Esbjerg, Danmark, 6700
        • Dept. of Internal Medicin
      • Hvidovre, Danmark, 2650
        • Dept. of Gastrointestinal Diseases
      • Nyborg, Danmark, 5800
        • Dept. of medicine
      • Odense, Danmark, 5000
        • Dept. of Gastrointestinal Diseases
      • Vejle, Danmark, 7100
        • Dept. of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The fraction of patients in steroid-free remission
Tidsramme: 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)
at the end of the observation period (48 weeks)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The fraction of the observation period (48 weeks) where the disease is in steroid-free remission
Tidsramme: this is registered every 4th week throughout the study duration of 48 weeks.

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.
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)
Tidsramme: through study completion, an average of 48 weeks

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.
through study completion, an average of 48 weeks
Endoscopic healing of the mucosa
Tidsramme: at completion of study, approximately 48 weeks

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
at completion of study, approximately 48 weeks
Changes in quality of life during the study period
Tidsramme: 48 weeks

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.
48 weeks
Quality of life as QALYs
Tidsramme: 48 weeks

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.
48 weeks
Clinical Disease Activity
Tidsramme: 48 weeks

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.
48 weeks
Inflammatory burden over the observational period
Tidsramme: 48 weeks

CRP, albumin, hemoglobin, leukocyte counts and fecal calprotectin. These will be collected every 4th week
48 weeks
Expenses for analysis of drug concentration
Tidsramme: 48 weeks

patients will have drug concentrations analyzed every 4th week, the price of this will be collected
48 weeks
Expenses for drugs
Tidsramme: 48 weeks

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
48 weeks
Drug persistency
Tidsramme: 48 weeks

number of patients switching to another treatment during the study
48 weeks
Disease flares
Tidsramme: 48 weeks

assessed by consumption of glucocorticoids or IBD-related surgery
48 weeks
Fatigue
Tidsramme: 48 weeks.

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.
48 weeks.
Disease impact on work productivity and performance of daily activities
Tidsramme: 48 weeks

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.
48 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Odense University Hospital

Etterforskere

  • Hovedetterforsker: Mark A Ainsworth, professor, DMSc, Odense University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. januar 2026

Primær fullføring (Antatt)

30. desember 2027

Studiet fullført (Antatt)

30. november 2028

Datoer for studieregistrering

Først innsendt

7. januar 2025

Først innsendt som oppfylte QC-kriteriene

22. januar 2025

Først lagt ut (Faktiske)

23. januar 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 32844
  • 2024-517123-39-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

will become available approximately March 2028 and will be available for at least 5 years

Tilgangskriterier for IPD-deling

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)

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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