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NCT Number: NCT04112212

Using Vedolizumab-800CW to Gain Insight Into Local Drug Distribution and Mucosal Target Cells in IBD Patients

Summary Vision Study

Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic idiopathic inflammatory bowel diseases (IBD). Vedolizumab is a humanized monoclonal antibody against α4β7 integrin, capable of blocking the migration of several immune cells across endothelium expressing MAdCAM-1. Vedolizumab is expensive and primary non-response is high in both CD and UC. Currently there are no predictors of response to vedolizumab and the actual mechanism of action has not yet been elucidated. To clarify the mechanism of action and gain better understanding of the high primary non-response rates, the University Medical Center Groningen (UMCG) developed a tracer fluorescently labeling vedolizumab. This study aims to gain insight into vedolizumab distribution and concentrations in the gut. The current study aims to identify the vedolizumab target cells in the inflamed gut mucosa using quantitative fluorescence molecular imaging (FMI). By gaining insight into local vedolizumab concentrations, drug distribution and by discovering target cells, we expect to gain insight into the mechanism of action of vedolizumab.

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Key information

Conditions

Crohn Disease Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Established diagnosis of IBD, or Ulcerative Colitis (UC) or Crohn's Disease (CD).
  • Vedolizumab naïve and eligible for vedolizumab treatment.
  • Age: 18 years or older.
  • Written informed consent.

Exclusion criteria

  • Prior vedolizumab treatment
  • Vedolizumab contraindicated as therapy
  • Pregnancy or breast feeding.
  • Patients younger than 18 years old

Treatment and study plan

Fluorescence molecular imaging procedure using vedolizumab-800CW

Drug

First vedolizumab-800CW was administered intravenously. 2-4 days later a fluorescence molecular imaging procedure was performed to enable the visualization and detection of fluorescence signals.

Fluorescence molecular imaging procedure without prior administration of vedolizumab-800CW

Other

Fluorescence molecular imaging was performed to enable the visualization and detection of fluorescence signals.

Other names: Control group

Fluorescence molecular imaging procedure using vedolizumab-800CW with prior administration of unlabeled vedolizumab

Combination Product

Patients on vedolizumab therapy received vedolizumab-800CW iv or patients first received an unlabeled dose of vedolizumab prior to the iv administration of vedolizumab-800CW. 2-4 days later a fluorescence molecular imaging procedure was performed to enable the visualization and detection of fluorescence signals.

Primary outcomes

  1. Fluorescent signal in patients with IBD

    Time frame: After 18 months when study is completed.

    Quantification of fluorescent signal after a microdose of vedolizumab-800CW in inflamed and non-inflamed tissue in patients with IBD.

Secondary outcomes

  1. Safety of Vedolizumab-800CW in patients with IBD

    Time frame: Interim analysis after 30 weeks (at least 5 patients included). Complete data of all patients when study is completed. Individual patients were followed up for 1 week after vedolizumab-800CW injection for AE's, SAE's and SUSAR's.

    Collect safety data of vedolizumab-800CW. Checking vital parameters and adverse events caused by the drug or intervention.

    Register and analyze all AE's, SAE's and SUSAR's caused by vedolizumab-800CW.

  2. Semi-quantifying fluorescent signals in patients with IBD

    Time frame: Interim analysis after 30 weeks (at least 5 patients included). Complete data after 18 months when study is completed.

    Semi-quantification of the ex vivo mean fluorescent intensity signal of vedolizumab-800CW in biopsies by calculating the mean fluorescence intensity (FImean) of biopsy images generated with a fluorescence flatbed scanner

  3. FMI ex vivo analysis to detect target cells

    Time frame: After 18 months when study is completed.

    To evaluate the degree of in vivo fluorescence intensity for differences in severity of inflammation and quantify the in vivo NIR fluorescent signal of vedolizumab-800CW using the spectroscopy probe and compare this to the ex vivo fluorescent signal levels in the biopsies taken (immunohistochemistry, RNA and DNA analysis).

  4. Distribution of Vedolizumab in the inflamed gut

    Time frame: After 18 months when study is completed.

    To assess the (sub-)cellular location of vedolizumab-800CW microscopically.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Using Fluorescently Labeled Vedolizumab to Visualize Local Drug Distribution During Colonoscopy and Identify Mucosal Target Cells in Patients With Inflammatory Bowel Disease

Acronym: VISION

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 2, 2019
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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