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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-04

Study Completion Date

2023-01-01

Brief Summary

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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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Detailed Description

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Conditions

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Crohn Disease Colitis, Ulcerative

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

38 IBD patients were included in the study.

1. Dose escalation, including 3 dose groups.
2. Adding a blocking dose.
3. Patients included after \>14 weeks of therapy

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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No administration of vedolizumab-800CW

Patients did not receive vedolizumab-800CW but underwent a Fluorescence molecular imaging procedure to serve as a control group and compare results with patients receiving the tracer

Group Type OTHER

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

Intervention Type OTHER

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

4.5 mg vedolizumab-800CW group

Patients received 4.5 mg vedolizumab-800CW and subsequently underwent a Fluorescence molecular imaging procedure

Group Type EXPERIMENTAL

Fluorescence molecular imaging procedure using vedolizumab-800CW

Intervention Type 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.

15 mg vedolizumab-800CW group

Patients received 15 mg vedolizumab-800CW and subsequently underwent a Fluorescence molecular imaging procedure

Group Type EXPERIMENTAL

Fluorescence molecular imaging procedure using vedolizumab-800CW

Intervention Type 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.

75 mg vedolizumab + 15 mg vedolizumab-800CW group

Patients received 75mg vedolizumab + 15 mg vedolizumab-800CW and subsequently underwent a Fluorescence molecular imaging procedure

Group Type EXPERIMENTAL

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

Intervention Type 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.

300mg vedolizumab + 15mg vedolizumab-800CW group

Patients received 300mg vedolizumab + 15 mg vedolizumab-800CW and subsequently underwent a Fluorescence molecular imaging procedure

Group Type EXPERIMENTAL

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

Intervention Type 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.

> 14 weeks of vedolizumab therapy + 15 mg vedolizumab-800CW group

Patients received 300mg vedolizumab + 15 mg vedolizumab-800CW after \>14 weeks vedolizumab therapy and subsequently underwent a Fluorescence molecular imaging procedure

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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Fluorescence molecular imaging procedure using vedolizumab-800CW

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.

Intervention Type DRUG

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

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

Intervention Type OTHER

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

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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Control group

Eligibility Criteria

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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.