NCT04112212: VISION

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

Completed Phase 1 Last updated 16 April 2024

What this trial tests

Phase 1 trial testing Fluorescence molecular imaging procedure using vedolizumab-800CW in Crohn Disease in 38 participants. Completed in 1 January 2023.

Timeline

4 November 2020

Primary endpoint
1 October 2022

1 January 2023

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	other
Enrollment	38
Start date	4 November 2020
Primary completion	1 October 2022
Estimated completion	1 January 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Fluorescence molecular imaging procedure using vedolizumab-800CW — full drug profile →
• Fluorescence molecular imaging procedure without prior administration of vedolizumab-800CW
• Fluorescence molecular imaging procedure using vedolizumab-800CW with prior administration of unlabeled vedolizumab

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →
• Colitis, Ulcerative — all drugs for Colitis, Ulcerative →

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Crohn Disease or Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeted optical fluorescence imaging: a meta-narrative review and future perspectives.
   Schouw HM, Huisman LA, Janssen YF, Slart RHJA, et al · · 2021 · cited 48× · PMID 34633509 · DOI 10.1007/s00259-021-05504-y
2. Fluorescently labelled vedolizumab to visualise drug distribution and mucosal target cells in inflammatory bowel disease.
   Gabriëls RY, van der Waaij AM, Linssen MD, Dobosz M, et al · · 2024 · cited 11× · PMID 38580386 · DOI 10.1136/gutjnl-2023-331696