NIR FME of Labelled Vedolizumab to Elucidate the Mechanism of Action and Predicting Response in IBD Patients.
Status:
Recruiting
Trial end date:
2021-12-30
Target enrollment:
Participant gender:
Summary
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 near-infrared fluorescence
molecular endoscopy (NIR-FME), spectroscopy and confocal laser endomicroscopy (CLE). By
gaining insight into local vedolizumab concentrations, drug distribution and by discovering
target cells, we expect to gain insight into the mechanism of action, gather data with which
to optimize vedolizumab dosing, and to learn to predict therapy response in the individual
patient.