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

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 1

Conditions: Colitis, Ulcerative; Crohn Disease

Treatments: Combination Product: Fluorescence molecular imaging procedure using vedolizumab-800CW with prior administration of unlabeled vedolizumab; Drug: Fluorescence molecular imaging procedure using vedolizumab-800CW; Other: Fluorescence molecular imaging procedure without prior administration of vedolizumab-800CW

Study type: Interventional

Funder types: Other

Identifiers

NCT04112212

NL69572.042.19

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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38 participants in 6 patient groups

No administration of vedolizumab-800CW

Other group

Description:

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

Treatment:

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

4.5 mg vedolizumab-800CW group

Experimental group

Description:

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

Treatment:

Drug: Fluorescence molecular imaging procedure using vedolizumab-800CW

15 mg vedolizumab-800CW group

Experimental group

Description:

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

Treatment:

Drug: Fluorescence molecular imaging procedure using vedolizumab-800CW

75 mg vedolizumab + 15 mg vedolizumab-800CW group

Experimental group

Description:

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

Treatment:

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

300mg vedolizumab + 15mg vedolizumab-800CW group

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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