NCT06117423

Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease

Investigating the Safety, Feasibility, and Optimal Dose of Fluorescently Labeled Adalimumab-680LT for Visualizing Drug Targeting in Inflammatory Bowel Diseases

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Adalimumab is a human monoclonal antibody against TNF-alpha, a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to the TNF receptors. Primary non-response to adalimumab is high in both CD and UC. Currently, there are no predictors of response to adalimumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of adalimumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled adalimumab (adalimumab-680LT). This study aims to assess the safety and the optimal dose of adalimumab-680LT to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).

Conditions

• Crohn Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Adalimumab-680LT	First, adalimumab-680LT was administered intravenously. 2-3 days later, a Fluorescence Molecular Imaging procedure was performed to enable the visualisation and detection of fluorescence signals.
OTHER	Control	Fluorescence Molecular Imaging was performed to enable the visualisation and detection of fluorescence signals.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2023-11-07
• Last updated: 2024-03-12

Locations

1 site across 1 country: Netherlands