Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease
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).
Timeline
- Start
- 2024-03
- Primary completion
- 2024-12
- Completion
- 2025-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adalimumab-680LT | Monoclonal antibody | 4.5 mg | Intravenous |
| Subject | Adalimumab-680LT | Monoclonal antibody | 15 mg | Intravenous |
| Subject | Adalimumab-680LT | Monoclonal antibody | 25 mg | Intravenous |