Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
Summary
Crohn\'s Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Risankizumab is a human monoclonal antibody against IL23 p19, part of a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to its receptor. Primary non-response to risankizumab is high in both CD and UC. Currently, there are no predictors of response to risankizumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of risankizumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled risankizumab (risankizumab-800CW). This study aims to assess the safety and the optimal dose of risankizumab-800CW 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
- 2024-11-08
- Primary completion
- 2025-08
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risankizumab-800CW | Monoclonal antibody | 4.5 mg | Intravenous |
| Subject | Risankizumab-800CW | Monoclonal antibody | 15 mg | Intravenous |
| Subject | Risankizumab-800CW | Monoclonal antibody | 25 mg | Intravenous |