Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606808
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating the Safety Feasibility and Optimal Dose of Risankizumab-800CW for Visualizing Drug Targeting in Inflammatory Bowel Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAVIGATE
Brief Summary:
Crohn39s 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None