Actively Recruiting
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
Led by University Medical Center Groningen · Updated on 2025-03-05
18
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of inflammatory bowel disease (IBD)
- Clinically or biochemically active bowel disease as defined by scoring indices or fecal calprotectin > 60 bcg/g (part A)
- Eligible for risankizumab therapy (part A)
- Receiving risankizumab therapy for at least 14 weeks (part B)
- Minimum age of 18 years
- Written informed consent provided
- Clinical indication for an endoscopic procedure
You will not qualify if you...
- Female participants who are pregnant or breastfeeding
- Female participants of premenopausal age not using reliable contraception at the time of risankizumab-800CW administration and for the following 10 weeks
- Medical or psychiatric conditions that impair ability to give informed consent
- Prior anti-IL23-specific therapy (except IL23/IL12 combination therapy) (part A only)
- Active extra gastrointestinal manifestations of Crohn's disease such as uveitis or pyoderma gangrenosum at vital locations
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands, 9713GZ
Actively Recruiting
Research Team
W
Wouter B Nagengast, MD, PharmD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
4
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