Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
Recruiting
Phase 1
Phase 2
Interventional Study
Ulcerative Colitis (UC)
Crohn Disease (CD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 18 (estimated)
- Sponsor
- University Medical Center Groningen · Other
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About This Trial
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 risankizum…
Trial Locations
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Eligibility Criteria
Inclusion Criteria for part A:
* Established IBD diagnosis
* Active disease: clinically active disease of the bowel is defined clinically as at least mild activity using dedicated scoring indices or biochemically active disease as defined by a fecal calprotectin \> 60 μg/g
* Patients must be eli…
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