Status:
RECRUITING
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
Lead Sponsor:
University Medical Center Groningen
Conditions:
Ulcerative Colitis (UC)
Crohn Disease (CD)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 t...
Eligibility Criteria
Inclusion
- 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 eligible for risankizumab therapy
- Minimum age of 18 years
- Written informed consent
- Clinical indication for an endoscopic procedure
- Inclusion Criteria for part B:
- Established IBD diagnosis
- Patients must be on risankizumab therapy for at least 14 weeks
- Minimum age of 18 years
- Written informed consent
- Clinical indication for an endoscopic procedure
- Exclusion Criteria for part A:
- A female study patient who is pregnant or provides breastfeeding
- A female study patient of premenopausal age who does not use any reliable form of contraception at the time of risankizumab-800CW administration and the following 10 weeks
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Prior anti-IL23-specific therapy (IL23/IL12 combination therapy is not an exclusion criteria)
- Active extra gastrointestinal manifestations of Crohn's disease (e.g. uveitis or pyoderma gangrenosum at vital locations)
- Exclusion Criteria for part B:
- A female study patient who is pregnant or provides breastfeeding
- A female study patient of premenopausal age who does not use any reliable form of contraception at the time of risankizumab-800CW administration and the following 10 weeks
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Active extra gastrointestinal manifestations of Crohn's disease (e.g. uveitis or pyoderma gangrenosum at vital locations)
Exclusion
Key Trial Info
Start Date :
November 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06606808
Start Date
November 8 2024
End Date
December 1 2025
Last Update
March 5 2025
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713GZ