Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Sep 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new version of the medication risankizumab, called risankizumab-800CW, to see how well it works in treating patients with inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis. The goal is to understand how the drug targets areas of inflammation in the bowel, which could help predict how well patients will respond to treatment. Researchers will also be looking at the safety of this new version of the drug and the best dose to use.

To participate in this trial, you must be at least 18 years old and have a diagnosis of IBD with active symptoms. If you are already on risankizumab treatment, you can join as well, but you must have been receiving it for at least 14 weeks. Participants will undergo endoscopic procedures, which allow doctors to see inside the bowel, and they will need to provide written consent to join the study. It's important to note that pregnant women or those who are breastfeeding cannot participate, and there are certain health conditions that could exclude some patients. If you decide to take part, you can help contribute to important research that may improve treatments for IBD in the future.

Gender

ALL

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 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)