Fluorescence imaging of a drug for inflammatory bowel disease
Investigating the Safety, Feasibility, and Optimal Dose of Risankizumab-800CW for Visualizing Drug Targeting in Inflammatory Bowel Disease
This study is testing a special version of a drug for inflammatory bowel disease to see how well it targets the right areas in the body and to find the best dose for patients.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | risankizumab |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06606808 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a fluorescently labeled version of risankizumab, a monoclonal antibody targeting IL23, to improve the understanding of drug targeting in patients with inflammatory bowel diseases such as Crohn's Disease and Ulcerative Colitis. The study aims to assess the safety and optimal dosing of risankizumab-800CW while utilizing fluorescence molecular imaging techniques to visualize and quantify local drug concentrations. By identifying predictors of treatment response, the study seeks to enhance the management of IBD patients who are candidates for risankizumab therapy.
Who should consider this trial
Good fit: Ideal candidates include adults with an established diagnosis of inflammatory bowel disease who are experiencing active disease and are eligible for risankizumab therapy.
Not a fit: Patients who are pregnant, breastfeeding, or have certain medical or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with inflammatory bowel disease by identifying those who are likely to respond to risankizumab.
How similar studies have performed: While the use of fluorescence imaging in drug targeting is a novel approach, similar studies have shown promise in enhancing treatment response prediction in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Wouter B Nagengast, MD, PharmD, PhD
- Email: w.b.nagengast@umcg.nl
- Phone: +31(0)503612620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.