Fluorescence imaging of a drug for inflammatory bowel disease
Official title: Investigating the Safety, Feasibility, and Optimal Dose of Risankizumab-800CW for Visualizing Drug Targeting in Inflammatory Bowel Disease
Run by University Medical Center Groningen · NCT06606808 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | risankizumab |
| Locations | 1 site (Groningen) |
| Status | Recruiting |
| Started | November 8, 2024 |
| Main results expected | August 2025 |
| Study ends | December 2025 |
| Registry record updated | March 5, 2025 |
| Trial ID | NCT06606808 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have certain medical or psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Familial IBD Early Risk
This study tests whether clinical, environmental, and immune factors in first-degree relatives of people with Crohn’s disease or ulcerative colitis can predict who will develop IBD.
-
Biomarker Discovery and Validation Platform for Inflammatory Bowel Disease
Researchers are testing biomarker models to see if they can measure and predict inflammation and treatment response in people with Crohn's disease, ulcerative colitis, or related IBD.
-
Wearable data to spot IBD flareups in people with ulcerative colitis or Crohn's disease
This study tests whether heart‑rate variability from participants’ own wearables can help predict IBD flares.
-
Individualizing Anti-TNF Therapy in IBD
This study tests whether genetic markers can predict which anti-TNF–naïve IBD patients will respond to their first anti-TNF treatment.
-
LRG levels and IBD activity in European patients
This study will test whether Leucine-rich α2-glycoprotein (LRG) levels reflect disease activity in adults with Crohn’s or ulcerative colitis who are undergoing routine endoscopy in Europe.
-
CEDUR — German inflammatory bowel disease registry
This registry collects real-world health and treatment information from adults with Crohn's disease, ulcerative colitis, or indeterminate colitis in Germany to see how care, effectiveness, safety, and costs play out in routine practice.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.