Crohn'sUCRecruiting
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
Phase 1 / Phase 2 · Testing Risankizumab-800CW 4.5 mg, Risankizumab-800CW 15 mg and Risankizumab-800CW 25 mg · 1 site · University Medical Center Groningen
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Risankizumab-800CW 4.5 mg (a drug), Risankizumab-800CW 15 mg (a drug), Risankizumab-800CW 25 mg (a drug) and Risankizumab-800CW optimal dose (a drug). Condition(s) listed: Ulcerative Colitis (UC) and Crohn Disease (CD).
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 8 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 18 participants are expected to take part.
- Start date: 2024-11-08.
- Main results expected around 2025-08 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Netherlands.
Main thing being measured
- Determine the safety of risankizumab-800CW in IBD (2-3 days after administration (day of FME procedure))
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC); Crohn Disease (CD) |
| Lead sponsor | University Medical Center Groningen |
| Enrollment | 18 (estimated) |
| Start date | 2024-11-08 |
| Primary completion (est.) | 2025-08 |
| First posted | 2024-09-23 |
| Last updated | 2025-03-05 |
| Official title | Investigating the Safety, Feasibility, and Optimal Dose of Risankizumab-800CW for Visualizing Drug Targeting in Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT06606808 |
Interventions
- Risankizumab-800CW 4.5 mg (Drug)
Risankizumab-800CW will be administered intravenously. 2-3 days later, a Fluorescence Molecular Imaging procedure will be performed to enable the visualisation and detection of fluorescence signals. - Risankizumab-800CW 15 mg (Drug)
Risankizumab-800CW will be administered intravenously. 2-3 days later, a Fluorescence Molecular Imaging procedure will be performed to enable the visualisation and detection of fluorescence signals. - Risankizumab-800CW 25 mg (Drug)
Risankizumab-800CW will be administered intravenously. 2-3 days later, a Fluorescence Molecular Imaging procedure will be performed to enable the visualisation and detection of fluorescence signals. - Risankizumab-800CW optimal dose (Drug)
Risankizumab-800CW will be administered intravenously. 2-3 days later, a Fluorescence Molecular Imaging procedure will be performed to enable the visualisation and detection of fluorescence signals.
Full eligibility criteria (from the record)
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)
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Groningen | Groningen | Netherlands | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.