NCT06606808RecruitingPhase 1/2
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
Investigating the Safety, Feasibility, and Optimal Dose of Risankizumab-800CW for Visualizing Drug Targeting in Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 5 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. Primary non-response to risankizumab is high in both CD and UC. Currently, there are no predictors of response to risankizumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of risankizumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled risankizumab (risankizumab-800CW). This study aims to assess the safety and the optimal dose of risankizumab-800CW to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 10 Sept 2024
- Start date
- Nov 2024
- Primary completion date
- Aug 2025
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06606808
- EU CT number
- 2024-515358-25-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 18
- From Nov 2024 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior anti-IL23-specific therapy (IL23/IL12 combination therapy is not an exclusion criteria)
Other illness
- 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)
- 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)
Age
- 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
- 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
Other
- A female study patient who is pregnant or provides breastfeeding
- A female study patient who is pregnant or provides breastfeeding
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.