Risankizumab-800CW 4.5 mg: 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: 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: 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: 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.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Determine the safety of risankizumab-800CW in IBD — 2-3 days after administration (day of FME procedure) Evaluating possible (severe) adverse events (SAE and AEs)
Blood pressure — Five minutes before, and five and sixty minutes after tracer administration Systolic and diastolic in millimeters of mercure (mmHg)
Heart rate — Five minutes before, and five and sixty minutes after tracer administration Beats per minute
Temperature — Five minutes before, and five and sixty minutes after tracer administration Degrees Celsius
Investigate the feasibility of using ex vivo FMI to detect risankizumab-800CW — 12 months Evaluating the performance of ex vivo FMI for detecting risankizumab-800CW signals. This evaluation will be based on mean fluorescence intensities (MFIs) of biopsies and fluorescence/light sheet microscopy.
Investigate the feasibility of using FME to detect risankizumab-800CW signals_1 — 12 months Evaluating the performance of FME for detecting risankizumab-800CW signals. This evaluation will be based on MDSFR/SFF measurements.
Investigate the feasibility of using FME to detect risankizumab-800CW signals_2 — 12 months Evaluating the performance of FME for detecting risankizumab-800CW signals. This evaluation will be based on a visual evaluation during FME (visible signal yes/no).
Investigate the feasibility of using FME to detect risankizumab-800CW signals_3 — 12 months Evaluating the performance of FME for detecting risankizumab-800CW signals. This evaluation will be based on TBR/CNR calculations.
Determining the optimal imaging dose of risankizumab-800CW — 12 months The optimal dose will be based on the risankizumab-800CW signals during FME and ex vivo FMI
Trial sites (1)
Facility
City
Region
Status
University Medical Center Groningen
Groningen
Netherlands
Recruiting
More University Medical Center Groningen trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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