Clinical trial NCT06606808: Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
Official title: Investigating the Safety, Feasibility, and Optimal Dose of Risankizumab-800CW for Visualizing Drug Targeting in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Ulcerative Colitis (UC)
Crohn Disease (CD)
Keywords: Fluorescence Molecular Endoscopy
Inflammatory Bowel Disease
Risankizumab-800CW
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: Crohn\&#39;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 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 \&gt; 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 outcomes:
measure: Determine the safety of risankizumab-800CW in IBD
timeFrame: 2-3 days after administration (day of FME procedure)
measure: Blood pressure
timeFrame: Five minutes before, and five and sixty minutes after tracer administration
measure: Heart rate
timeFrame: Five minutes before, and five and sixty minutes after tracer administration
measure: Temperature
timeFrame: Five minutes before, and five and sixty minutes after tracer administration
measure: Investigate the feasibility of using ex vivo FMI to detect risankizumab-800CW
timeFrame: 12 months
measure: Investigate the feasibility of using FME to detect risankizumab-800CW signals_1
timeFrame: 12 months
measure: Investigate the feasibility of using FME to detect risankizumab-800CW signals_2
timeFrame: 12 months
measure: Investigate the feasibility of using FME to detect risankizumab-800CW signals_3
timeFrame: 12 months
measure: Determining the optimal imaging dose of risankizumab-800CW
timeFrame: 12 months
Secondary outcomes:
measure: Investigate a potential correlation of in vivo fluorescence signal intensities and target saturation to clinical response/remission after 14 weeks of risankizumab therapy regimen in patients with IBD
timeFrame: 12 months
measure: Investigate a potential correlation of ex vivo fluorescence signal intensities and target saturation to clinical response/remission after 14 weeks of risankizumab therapy regimen in patients with IBD
timeFrame: 12 months
measure: Quantify the fluorescence signals of the tracer in vivo by using single-fiber reflectance/single-fiber fluorescence (MDSFR/SFF) spectroscopy and correlate these measurements to tracer dose, in vivo fluorescence intensities and inflammation severity
timeFrame: 12 months
measure: To correlate ex vivo fluorescence signals to inflammation severity and tracer dose based on histopathological examination inside the obtained biopsies
timeFrame: 12 months
measure: To assess tracer stability, tracer distribution and tracer concentration, and to identify the composition of immune cells ex vivo to learn more about risankizumab mucosal target cells
timeFrame: 12 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: