RecruitingPhase 1Phase 2NCT06606808

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

Sponsor

University Medical Center Groningen

Enrollment

18 participants

Start Date

Nov 8, 2024

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis (UC)Crohn Disease (CD)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new imaging technique that uses a fluorescent dye attached to the drug risankizumab to visualize inflammation inside the intestines during a colonoscopy in people with inflammatory bowel disease (IBD). The goal is to see if this technique can better identify areas of active inflammation to guide treatment. **You may be eligible if...** - You are 18 years or older with a confirmed IBD diagnosis (Crohn's disease or ulcerative colitis) - For Part A: You have active disease and are eligible to start risankizumab therapy, and you have a clinical reason for an endoscopy - For Part B: You have already been on risankizumab therapy for at least 14 weeks and need a follow-up endoscopy **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are a premenopausal woman who is not using adequate contraception (for Part A) - You have conditions that make risankizumab unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRisankizumab-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.

DRUGRisankizumab-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.

DRUGRisankizumab-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.

DRUGRisankizumab-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.