Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease

Sponsor
University Medical Center Groningen
Study ID
NCT06606808
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Crohn Disease (CD)
  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Nov 8, 2024
Status verified
Mar 2025
Primary completion
Aug 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: 4.5 mg risankizumab-800CW
    Patients receive 4.5 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure
  • Experimental: 15 mg risankizumab-800CW
    Patients receive 15 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure
  • Experimental: 25 mg risankizumab-800CW
    Patients receive 25 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure
  • Experimental: 14 weeks or more of risankizumab therapy and optimal dose risankizumab-800CW
    Patients who are treated with risankizumab for at least 14 weeks are enrolled in this arm. This can be patients who already joined in the dose finding part of the study or new patients. These patients will receive the optimal dose risankizumab-800CW and will undergo aFluorescence Molecular Imaging procedure

Primary Outcome Measure

Determine the safety of risankizumab-800CW in IBD [ Time Frame: 2-3 days after administration (day of FME procedure) ]

Central Contacts

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