Investigating the Safety, Feasibility, and Optimal Dose of Risankizumab-800CW for Visualizing Drug Targeting in Inflammatory Bowel Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Determine the safety of risankizumab-800CW in IBD
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
4.5 mg risankizumab-800CW
Patients receive 4.5 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure
干预措施: Risankizumab-800CW 4.5 mg (Drug)
15 mg risankizumab-800CW
Patients receive 15 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure
干预措施: Risankizumab-800CW 15 mg (Drug)
25 mg risankizumab-800CW
Patients receive 25 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure
干预措施: Risankizumab-800CW 25 mg (Drug)
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
干预措施: Risankizumab-800CW optimal dose (Drug)
结局指标
主要结局
Determine the safety of risankizumab-800CW in IBD
时间窗: 2-3 days after administration (day of FME procedure)
Evaluating possible (severe) adverse events (SAE and AEs)
Blood pressure
时间窗: Five minutes before, and five and sixty minutes after tracer administration
Systolic and diastolic in millimeters of mercure (mmHg)
Heart rate
时间窗: Five minutes before, and five and sixty minutes after tracer administration
Beats per minute
Temperature
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 12 months
The optimal dose will be based on the risankizumab-800CW signals during FME and ex vivo FMI
次要结局
- 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(12 months)
- 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(12 months)
- 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(12 months)
- To correlate ex vivo fluorescence signals to inflammation severity and tracer dose based on histopathological examination inside the obtained biopsies(12 months)
- 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(12 months)