Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease

NCT ID: NCT06606808

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-08
• Study Completion Date: 2025-12-31

Brief 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).

Conditions

Ulcerative Colitis (UC); Crohn Disease (CD)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

4.5 mg risankizumab-800CW

Patients receive 4.5 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure

Group Type: EXPERIMENTAL

Risankizumab-800CW 4.5 mg

Intervention Type: 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.

15 mg risankizumab-800CW

Patients receive 15 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure

Group Type: EXPERIMENTAL

Risankizumab-800CW 15 mg

Intervention Type: 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.

25 mg risankizumab-800CW

Patients receive 25 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure

Group Type: EXPERIMENTAL

Risankizumab-800CW 25 mg

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Risankizumab-800CW optimal dose

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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)

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Wouter B Nagengast, MD, PharmD, PhD

Role: CONTACT

w.b.nagengast@umcg.nl

+31(0)503612620

Facility Contacts

Wouter B Nagengast, MD, PharmD, PhD

Role: primary

w.b.nagengast@umcg.nl

+31(0)503612620

Other Identifiers

2024-515358-25-00

Identifier Type: CTIS

Identifier Source: secondary_id

UMCG 20010

Identifier Type: -

Identifier Source: org_study_id