Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease (NAVIGATE)

University Medical Center Groningen (UMCG)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Ulcerative Colitis (UC); Crohn Disease (CD)

Treatments: Drug: Risankizumab-800CW 15 mg; Drug: Risankizumab-800CW 4.5 mg; Drug: Risankizumab-800CW 25 mg; Drug: Risankizumab-800CW optimal dose

Study type: Interventional

Funder types: Other

Identifiers

NCT06606808

2024-515358-25-00 (EU Trial (CTIS) Number)

UMCG 20010

Details and patient eligibility

About

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).

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 > 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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 4 patient groups

4.5 mg risankizumab-800CW

Experimental group

Description:

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

Treatment:

Drug: Risankizumab-800CW 4.5 mg

15 mg risankizumab-800CW

Experimental group

Description:

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

Treatment:

Drug: Risankizumab-800CW 15 mg

25 mg risankizumab-800CW

Experimental group

Description:

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

Treatment:

Drug: Risankizumab-800CW 25 mg

14 weeks or more of risankizumab therapy and optimal dose risankizumab-800CW

Experimental group

Description:

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

Treatment:

Drug: Risankizumab-800CW optimal dose