Ulcerative Colitis (UC)Phase 1/2NAVIGATENCT06606808
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
A Phase 1/2 study testing Risankizumab-800CW 4.5 mg, Risankizumab-800CW 15 mg and Risankizumab-800CW 25 mg in people with Ulcerative Colitis (UC) and Crohn Disease (CD), run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC), Crohn Disease (CD)
- What is being tested?
- Risankizumab-800CW 4.5 mg, Risankizumab-800CW 15 mg and Risankizumab-800CW 25 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Nov 2024to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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)
- A female study patient who is pregnant or provides breastfeeding
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713GZ
Wouter B Nagengast, MD, PharmD, PhD, +31(0)503612620, w.b.nagengast@umcg.nl
About this study
Official title: Investigating the Safety, Feasibility, and Optimal Dose of Risankizumab-800CW for Visualizing Drug Targeting in Inflammatory Bowel Disease
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)
- Being tested
- Risankizumab-800CW 4.5 mg, Risankizumab-800CW 15 mg, Risankizumab-800CW 25 mg, Risankizumab-800CW optimal dose
- Keywords
- Fluorescence Molecular Endoscopy, Inflammatory Bowel Disease, Risankizumab-800CW
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risankizumab-800CW 4.5 mgDrug
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 mgDrug
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 mgDrug
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 doseDrug
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 group | Role | What they receive |
|---|---|---|
| 4.5 mg risankizumab-800CW | Experimental | Patients receive 4.5 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure Receives: Drug: Risankizumab-800CW 4.5 mg |
| 15 mg risankizumab-800CW | Experimental | Patients receive 15 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure Receives: Drug: Risankizumab-800CW 15 mg |
| 25 mg risankizumab-800CW | Experimental | Patients receive 25 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure Receives: Drug: Risankizumab-800CW 25 mg |
| 14 weeks or more of risankizumab therapy and optimal dose risankizumab-800CW | Experimental | 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 Receives: Drug: Risankizumab-800CW optimal dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety of risankizumab-800CW in IBD
Evaluating possible (severe) adverse events (SAE and AEs)
Measured: 2-3 days after administration (day of FME procedure)
Blood pressure
Systolic and diastolic in millimeters of mercure (mmHg)
Measured: Five minutes before, and five and sixty minutes after tracer administration
Heart rate
Beats per minute
Measured: Five minutes before, and five and sixty minutes after tracer administration
Temperature
Degrees Celsius
Measured: Five minutes before, and five and sixty minutes after tracer administration
Investigate the feasibility of using ex vivo FMI to detect risankizumab-800CW
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.
Measured: 12 months
Investigate the feasibility of using FME to detect risankizumab-800CW signals_1
Evaluating the performance of FME for detecting risankizumab-800CW signals. This evaluation will be based on MDSFR/SFF measurements.
Measured: 12 months
Investigate the feasibility of using FME to detect risankizumab-800CW signals_2
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).
Measured: 12 months
Investigate the feasibility of using FME to detect risankizumab-800CW signals_3
Evaluating the performance of FME for detecting risankizumab-800CW signals. This evaluation will be based on TBR/CNR calculations.
Measured: 12 months
Determining the optimal imaging dose of risankizumab-800CW
The optimal dose will be based on the risankizumab-800CW signals during FME and ex vivo FMI
Measured: 12 months
Secondary outcomes (5)
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
Evaluation of the potential correlation in vivo will be based on in vivo fluorescence images and the MDSFR/SFF measurements before and after at least 14 weeks of risankizumab treatment
Measured: 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
Evaluation of the potential correlation ex vivo will be based on MFIs of biopsies, fluorescence microscopy results, and tracer concentrations inside biopsies before and after at least 14 weeks of risankizumab treatment
Measured: 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
Quantification of MDSFR/SFF measurements in inflamed tissue compared to measurements in non-inflamed tissue. Positive correlation between MDSFR/SFF measurements and dose/inflammation severity?
Measured: 12 months
To correlate ex vivo fluorescence signals to inflammation severity and tracer dose based on histopathological examination inside the obtained biopsies
Histologically ascertained tissue types (qualitative): Normal (non-inflamed) ileal, colon and rectal tissue inflamed ileum, colon and rectum tissue Random ''high-fluorescent'' tissue Random ''Non-fluorescent'' tissue
Measured: 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
Fluorescence (confocal) microscopy with additional use of immune panels and spatial transcriptomics analysis (before and after at least 14 weeks of risankizumab treatment). Measurements of the risankizumab-800CW concentration by light-sheet microscopy after tissue clearing, insights in risankizumab target cells and presence of immune cells inside the biopsies and blood samples by flow cytometry and assessment of tracer stability by Western Blot
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start8 Nov 2024
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606808
- Sponsor's protocol ID
- UMCG 20010
- Other IDs
- 2024-515358-25-00
- Acronym
- NAVIGATE
- Status last verified
- Mar 2025
- First submitted
- 10 Sep 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Safety, Feasibility, and Optimal Dose of Risankizumab-800CW for Visualizing Drug Targeting in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06606808
- Acronym / sponsor ID
- NAVIGATE / UMCG 20010
- Conditions
- Ulcerative Colitis (UC), Crohn Disease (CD)
- Keywords
- Fluorescence Molecular Endoscopy, Inflammatory Bowel Disease, Risankizumab-800CW
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 4.5 mg risankizumab-800CW | Experimental | Drug: Risankizumab-800CW 4.5 mgPatients receive 4.5 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure |
| 15 mg risankizumab-800CW | Experimental | Drug: Risankizumab-800CW 15 mgPatients receive 15 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure |
| 25 mg risankizumab-800CW | Experimental | Drug: Risankizumab-800CW 25 mgPatients receive 25 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure |
| 14 weeks or more of risankizumab therapy and optimal dose risankizumab-800CW | Experimental | Drug: Risankizumab-800CW optimal dosePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risankizumab-800CW 4.5 mgRisankizumab-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. | Drug | 4.5 mg risankizumab-800CW |
| Risankizumab-800CW 15 mgRisankizumab-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. | Drug | 15 mg risankizumab-800CW |
| Risankizumab-800CW 25 mgRisankizumab-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. | Drug | 25 mg risankizumab-800CW |
| Risankizumab-800CW optimal doseRisankizumab-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. | Drug | 14 weeks or more of risankizumab therapy and optimal dose risankizumab-800CW |
Primary outcome
Determine the safety of risankizumab-800CW in IBD
Time frame: 2-3 days after administration (day of FME procedure)
Evaluating possible (severe) adverse events (SAE and AEs)
Blood pressure
Time frame: Five minutes before, and five and sixty minutes after tracer administration
Systolic and diastolic in millimeters of mercure (mmHg)
Heart rate
Time frame: Five minutes before, and five and sixty minutes after tracer administration
Beats per minute
Temperature
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
The optimal dose will be based on the risankizumab-800CW signals during FME and ex vivo FMI
5 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 12 months
To correlate ex vivo fluorescence signals to inflammation severity and tracer dose based on histopathological examination inside the obtained biopsies
Time frame: 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
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Risankizumab-800CW 4.5 mg, Risankizumab-800CW 15 mg and Risankizumab-800CW 25 mg in people with Ulcerative Colitis (UC) and Crohn Disease (CD), run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wouter B Nagengast, MD, PharmD, PhD (+31(0)503612620, w.b.nagengast@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the safety of risankizumab-800CW in IBD (time frame: 2-3 days after administration (day of FME procedure)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.