Ulcerative Colitis (UC)Phase 1/2VOYAGERNCT07258641
Fluorescence Imaging of Adalimumab-680LT and Risankizumab-800CW in Inflammatory Bowel Disease
A Phase 1/2 study testing 25mg adalimumab-680LT and 15/25 mg risankizumab-800CW, Adalimumab-680LT 25mg and Risankizumab-800CW 15 mg/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
Inflammatory bowel diseases (IBD) are chronic relapsing inflammatory disorders of the gastrointestinal tract affecting 2.5 million patients in Europe alone. The majority of newly diagnosed patients are in adolescence or early adulthood and in the midst of their family life, career, and social development. 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?
- 25mg adalimumab-680LT and 15/25 mg risankizumab-800CW, Adalimumab-680LT 25mg and Risankizumab-800CW 15 mg/25 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jan 2026to 1 Apr 2028
- 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
- Patients eligible for inclusion meet all of the following criteria:
- Established IBD diagnosis (UC or CD).
- Active disease: clinically active disease of the bowel is defined 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 adalimumab or risankizumab therapy.
- Age of 18 years
- Written informed consent
Show all 9Show fewer
- Clinical indication for an endoscopic procedure
- For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs, or are less than 2 years postmenopausal:
- A negative pregnancy test (urine or blood test) must be available.
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 adalimumab-680LT and/or risankizumab 800CW administration
- 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)
- Prior anti-TNFα therapy in the last 6 weeks before inclusion
- Previous treatment with adalimumab and detectable anti-adalimumab antibody levels
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
University Medical Center Groningen
Groningen, Provincie Groningen, 9713GZ
Wouter B Nagengast, MD, PharmD, PhD, Professor, +31(0)503612620, w.b.nagengast@umcg.nl
About this study
Official title: Dual Wavelength Fluorescence Imaging Using Fluorescently Labelled Adalimumab and Risankizumab for Visualizing Drug Targeting in Inflammatory Bowel Diseases
Inflammatory bowel diseases (IBD) are chronic relapsing inflammatory disorders of the gastrointestinal tract affecting 2.5 million patients in Europe alone. The majority of newly diagnosed patients are in adolescence or early adulthood and in the midst of their family life, career, and social development.
IBD comes with significant morbidity and complex treatment strategies and is associated with a high social burden and medical costs. Besides other factors, the pathogenesis of IBD is attributed to proinflammatory cytokine tumor necrosis factor α (TNFα) and Interleukin 23 (IL-23). Adalimumab, a human monoclonal anti-TNF antibody, and risankizumab, a humanized monoclonal anti-IL-23 antibody, are used to treat patients with moderate to severely active IBD. However, IBD patients often only partially respond to such biological immunomodulating therapies, resulting in high primary nonresponse (30-60%) and loss of response over time (48-58%). The investigators are currently missing reliable tools for response prediction because the limitations of current technologies do not allow the visualization of the molecular phenotype or heterogeneity within patients. Therefore, patients are potentially exposed to a non-effective treatment and its potential side effects while clinical deterioration is ongoing. In addition, it remains completely unknown for most biologicals used for IBD therapy whether they reach their actual targets in the tissue and if a sufficient local concentration is present to achieve treatment response. To develop a predictive tool for assessment of therapeutic (non-)response to patients and gain insights into local drug concentrations in individual patients before initiating anti-TNF or anti-IL23 therapy, the University Medical Center Groningen (UMCG), fluorescently labeled adalimumab (adalimumab-680LT) and risankizumab (risankizumab-800CW) to visualize and quantify the labeled drugs in diseased tissue with dedicated optical fluorescence imaging systems. In previous studies, the investigators have proven that those tracers bind to TNFα/IL23 in the mucosa after intravenous injection and that the investigators can investigate the drug distribution in vivo due to the colocalization of the fluorescently labeled compound. The aim of this follow-up study is to assess the feasibility of simultaneous dual wavelength imaging of adalimumab-680LT and risankizumab-800CW at baseline and evaluate target saturation after at least 14 weeks of adalimumab or risankizumab therapy. The investigators will also use in vivo and ex vivo fluorescence molecular imaging (FMI) to visualize tracer target cells and the patient's molecular phenotype for potential treatment response prediction in IBD patients in the future.
Read more
The investigators will determine the feasibility of dual wavelengths molecular fluorescence imaging using the GMPproduced near-infrared fluorescent tracers adalimumab-680LT and risankizumab-800CW for visualizing medicine distribution in and ex vivo IBD patients with dedicated fluorescence imaging systems.
Furthermore, the investigators will evaluate TNF and IL23 target saturation after 14 weeks of adalimumab or risankizumab therapy and characterize the tissue microenvironment where the drug is abundant and identify potential drug target cells.
- Conditions
- Ulcerative Colitis (UC), Crohn Disease (CD)
- Being tested
- 25mg adalimumab-680LT and 15/25 mg risankizumab-800CW, Adalimumab-680LT 25mg, Risankizumab-800CW 15 mg/25 mg
- Keywords
- Fluorescence Molecular Endoscopy, Inflammatory Bowel Disease, Risankizumab-800CW, Adalimumab-680LT
- 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.
25mg adalimumab-680LT and 15/25 mg risankizumab-800CWDrug
Adalimumab-680LT and 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 dual-wavelength fluorescence signals.
Adalimumab-680LT 25mgDrug
Adalimumab-680LT 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/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.
| Study group | Role | What they receive |
|---|---|---|
| 25 mg adalimumab-680LT and 15/25 mg risankizumab-800CW | Experimental | Patients receive 25 mg adalimumab-680LT and 15/25 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging Procedure Receives: Drug: 25mg adalimumab-680LT and 15/25 mg risankizumab-800CW |
| 25 mg adalimumab-680LT | Experimental | Patients starting with adalimumab will receive 25 mg adalimumab-680LT and undergo a Fluorescence Molecular Imaging procedure Receives: Drug: Adalimumab-680LT 25mg |
| 15/25 mg risankizumab-800CW | Experimental | Patients starting with risankizumab receive 15/25 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure Receives: Drug: Risankizumab-800CW 15 mg/25 mg |
| No second procedure | No intervention | Patients starting with drugs other than adalimumab or risankizumab will not undergo a second procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the feasibility of using dual wavelengths fluorescence molecular endoscopy (FME)
Visual evaluation and distinction of both tracers during FME (visible signal yes/no), as well as TBR and CNR calculations, will be performed to assess in vivo signal detectability.
Measured: 12 months
To investigate the feasibility of using ex vivo fluorescence molecular imaging (FMI) to detect adalimumab-680LT and risankizumab-800CW signals
Ex vivo analysis will include mean fluorescence intensities (MFIs) of biopsies, MDSFR/SFF measurements, and fluorescence and light sheet microscopy to quantify and localize tracer signals.
Measured: 12 months
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
Secondary outcomes (4)
To investigate a potential correlation of in vivo and ex vivo fluorescence signal intensities and target saturation to clinical response/remission after 14 weeks of adalimumab/risankizumab therapy regimen in patients with IBD.
This will involve semi-quantitative and spectroscopic analysis of fluorescence signals during endoscopy and in biopsies, comparison with inflammation scores, and molecular validation of tracer binding and immune cell localization to assess predictive and response-related biomarkers.
Measured: 12 months
To quantify the fluorescence signals of the tracers in vivo by using single-fiber reflectance/single-fiber fluorescence (MDSFR/SFF) spectroscopy and correlate these measurements to inflammation severity.
This will be achieved through real-time spectroscopic quantification of fluorescence signals during endoscopy in each investigated bowel segment, followed by comparison with endoscopic and histologic inflammation scores to assess the relationship between tracer signal intensity and tissue inflammation.
Measured: 12 months
To evaluate the adalimumab-680LT and risankizumab-800CW distribution inside mucosal biopsies
This will be achieved through 3D ex vivo fluorescence signal analysis of intact biopsies collected from high and low fluorescence areas during endoscopy, enabling assessment of tracer distribution across inflamed and non-inflamed tissue. Additional validation will include SDS-PAGE to confirm tracer integrity, fluorescence microscopy, and immunofluorescence staining to visualize and quantify tracer-positive cells and their immune cell types.
Measured: 12 months
To identify the composition of immune cells in the mucosal microenvironment of IBD patients and gain new insights into the target cells and distribution of adalimumab and risankizumab
This will be addressed through fluorescence microscopy and immunofluorescence staining of FFPE biopsy slides to visualize adalimumab-680LT and risankizumab-800CW signals and identify immune cell types (e.g., CD68, CD3, CD8, CD20). The number and distribution of tracer-positive cells and immune subsets will be quantified to explore associations with therapy response and mucosal immune profiles.
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 posted2 Dec 2025
- Study start15 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Apr 2028 (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
- 30 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
- NCT07258641
- Sponsor's protocol ID
- UMCG 21773
- Other IDs
- 2025-521420-30-00, 2025
- Acronym
- VOYAGER
- Status last verified
- Apr 2025
- First submitted
- 20 Nov 2025
- Last updated
- 14 Jan 2026
- 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Wavelength Fluorescence Imaging Using Fluorescently Labelled Adalimumab and Risankizumab for Visualizing Drug Targeting in Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT07258641
- Acronym / sponsor ID
- VOYAGER / UMCG 21773
- Conditions
- Ulcerative Colitis (UC), Crohn Disease (CD)
- Keywords
- Fluorescence Molecular Endoscopy, Inflammatory Bowel Disease, Risankizumab-800CW, Adalimumab-680LT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 2 Dec 2025 (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.
Inflammatory bowel diseases (IBD) are chronic relapsing inflammatory disorders of the gastrointestinal tract affecting 2.5 million patients in Europe alone. The majority of newly diagnosed patients are in adolescence or early adulthood and in the midst of their family life, career, and social development.
IBD comes with significant morbidity and complex treatment strategies and is associated with a high social burden and medical costs. Besides other factors, the pathogenesis of IBD is attributed to proinflammatory cytokine tumor necrosis factor α (TNFα) and Interleukin 23 (IL-23). Adalimumab, a human monoclonal anti-TNF antibody, and risankizumab, a humanized monoclonal anti-IL-23 antibody, are used to treat patients with moderate to severely active IBD. However, IBD patients often only partially respond to such biological immunomodulating therapies, resulting in high primary nonresponse (30-60%) and loss of response over time (48-58%). The investigators are currently missing reliable tools for response prediction because the limitations of current technologies do not allow the visualization of the molecular phenotype or heterogeneity within patients. Therefore, patients are potentially exposed to a non-effective treatment and its potential side effects while clinical deterioration is ongoing. In addition, it remains completely unknown for most biologicals used for IBD therapy whether they reach their actual targets in the tissue and if a sufficient local concentration is present to achieve treatment response. To develop a predictive tool for assessment of therapeutic (non-)response to patients and gain insights into local drug concentrations in individual patients before initiating anti-TNF or anti-IL23 therapy, the University Medical Center Groningen (UMCG), fluorescently labeled adalimumab (adalimumab-680LT) and risankizumab (risankizumab-800CW) to visualize and quantify the labeled drugs in diseased tissue with dedicated optical fluorescence imaging systems. In previous studies, the investigators have proven that those tracers bind to TNFα/IL23 in the mucosa after intravenous injection and that the investigators can investigate the drug distribution in vivo due to the colocalization of the fluorescently labeled compound. The aim of this follow-up study is to assess the feasibility of simultaneous dual wavelength imaging of adalimumab-680LT and risankizumab-800CW at baseline and evaluate target saturation after at least 14 weeks of adalimumab or risankizumab therapy. The investigators will also use in vivo and ex vivo fluorescence molecular imaging (FMI) to visualize tracer target cells and the patient's molecular phenotype for potential treatment response prediction in IBD patients in the future.
The investigators will determine the feasibility of dual wavelengths molecular fluorescence imaging using the GMPproduced near-infrared fluorescent tracers adalimumab-680LT and risankizumab-800CW for visualizing medicine distribution in and ex vivo IBD patients with dedicated fluorescence imaging systems.
Furthermore, the investigators will evaluate TNF and IL23 target saturation after 14 weeks of adalimumab or risankizumab therapy and characterize the tissue microenvironment where the drug is abundant and identify potential drug target cells.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 25 mg adalimumab-680LT and 15/25 mg risankizumab-800CW | Experimental | Drug: 25mg adalimumab-680LT and 15/25 mg risankizumab-800CWPatients receive 25 mg adalimumab-680LT and 15/25 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging Procedure |
| 25 mg adalimumab-680LT | Experimental | Drug: Adalimumab-680LT 25mgPatients starting with adalimumab will receive 25 mg adalimumab-680LT and undergo a Fluorescence Molecular Imaging procedure |
| 15/25 mg risankizumab-800CW | Experimental | Drug: Risankizumab-800CW 15 mg/25 mgPatients starting with risankizumab receive 15/25 mg risankizumab-800CW and undergo a Fluorescence Molecular Imaging procedure |
| No second procedure | No intervention | –Patients starting with drugs other than adalimumab or risankizumab will not undergo a second procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Established IBD diagnosis (UC or CD).
- Active disease: clinically active disease of the bowel is defined 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 adalimumab or risankizumab therapy.
- Age of 18 years
- Written informed consent
Key exclusion criteria (6 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 adalimumab-680LT and/or risankizumab 800CW administration
- 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)
- Prior anti-TNFα therapy in the last 6 weeks before inclusion
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 |
|---|---|---|
| 25mg adalimumab-680LT and 15/25 mg risankizumab-800CWAdalimumab-680LT and 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 dual-wavelength fluorescence signals. | Drug | 25 mg adalimumab-680LT and 15/25 mg risankizumab-800CW |
| Adalimumab-680LT 25mgAdalimumab-680LT 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 adalimumab-680LT |
| Risankizumab-800CW 15 mg/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 | 15/25 mg risankizumab-800CW |
Primary outcome
To investigate the feasibility of using dual wavelengths fluorescence molecular endoscopy (FME)
Time frame: 12 months
Visual evaluation and distinction of both tracers during FME (visible signal yes/no), as well as TBR and CNR calculations, will be performed to assess in vivo signal detectability.
To investigate the feasibility of using ex vivo fluorescence molecular imaging (FMI) to detect adalimumab-680LT and risankizumab-800CW signals
Time frame: 12 months
Ex vivo analysis will include mean fluorescence intensities (MFIs) of biopsies, MDSFR/SFF measurements, and fluorescence and light sheet microscopy to quantify and localize tracer signals.
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
4 secondary outcomes
To investigate a potential correlation of in vivo and ex vivo fluorescence signal intensities and target saturation to clinical response/remission after 14 weeks of adalimumab/risankizumab therapy regimen in patients with IBD.
Time frame: 12 months
To quantify the fluorescence signals of the tracers in vivo by using single-fiber reflectance/single-fiber fluorescence (MDSFR/SFF) spectroscopy and correlate these measurements to inflammation severity.
Time frame: 12 months
To evaluate the adalimumab-680LT and risankizumab-800CW distribution inside mucosal biopsies
Time frame: 12 months
To identify the composition of immune cells in the mucosal microenvironment of IBD patients and gain new insights into the target cells and distribution of adalimumab and risankizumab
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 14 Jan 2026.
- 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 25mg adalimumab-680LT and 15/25 mg risankizumab-800CW, Adalimumab-680LT 25mg and Risankizumab-800CW 15 mg/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 9 inclusion and 6 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: opening soon, as of the sponsor's last update on 14 Jan 2026. 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, Professor (+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?
To investigate the feasibility of using dual wavelengths fluorescence molecular endoscopy (FME) (time frame: 12 months). The study lists 5 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 14 Jan 2026.