Fluorescence Imaging of Adalimumab-680LT and Risankizumab-800CW in Inflammatory Bowel Disease
Phase 1 / Phase 2 · Testing 25mg adalimumab-680LT and 15/25 mg risankizumab-800CW, Adalimumab-680LT 25mg and… · 1 site · University Medical Center Groningen
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing 25mg adalimumab-680LT and 15/25 mg risankizumab-800CW (a drug), Adalimumab-680LT 25mg (a drug) and Risankizumab-800CW 15 mg/25 mg (a drug). Condition(s) listed: Ulcerative Colitis (UC) and Crohn Disease (CD).
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 6 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- Start date: 2026-01-15 (planned).
- Main results expected around 2027-12-31 (estimate from the record).
- 1 study site listed in Netherlands.
Main thing being measured
- To investigate the feasibility of using dual wavelengths fluorescence molecular endoscopy (FME) (12 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC); Crohn Disease (CD) |
| Lead sponsor | University Medical Center Groningen |
| Enrollment | 30 (estimated) |
| Start date | 2026-01-15 |
| Primary completion (est.) | 2027-12-31 |
| First posted | 2025-12-02 |
| Last updated | 2026-01-14 |
| Official title | Dual Wavelength Fluorescence Imaging Using Fluorescently Labelled Adalimumab and Risankizumab for Visualizing Drug Targeting in Inflammatory Bowel Diseases |
| ClinicalTrials.gov ID | NCT07258641 |
Interventions
- 25mg adalimumab-680LT and 15/25 mg risankizumab-800CW (Drug)
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 25mg (Drug)
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 mg (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.
Full eligibility criteria (from the record)
Inclusion Criteria: 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 * 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. 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 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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Groningen | Groningen, Provincie Groningen | Netherlands |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.