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Dual wavelength fluorescence imaging using fluorescently labelled adalimumab and risankizumab for visualizing drug targeting in Inflammatory Bowel Diseases (VOYAGER)
EU CTIS ID: 2025-521420-30-00
What this study is testing
To investigate the feasibility of the Windu system to use dual tracer fluorescence molecular endoscopy (FME) and ex vivo FMI to detect adalimumab-680LT and risankizumab-800CW signals.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 at least 18 years
- Written informed consent
- Clinical indication for an endoscopic procedure
You likely can't join if
- 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 (IL12/IL23 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
See the full eligibility 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 at least 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.
- 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 (IL12/IL23 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.