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Investigating the safety, feasibility, and optimal dose of risankizumab-800CW in IBD - NAVIGATE study
EU CTIS ID: 2024-515358-25-00
What this study is testing
To evaluate the safety of risankizumab-800CW through monitoring vital signs, the injection site and evaluating possible tracer-related (severe) adverse events (SAE/AEs) and suspected unexpected serious adverse events (SUSARs). To investigate the feasibility of using fluorescence molecular endoscopy (FME) and ex vivo FMI to detect risankizumab-800CW signals and to determine their most optimal imaging dose.
- Phase I and Phase II (Integrated)- First administration to humans
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 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.
- Age of 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 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)
See the full eligibility criteria
- Established IBD diagnosis (UC or CD).
- 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.
- Age of 18 years.
- Written informed consent.
- Clinical indication for an endoscopic procedure.
- For female subject 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 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)
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.