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New treatment option for Ulcerative Colitis (UC)
Official title Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
ClinicalTrials.gov ID: NCT06606808
What this study is testing
What is Risankizumab-800CW 4.5 mg?
Risankizumab-800CW 4.5 mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ulcerative colitis (uc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for part A:
- Established IBD diagnosis
- Active disease: clinically active disease of the bowel is defined clinically as at least mild activity using dedicated scoring indices or...
- Patients must be eligible for risankizumab therapy
- Minimum age of 18 years
You likely can't join if
- for part A:
- 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...
- 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) Exclusion Criteria for part...
See the full eligibility criteria
- for part A:
- 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 for part B:
- 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
- for part A:
- 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) Exclusion Criteria for part B:
- 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
- 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.
Where it's taking place
- Groningen, Netherlands
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.