Adalimumab for Inflammatory bowel disease (IBD)|Ulcerative colitis|Crohn's disease

Inclusion criteria

• {"criterion_text":"- Established IBD diagnosis (UC or CD)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients must be eligible for adalimumab or risankizumab therapy"}
• {"criterion_text":"- Age of at least 18 years"}
• {"criterion_text":"- Written informed consent"}
• {"criterion_text":"- Clinical indication for an endoscopic procedure"}
• {"criterion_text":"- 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

• {"criterion_text":"- A female study patient who is pregnant or provides breastfeeding"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Medical or psychiatric conditions that compromise the patient’s ability to give informed consent"}
• {"criterion_text":"- Prior anti-IL23-specific therapy (IL12/IL23 combination therapy is not an exclusion criteria)"}
• {"criterion_text":"- Prior anti-TNFα therapy in the last 6 weeks before inclusion"}
• {"criterion_text":"- Previous treatment with adalimumab and detectable anti-adalimumab antibody levels"}

Primary endpoints

• {"endpoint_text":"- Visual evaluation and distinction of both tracers during FME (visible signal yes/no), TBR and CNR calculations, mean fluorescence intensities (MFIs) of biopsies, MDSFR/SFF measurements and fluorescence/ light sheet microscopy","definition_or_measurement_approach":"Measured by visual evaluation during FME (visible signal yes/no), calculation of target-to-background ratio (TBR) and contrast-to-noise ratio (CNR), mean fluorescence intensities (MFIs) of biopsies, MDSFR/SFF spectroscopy measurements and fluorescence/light sheet microscopy."}

Secondary endpoints

• {"endpoint_text":"- Analysis of in vivo fluorescence images and quantification of fluorescence signal in real-time by spectroscopy. Semi-quantification of the fluorescence within mucosal biopsies (FFPE) with fluorescence scans and comparison with endoscopic/histologic inflammation score and in vivo results. Look at possible correlation of in vivo and ex vivo measured and quantified fluorescence and endoscopic/histologic response to adalimumab/risankizumab therapy","definition_or_measurement_approach":"Real-time spectroscopy quantification of in vivo fluorescence images; semi-quantification of fluorescence in FFPE mucosal biopsies with fluorescence scans; comparison/correlation with endoscopic and histologic inflammation scores and clinical response to therapy."}
• {"endpoint_text":"- Quantification of fluorescent signals by dual wavelengths spectroscopy during the endoscopy. Measurements will be correlated with fluorescence intensities visualized using the FME camera and endoscopic/histologic inflammation severity to draw any conclusions about adalimumab/risankizumab distribution into inflamed or non-inflamed tissue. We hypothesize a positive correlation between the fluorescence signal and the tracer dose and between the fluorescence signal and the inflammation scores","definition_or_measurement_approach":"Dual-wavelength spectroscopy measurements during endoscopy correlated with FME camera visualization and endoscopic/histologic inflammation severity; analyze correlations with tracer dose and inflammation scores."}
• {"endpoint_text":"- 3D ex vivo fluorescence signal analysis on intact biopsies taken in high and low fluorescence areas during the endoscopy to assess the distribution of labeled adalimumab-680LT/risankizumab-800CW. We use SDS-PAGE with protein extract of the biopsies obtained during the endoscopy procedures and the patients' blood samples to prove tracer integrity. We will detect the protein and mRNA expression of TNF and IL23 via Western Blot to determine a correlation between tracer signal and target expression","definition_or_measurement_approach":"3D ex vivo fluorescence analysis of intact biopsies from high/low fluorescence areas; SDS-PAGE of biopsy and blood extracts to assess tracer integrity; Western Blot and mRNA detection for TNF and IL23 to correlate tracer signal with target expression."}
• {"endpoint_text":"- We will perform fluorescence microcopy on FFPE slides of the biopsies to microscopically visualize the adalimumab-680LT/risankizumab-800CW signal and perform additional immunofluorescence staining (CD68, CD3, CD8, CD20, etc.) for different immune cell types to identify the immune cell type of adalimumab-680LT/risankizumab-800CW positive cells","definition_or_measurement_approach":"Fluorescence microscopy on FFPE biopsy slides to visualize tracer signal and immunofluorescence staining for immune cell markers (CD68, CD3, CD8, CD20, etc.) to identify tracer-positive cell types."}

Netherlands

Earliest CTIS Part Ii Submission Date

16-12-2025

Latest Decision Or Authorization Date

06-01-2026

Processing Time Days

21

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands