Inflammatory Bowel Disease
Conditions
Interventions
Study part A: Two to four days prior to the FME procedure, the included IBD patient will receive an intravenous injection of the fluorescent tracers adalimumab-680LT (25 mg) and risankizumab-800CW (15
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion 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/gPatients must be eligible for adalimumab or risankizumab therapy.Age of at least 18 yearsWritten informed consentClinical indication for an endoscopic procedureFor 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
Exclusion criteria: A female study patient who is pregnant or provides breastfeedingA 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 administrationMedical or psychiatric conditions that compromise the patient’s ability to give informed consentPrior anti-IL23-specific therapy (IL23/IL12 combination therapy is not an exclusion criteria)Prior anti-TNFa therapy in the last 6 weeks before inclusionPrevious treatment with adalimumab and detectable anti-adalimumab antibody levels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate a potential correlation of in vivo and ex vivo fluorescence signal intensities and target saturation to clinical response/remission after 14 weeks of adalimumab or risankizumab therapy in patients with IBDTo quantify the fluorescence signals of the tracers in vivo by using single-fiber reflectance/single-fiber fluorescence (MDSFR/SFF) spectroscopy and correlate these measurements to inflammation severityTo evaluate the adalimumab-680LT and risankizumab-800CW distribution inside mucosal biopsiesTo identify the composition of immune cells in the mucosal microenvironment of IBD patients and gain new insights into the distribution of adalimumab and risankizumab | — |
Countries
Netherlands
Contacts
Public ContactW.B. Nagengast
Universitair Medisch Centrum Groningen
Outcome results
None listed