A Phase 1 interventional study of Ustekinumab in Psoriasis and Crohn Disease, sponsored by University Medical Center Groningen. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by University Medical Center Groningen · Phase 1, Interventional, and Other
Crohn's Disease (CD) and psoriasis are chronic inflammatory diseases. Ustekinumab is a humanized monoclonal antibody. Ustekinumab is expensive and primary non-response is high in both CD and psoriasis. Currently, there are no predictors of response to ustekinumab and the actual mechanism of action has not yet been elucidated. To clarify the mechanism of action and gain a better understanding of the high primary non-response rates, the University Medical Center Groningen (UMCG) developed a tracer fluorescently labeling ustekinumab. This study aims to gain insight into ustekinumab distribution and concentrations in the gut. The current study aims to identify the ustekinumab target cells in the inflamed gut mucosa and skin using quantitative fluorescence molecular endoscopy (qFME). By gaining insight into local ustekinumab concentrations, drug distribution, and by discovering target cells, we expect to gain insight into the mechanism of action of ustekinumab.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 56 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Active disease:
Exclusion Criteria:
Drug: Ustekinumab
Drug: Ustekinumab
Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.
Quantification of fluorescent signal of fluorescent ustekinumab in CD and psoriasis patients.
Time frame: 3-4 days after tracer admission
Plan to share: No
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University Medical Center Groningen