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Study identifier: NCT05725876 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis.

Condition: Psoriasis · Crohn Disease  ·  Sponsor: University Medical Center Groningen

PhasePhase 1
Planned participants56
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

W.B. Nagengast, MD, PhD, PharmD  ·  +31503612620  ·  w.b.nagengast@umcg.nl

A.J. Sterkenburg, MSc  ·  +316 55257029  ·  a.j.sterkenburg@umcg.nl

Always discuss trial participation with your own doctor first.

Locations (1)

University Medical Center GroningenGroningen, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT05725876