RecruitingPhase 1NCT05725876

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

Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis: a Prospective Pilot Intervention Study


Sponsor

University Medical Center Groningen

Enrollment

56 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special fluorescent imaging technique to track how ustekinumab — a drug used to treat Crohn's disease and psoriasis — actually distributes into inflamed tissue. The goal is to understand whether the drug is reaching the right areas of the body. **You may be eligible if...** - You have a confirmed diagnosis of Crohn's disease or psoriasis - Your condition is active (moderate to severe symptoms) and has not responded to standard treatments - You are starting ustekinumab as part of your regular care **You may NOT be eligible if...** - Your disease is in remission or well-controlled - You have contraindications to ustekinumab - You are unable to undergo the imaging procedures required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUstekinumab

Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.


Locations(1)

University Medical Center Groningen

Groningen, Netherlands

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NCT05725876


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