Actively Recruiting
Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis.
Led by University Medical Center Groningen · Updated on 2025-01-15
56
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of Crohn's Disease or psoriasis
- Non-responsive to conventional therapy
- Active disease: for Crohn's Disease, moderate clinical or biochemical activity; for psoriasis, PASI score of 10 or higher or dermatologist-assessed active disease
- Age 18 years or older
- Provided written informed consent
You will not qualify if you...
- Medical or psychiatric conditions affecting ability to give informed consent
- Prior ustekinumab treatment within 15 weeks (except for study treatment and control groups)
- Ustekinumab is contraindicated for therapy
- Pregnancy or breastfeeding; negative pregnancy test required for women of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands, 9713GZ
Actively Recruiting
Research Team
W
W.B. Nagengast, MD, PhD, PharmD
CONTACT
A
A.J. Sterkenburg, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
2
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