Actively Recruiting
Quantitative Fluorescence Imaging of Ustekinumab to Understand Drug Distribution in Inflamed Tissue in Crohn's Disease and Psoriasis: A Prospective Pilot Intervention Study
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 and psoriasis are chronic inflammatory conditions. This Phase 1 study is investigating the distribution and concentrations of ustekinumab, a humanized monoclonal antibody used in treating these diseases. Since ustekinumab is costly and many patients do not respond initially, researchers developed a fluorescent tracer to better understand how the drug works and why some patients do not respond. The study aims to identify the target cells of ustekinumab in inflamed gut mucosa and skin using quantitative fluorescence molecular endoscopy (qFME).
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
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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
A
A.J. Sterkenburg, MSc
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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