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

Recruiting Phase 1 Interventional Study
Psoriasis Crohn Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
56 (estimated)
Sponsor
University Medical Center Groningen · Other
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About This Trial
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 th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Established diagnosis of CD or PsO * Non-responsive to conventional therapy * Active disease: * CD cohort: clinically active disease of the bowel defined either clinically as at least moderate activity using dedicated scoring indices (for definitions of disease activity, se…
Contacts

W.B. Nagengast, MD, PhD, PharmD

+31503612620

w.b.nagengast@umcg.nl

CONTACT

A.J. Sterkenburg, MSc

+316 55257029

a.j.sterkenburg@umcg.nl

CONTACT