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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Psoriasis, Crohn Disease

Intervention / Treatment
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* Drug: Ustekinumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established diagnosis of CD or PsO 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, see below) or biochemically active disease as defined by a faecal calprotectin > 200 ug/g; PsO: clinically active disease of at least PASI ≥ 10 or clinically active disease as assessed by a dermatologist; Ustekinumab naïve and eligible for ustekinumab treatment (except for patients in the treatment arm); Age ≥ 18 years; Written informed consent. Exclusion Criteria: Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician; Concurrent uncontrolled medical conditions according to treating medical physician; Prior ustekinumab treatment (except for patients in the treatment arm); Ustekinumab contraindicated as therapy; Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause); Received a different investigational drug within 30 days prior to the dose of ustekinumab-800CW according to the patient's medical history; History of infusion reactions to ustekinumab or other monoclonal antibodies according to the patient's medical history; Received any live (including attenuated) vaccination within the 8 weeks prior to the inclusion. Live vaccines are not allowed during the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 15 naive patients before treatment and 10 control patients during treatment in both diseases. So 2 arms in each disease.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ustekinumab naïve patients<br> | Drug: Ustekinumab<br>* Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.<br>|
| Experimental: Ustekinumab treatment 12+ weeks<br> | Drug: Ustekinumab<br>* Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of fluorescent signal of fluorescent ustekinumab in CD and psoriasis patients. |  | 3-4 days after tracer admission |