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

Sponsor
University Medical Center Groningen
Study ID
NCT05725876
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.

Study Details

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.

Key Dates

Start date
Jan 6, 2025
Status verified
Jan 2025
Primary completion
Jul 1, 2026
Completion
Jan 6, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Patients with Crohn's disease eligible for ustekinumab therapy
  • Experimental: Patients with Psoriasis eligible for Ustekunimab treatment

Primary Outcome Measure

Quantification of fluorescent signal of fluorescent ustekinumab in CD and psoriasis patients. [ Time Frame: 3-4 days after tracer admission ]

Central Contacts

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