Quantitative Fluorescence molecular imaging in Crohn’s disease and psoriasis

Phase 1

Not yet recruiting

• Conditions: Crohn's disease; Psoriasis
• Interventions: Drug: Ustekinumab

• Registration Number: 2023-506192-10-00
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-24
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Patients with Crohn's disease eligible for ustekinumab therapy	Ustekinumab	-
Patients with Psoriasis eligible for Ustekunimab treatment	Ustekinumab	-

Primary Outcome Measures

Name	Time	Method
Quantification of fluorescent signal of fluorescent ustekinumab in CD and psoriasis patients.	3-4 days after tracer admission

Trial Locations

Locations (1)

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Universitair Medisch Centrum Groningen

🇳🇱Groningen, Netherlands

Wouter Nagengast

Site contact

+31503612620

w.b.nagengast@umcg.nl