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

NCT ID: NCT05725876

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2027-01-06

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.

Conditions

Psoriasis; Crohn Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with Crohn's disease eligible for ustekinumab therapy

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.

Patients with Psoriasis eligible for Ustekunimab treatment

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.

Interventions

Ustekinumab

Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.

Intervention Type: DRUG

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, 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;
• 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;
• Prior ustekinumab treatment within the last 15 weeks (except for patients in the treatment arm and control group);
• 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);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

W.B. Nagengast, MD, PhD, PharmD

Role: CONTACT

w.b.nagengast@umcg.nl

+31503612620

A.J. Sterkenburg, MSc

Role: CONTACT

a.j.sterkenburg@umcg.nl

+316 55257029

Facility Contacts

Andrea Sterkenburg

Role: primary

a.j.sterkenburg@umcg.nl

+31 50 361 26 20

Other Identifiers

83371

Identifier Type: -

Identifier Source: org_study_id