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

NCT05725876 | Recruiting Phase 1

• 1 other identifier: 83371
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Quantification of fluorescent signal of fluorescent ustekinumab in CD and psoriasis patients.

  3-4 days after tracer admission

Study Arms (2)

Patients with Crohn's disease eligible for ustekinumab therapy

EXPERIMENTAL

Drug: Ustekinumab

Patients with Psoriasis eligible for Ustekunimab treatment

EXPERIMENTAL

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

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

Patients with Crohn's disease eligible for ustekinumab therapy; Patients with Psoriasis eligible for Ustekunimab treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Psoriasis; Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

W.B. Nagengast, MD, PhD, PharmD

CONTACT

+31503612620; w.b.nagengast@umcg.nl

A.J. Sterkenburg, MSc

CONTACT

+316 55257029; a.j.sterkenburg@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 15 naive patients before treatment and 10 patients on treatment in both diseases. Next to this we will also include 3 control patients in each disease. So 28 procedures for each disease.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: January 6, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 6, 2027
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)