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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis; Crohn Disease
• Intervention / Treatment: Drug: Ustekinumab

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: A.J. Sterkenburg, MSc; Phone Number: +316 55257029; Email: a.j.sterkenburg@umcg.nl
• Study Contact Backup: Name: W.B. Nagengast, MD, PhD, PharmD; Phone Number: +31503612620; Email: w.b.nagengast@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: Andrea Sterkenburg; Phone Number: +31 50 361 26 20; Email: a.j.sterkenburg@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Crohn's disease eligible for ustekinumab therapy	Drug: Ustekinumab; Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.
Experimental: Patients with Psoriasis eligible for Ustekunimab treatment	Drug: Ustekinumab; Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 6, 2027

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Psoriasis; Crohn Disease; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: 83371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No