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NCT Number: NCT05725876

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location status: Recruiting

Location contact

Andrea Sterkenburg

CONTACT

[email protected]

+31 50 361 26 20

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Ustekinumab

Drug

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

Primary outcomes

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

    Time frame: 3-4 days after tracer admission

Study contacts

Contact information is provided by the study sponsor or research team.

A.J. Sterkenburg, MSc

CONTACT

[email protected]

+316 55257029

W.B. Nagengast, MD, PhD, PharmD

CONTACT

[email protected]

+31503612620

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: VIDEO

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 13, 2023
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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