Crohn'sRecruiting

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

Phase 1 · Testing Ustekinumab · 1 site · University Medical Center Groningen

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Ustekinumab (a drug). Condition(s) listed: Psoriasis and Crohn Disease.

It is open-label: participants know what they are receiving.

Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.

Who can join

Ages 18 and older
Any sex

Some of the main requirements, copied from the record:

Established diagnosis of CD or PsO
Non-responsive to conventional therapy
Active disease:

Plus 4 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 56 participants are expected to take part.
Start date: 2025-01-06.
Main results expected around 2026-07-01 (estimate from the record).
1 study site listed (1 marked recruiting) in Netherlands.

Main thing being measured

Quantification of fluorescent signal of fluorescent ustekinumab in CD and psoriasis patients. (3-4 days after tracer admission)

In the researchers’ words

Crohn's Disease (CD) and psoriasis are chronic inflammatory diseases. Ustekinumab is a humanized monoclonal antibody.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Phase 1
Study type	Interventional
Conditions	Psoriasis; Crohn Disease
Lead sponsor	University Medical Center Groningen
Enrollment	56 (estimated)
Start date	2025-01-06
Primary completion (est.)	2026-07-01
First posted	2023-02-13
Last updated	2025-01-15
Official 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
ClinicalTrials.gov ID	NCT05725876

Interventions

Ustekinumab (Drug)
Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.

Full eligibility criteria (from the record)

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);

Locations (1)

Site	City	Country	Site status
University Medical Center Groningen	Groningen	Netherlands	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.