NCT05725876 Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis.
| NCT ID | NCT05725876 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University Medical Center Groningen |
| Condition | Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 56 participants in total. It began in 2025-01-06 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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);
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05725876 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05725876 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05725876 currently recruiting?
Yes, NCT05725876 is actively recruiting participants. Contact the research team at w.b.nagengast@umcg.nl for enrollment information.
Where is the NCT05725876 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT05725876 clinical trial?
NCT05725876 is sponsored by University Medical Center Groningen. The trial plans to enroll 56 participants.
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