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New treatment option for Psoriasis
Official title Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis.
ClinicalTrials.gov ID: NCT05725876
What this study is testing
What is Ustekinumab?
Ustekinumab is an investigational medicine, being studied as a potential treatment for psoriasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Crohn's Disease (CD) and psoriasis are chronic inflammatory diseases. Ustekinumab is a humanized monoclonal antibody.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- PsO: clinically active disease of at least PASI ≥ 10 or clinically active disease as assessed by a dermatologist;
You likely can't join 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...
See the full eligibility 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...
- PsO: clinically active disease of at least PASI ≥ 10 or clinically active disease as assessed by a dermatologist;
- Age ≥ 18 years;
- Written informed consent.
- 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);
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.