Investigating how ustekinumab distributes in inflamed tissues for Crohn's disease and psoriasis
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
This study is testing how well the drug ustekinumab works in people with Crohn's disease and psoriasis who haven't found relief from other treatments by looking at where the drug goes in their inflamed tissues.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | ustekinumab |
| Locations | 1 site (Groningen) |
| Trial ID | NCT05725876 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the distribution and concentration of ustekinumab, a monoclonal antibody, in patients with Crohn's disease and psoriasis who have not responded to conventional therapies. By using quantitative fluorescence molecular endoscopy (qFME), researchers will identify the target cells for ustekinumab in inflamed gut and skin tissues. The goal is to gain insights into the drug's mechanism of action and address the high rates of primary non-response. Participants will be closely monitored to assess the drug's effectiveness in their specific conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with an established diagnosis of Crohn's disease or psoriasis who are non-responsive to conventional therapies and have active disease.
Not a fit: Patients who have previously received ustekinumab treatment within the last 15 weeks or those for whom ustekinumab is contraindicated may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of ustekinumab's effectiveness, potentially enhancing treatment strategies for patients with Crohn's disease and psoriasis.
How similar studies have performed: While this approach is innovative, there is limited information on similar studies, indicating that this may be a novel exploration in understanding ustekinumab's action.
Eligibility criteria
Show full inclusion / exclusion 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);
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: W.B. Nagengast, MD, PhD, PharmD
- Email: w.b.nagengast@umcg.nl
- Phone: +31503612620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.