CClinicalTrials.gg
RecruitingNCT05725876VIDEOUpdated Jan 15, 2025

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

A Phase 1 interventional study of Ustekinumab in Psoriasis and Crohn Disease, sponsored by University Medical Center Groningen. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-15.

Sponsored by University Medical Center Groningen · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis
  • Crohn Disease
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 56 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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);
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    Patients with Crohn's disease eligible for ustekinumab therapy

    Drug: Ustekinumab

  • Experimental
    Patients with Psoriasis eligible for Ustekunimab treatment

    Drug: Ustekinumab

Interventions

  • DrugUstekinumab

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

06

What researchers measure

Primary outcomes

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

    Time frame: 3-4 days after tracer admission

07

Study locations

1 of 1 sites recruiting
  • University Medical Center Groningen
    Groningen, 9713GZ, Netherlands
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05725876
Lead sponsor
University Medical Center Groningen
Responsible party
Sponsor
First posted
Feb 13, 2023
Start date
Jan 6, 2025
Primary completion
Jul 1, 2026 (estimated)
Completion
Jan 6, 2027 (estimated)
Last update
Jan 15, 2025

Study contacts

W.B. Nagengast, MD, PhD, PharmD
Contact
w.b.nagengast@umcg.nl
+31503612620
A.J. Sterkenburg, MSc
Contact
a.j.sterkenburg@umcg.nl
+316 55257029

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion