Investigating how ustekinumab distributes in inflamed tissues for Crohn's disease and psoriasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Guselkumab after Ustekinumab in adults with moderate-to-severe psoriasis in routine care

  This study looks at how well guselkumab works for people with moderate-to-severe psoriasis after switching from ustekinumab in everyday clinical practice.

  Recruiting Janssen-Cilag Kft. · Budapest · NCT07746583

• Guselkumab in Breast Milk for Lactating Women on Guselkumab

  This study tests how much guselkumab is present in the breast milk of lactating women who are already receiving guselkumab for their approved conditions.

  Recruiting Phase 4 Janssen Research & Development, LLC · Chapel Hill, North Carolina · NCT07654751

• Guselkumab for Chinese patients with Crohn's disease who stopped responding to ustekinumab

  This study tests whether guselkumab can help Chinese patients with active Crohn's disease who initially responded to ustekinumab but later lost response.

  Recruiting at 5 sites Phase 4 Xian-Janssen Pharmaceutical Ltd. · Guangzhou and 4 other locations · NCT07310095

• Observational study on patients switching to a biosimilar treatment for Crohn's disease and plaque psoriasis

  This study is testing if switching to a new biosimilar treatment for Crohn's disease and plaque psoriasis helps patients stay in remission and feel satisfied with their care.

  Recruiting Celltrion HealthCare France · Amiens · NCT06997055

• Comparing dual-target therapy with intensified Ustekinumab for Crohn's disease

  This study is testing if a new combination treatment of Ustekinumab and Upadacitinib can help people with Crohn's disease feel better compared to a higher dose of Ustekinumab alone.

  Recruiting Phase 4 Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT06520397

• Evaluating Ustekinumab for Treating Stricturing Crohn's Disease

  This study is testing if ustekinumab can help people with moderate-to-severe Crohn's disease who have blockages in their intestines feel better over a two-year period.

  Recruiting at 8 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Beijing, Beijing Municipality and 7 other locations · NCT05387031

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.