Clinical trial Recruiting at 1 site Observational Ages 18 and up

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

Official title: A Non-Interventional, Multi-Centric, Single Country Observational Study to Assess the Safety and Effectiveness of Guselkumab After Ustekinumab (Originator or Biosimilar) in Moderate to Severe Psoriasis Patients in Clinical Routine

Run by Janssen-Cilag Kft. · NCT07746583 · Data updated 2026-11-12

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

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorJanssen-Cilag Kft.
Industry-sponsored
Drugs / interventionsUstekinumab, Guselkumab
Locations1 site (Budapest)
StatusRecruiting
StartedSeptember 3, 2026
Main results expectedJanuary 30, 2029
Study endsMarch 15, 2029
Registry record updatedNovember 3, 2026
Trial IDNCT07746583 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with moderate-to-severe plaque psoriasis requiring systemic treatment who are switching from ustekinumab to guselkumab per local guidelines.

Probably not a fit

Those who do not respond to guselkumab or who discontinue treatment for non-safety reasons may not experience benefit.

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

What this trial studies

This observational study describes outcomes of patients with moderate-to-severe plaque psoriasis who switch from ustekinumab to guselkumab in routine clinical care. It includes adults meeting systemic-treatment criteria and who have a medical indication to switch per national psoriasis guidelines. Data collected will reflect real-world use, safety, and effectiveness of guselkumab following prior ustekinumab therapy. No interventional procedures are mandated; results come from standard clinical practice and patient records. Additional details on interventions and endpoints are not specified in the provided materials.

Why it matters

Potential benefit: If successful, switching to guselkumab may provide better skin control and patient quality of life for those who need a change in therapy.

How similar studies have gone: Other real-world observations have shown variable outcomes with biologic switches, indicating potential benefit but also the need for careful interpretation in routine practice.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria:

* Must have a confirmed diagnosis of moderate-to-severe plaque psoriasis requiring systemic treatment
* Participants who are currently being treated with Ustekinumab (either the originator or its biosimilar) and who are medically indicated to switch to Guselkumab, or for whom this switch is medically indicated, based on the current and valid national psoriasis (PsO) therapeutic protocol
* Participants who, based on the Investigator's decision, should initiate treatment with Guselkumab
* Participants must sign an informed consent form (ICF) allowing for data collection and source data verification in accordance with local requirements

Exclusion criteria:

* Contraindication or hypersensitivity to Guselkumab or any other ingredient in the injection solution
* Pregnancy or breastfeeding
* Currently enrolled in an interventional study
* Currently enrolled in an observational study sponsored or managed by a Janssen company
* Previous use of guselkumab in any indication in participant history

Where it's running

  • Semmelweis University
    Budapest, Hungary
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.