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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Janssen-Cilag Kft. Industry-sponsored |
| Drugs / interventions | Ustekinumab, Guselkumab |
| Locations | 1 site (Budapest) |
| Status | Recruiting |
| Started | September 3, 2026 |
| Main results expected | January 30, 2029 |
| Study ends | March 15, 2029 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07746583 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
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Semmelweis University
Budapest, Hungary Recruiting
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Persistence on Guselkumab in Romanian adults with moderate-to-severe plaque psoriasis
This study looks at how many adults with moderate-to-severe plaque psoriasis continue guselkumab treatment over two years in Romania.
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Higher-dose, less-frequent guselkumab versus the usual dose for moderate-to-severe plaque psoriasis in Chinese adults
This will test whether a higher dose given less often of guselkumab works as well and is as safe as the usual dosing for Chinese adults with moderate-to-severe plaque psoriasis.
-
Guselkumab for adults with Crohn's disease after ustekinumab failure
This study will try guselkumab for adults with moderate to severe Crohn's disease who did not respond to or could not tolerate ustekinumab to see if they reach remission after 52 weeks.
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Guselkumab vs Ustekinumab for stricturing Crohn's disease
This study will follow adults with moderate-to-severe Crohn's disease and confirmed intestinal strictures to see if treatment with guselkumab or ustekinumab better controls obstructive symptoms and disease activity.
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Adjusting guselkumab dosing schedules for adults with plaque psoriasis
This project will see if adults with plaque psoriasis who are doing well on guselkumab can safely have their injections spaced farther apart than nine weeks.
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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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.