RecruitingNCT07449234

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

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


Sponsor

Janssen-Cilag Ltd.

Enrollment

200 participants

Start Date

Feb 9, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to assess the effectiveness and safety of guselkumab following a switch from ustekinumab or an ustekinumab biosimilar in participants with moderate to severe psoriasis, a chronic inflammatory skin disease characterized by erythematous, scaly plaques that may be associated with pain and pruritus, in routine clinical practice.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Must have a confirmed diagnosis of moderate-to-severe plaque psoriasis requiring systemic treatment
  • Participants who are currently treated with Ustekinumab (either the originator or its biosimilar) and who are medically indicated to switch to Guselkumab
  • Participants who, based on the Investigator's decision, should initiate treatment with Guselkumab
  • Participants must understand and be willing and able to answer patient-reported outcomes (PROs)
  • Must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria4

  • Contraindication or hypersensitivity to Guselkumab or any ingredient in the injection solution/liquid
  • Pregnancy or breastfeeding
  • Currently enrolled in an interventional study
  • Currently enrolled in an observational study sponsored or managed by a Janssen company

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Locations(1)

LKH-Univ. Klinikum Graz

Graz, Austria

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NCT07449234


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