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Recruiting NCT07746583

A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical Practice

— Observational Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

The main purpose of this study is to describe how well Guselkumab works after switching from Ustekinumab in participants with moderate to severe psoriasis in a routine clinical setting. A long-term skin disease that causes red, scaly and sometimes painful, itchy patches on the skin.

Primary outcome measures

  • Percentage of Participants Achieving Absolute Psoriasis Area Severity Index (aPASI) <=3 at Week 20 Following Switch from Ustekinumab to Guselkumab [Time frame: At Week 20]
Secondary outcome measures (12)
  • Percentage of Participants Achieving aPASI <= 3 at Weeks 4, 12, 36 and 52 [Time frame: At Weeks 4, 12, 36 and 52]
  • Percentage of Participants Achieving >= 75% Improvement in PASI (PASI 75) at Weeks 4, 12, 20, 36 and 52 [Time frame: At Weeks 4, 12, 20, 36 and 52]
  • Percentage of Participants Achieving >= 90% Improvement in PASI (PASI 90) at Weeks 4, 12, 20, 36, and 52 [Time frame: At Weeks 4, 12, 20, 36 and 52]
  • Percentage of Participants Achieving 100% Improvement in PASI (PASI 100) at Weeks 4, 12, 20, 36, and 52 [Time frame: At Weeks 4, 12, 20, 36 and 52]
  • Absolute Changes in PASI Score from Baseline up to Weeks 4, 12, 20, 36 and 52 [Time frame: Baseline up to Weeks 4, 12, 20, 36 and 52]
  • Absolute Changes in Body Surface Area (BSA) Score from Baseline up to Weeks 4, 12, 20, 36 and 52 [Time frame: Baseline up to Weeks 4, 12, 20, 36 and 52]
  • Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) <=5 at Weeks 4, 12, 20, 36 and 52 [Time frame: At Weeks 4, 12, 20, 36 and 52]
  • Percentage of Participants Achieving Dermatology Life Quality Index Relevant (DLQI-R) <=5 at Weeks 4, 12, 20, 36 and 52 [Time frame: At Weeks 4, 12, 20, 36 and 52]
  • Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52 [Time frame: At Weeks 4, 12, 20, 36 and 52]
  • Percentage of Participants Achieving DLQI-R score of 0 or 1 at Weeks 4, 12, 20, 36 and 52 [Time frame: At Weeks 4, 12, 20, 36 and 52]
  • Absolute Changes in DLQI Scores from Baseline up to Weeks 4, 12, 20, 36 and 52 [Time frame: Baseline up to Weeks 4, 12, 20, 36 and 52]
  • Absolute Changes in DLQI-R Scores from Baseline up to Weeks 4, 12, 20, 36 and 52 [Time frame: Baseline up to Weeks 4, 12, 20, 36 and 52]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Hungary · 1 center
  • Semmelweis University — Budapest

Identifiers

NCT: NCT07746583 · CNTO1959PSO4038 · CNTO1959PSO4038

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗