Actively Recruiting
A Non-interventional, Multi-center Observational Study to Assess Safety and Effectiveness of Guselkumab After Switching From Ustekinumab in Moderate to Severe Psoriasis
Led by Janssen-Cilag Ltd. · Updated on 2026-05-08
200
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of guselkumab for people with moderate to severe psoriasis, a chronic skin condition causing red, scaly patches that can be painful and itchy. This study focuses on participants who are switching from ustekinumab or its biosimilar to guselkumab in routine clinical settings. The study is observational and aims to collect real-world data without changing standard care. Participants eligible for this study are those with moderate-to-severe psoriasis who are candidates for systemic treatment according to the guselkumab label and whose doctors have decided to switch their treatment from ustekinumab or its biosimilar to guselkumab. The study collects data based on routine clinical practice without administering any experimental treatments or interventions. During the study, researchers will observe participants over time, collecting information on skin condition severity using the Psoriasis Area and Severity Index (PASI) and other measures like body surface area affected, quality of life, itch severity, and work productivity. These assessments occur at several time points up to 52 weeks after switching treatments. The main outcome is the percentage of participants achieving a PASI score of 3 or less at week 28. Safety and various health impacts will also be tracked through patient questionnaires and clinical data.
CONDITIONS
Brief Title
A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of moderate-to-severe plaque psoriasis requiring systemic treatment
- Currently treated with ustekinumab (originator or biosimilar) and medically indicated to switch to guselkumab
- Investigator has decided to start guselkumab treatment
- Able and willing to complete patient-reported outcomes
- Signed informed consent form for data collection and verification
You will not qualify if you...
- Allergic reaction or hypersensitivity to guselkumab or any ingredient in its injection
- Pregnant or breastfeeding
- Currently enrolled in another interventional clinical study
- Currently enrolled in an observational study sponsored or managed by Janssen company
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants who switch from Ustekinumab to Guselkumab are observed in routine clinical practice to assess safety and effectiveness of Guselkumab.
Visits at baseline and approximately at Weeks 12, 28, and 52
Trial Site Locations
Total: 1 location
1
LKH-Univ. Klinikum Graz
Graz, Austria, 8036
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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