Guselkumab after switching from ustekinumab for 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
This study will try guselkumab in people with moderate to severe psoriasis who are switching from ustekinumab to see how well it works and how safe it is in routine clinical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen-Cilag Ltd. Industry-sponsored |
| Drugs / interventions | Ustekinumab, Guselkumab |
| Locations | 1 site (Graz) |
| Trial ID | NCT07449234 on ClinicalTrials.gov |
What this trial studies
This observational study follows patients with moderate-to-severe plaque psoriasis who, per their doctor's decision, switch from ustekinumab (originator or biosimilar) to guselkumab in routine practice. Investigators will collect data on effectiveness, safety, and patient-reported outcomes while treatment is managed according to usual care. Participants must be able to complete PROs and consent to source data verification. The study is sponsored by Janssen-Cilag Ltd. and conducted at LKH-Univ. Klinikum Graz in Graz, Austria.
Who should consider this trial
Good fit: Adults with confirmed moderate-to-severe plaque psoriasis who are currently on ustekinumab and whose physician decides they should switch to guselkumab, who can complete patient-reported outcomes and give informed consent.
Not a fit: Patients with known hypersensitivity to guselkumab, pregnant or breastfeeding individuals, or those already enrolled in conflicting interventional or Janssen-managed observational studies are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, this could help show whether switching to guselkumab provides better disease control or tolerability for patients who need to change biologic therapy.
How similar studies have performed: Randomized trials and real-world studies have shown guselkumab is effective for moderate-to-severe psoriasis, and switching from ustekinumab to an IL-23 inhibitor has been supported by prior evidence.
Eligibility criteria
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 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 criteria: * 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
Where this trial is running
Graz
- LKH-Univ. Klinikum Graz — Graz, Austria (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.