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

NCT07449234 | Recruiting

• 1 other identifier: CNTO1959PSO4032
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) Score Less Than or Equal to (<=) 3 after Switching to Guselkumab at Week 28

  The PASI is a standardized scoring method for assessing and grading the severity of a participant's psoriasis. PASI yields a numeric score ranging from 0 (skin completely free of symptoms) to 72 (maximum expression of psoriasis), with higher scores indicating more severe psoriasis.

  At Week 28

Secondary Outcomes (39)

• Percentage of Participants Achieving a PASI Score <= 3 after Switching to Guselkumab at Weeks 12 and 52

  At Weeks 12 and 52

• Percentage of Participants Achieving a Greater Than or Equal to (>=) 90 Percent (%) Improvement in PASI Score (PASI 90) from Baseline at Weeks 12, 28 and 52

  At Weeks 12, 28 and 52

• Percentage of Participants Achieving 100% Improvement in PASI Score (PASI 100) from Baseline at Weeks 12, 28 and 52

  At Weeks 12, 28 and 52

• Number of Participants with Absolute PASI Course from Baseline to Week 52

  Baseline up to Week 52

• Absolute Change from Baseline In PASI Scores at Week 52

  Baseline up to Week 52

Study Arms (1)

Guselkumab: Switch from Ustekinumab

Participants with moderate-to-severe psoriasis who are candidates for systemic treatment (according to the Guselkumab label) and who are medically indicated to switch from Ustekinumab or its biosimilar to Guselkumab can be included in this study. Only data available per clinical practice will be collected within this study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with moderate-to-severe plaque psoriasis who are currently being treated with Ustekinumab or its biosimilar, who are candidates for systemic treatment and medically indicated to switch to Guselkumab will be included in this study. Participating sites will include hospitals and outpatient/off-clinic settings.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (1)

LKH-Univ. Klinikum Graz

Graz, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janssen- Cilag Pharma Clinical Trial

  Janssen- Cilag Pharma

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)