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

NCT07746583 | Recruiting

• 1 other identifier: CNTO1959PSO4038
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Absolute Psoriasis Area Severity Index (aPASI) <=3 at Week 20 Following Switch from Ustekinumab to Guselkumab

  Percentage of participants achieving aPASI less than or equal to (\<=) 3 at Week 20 following the switch from Ustekinumab to Guselkumab will be reported. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

  At Week 20

Secondary Outcomes (33)

• Percentage of Participants Achieving aPASI <= 3 at Weeks 4, 12, 36 and 52

  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

  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

  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

  At Weeks 4, 12, 20, 36 and 52

• Absolute Changes in PASI Score from Baseline up to Weeks 4, 12, 20, 36 and 52

  Baseline up to Weeks 4, 12, 20, 36 and 52

Study Arms (1)

Moderate to Severe Psoriasis: Guselkumab Switching 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 receive Guselkumab in routine clinical practice will be enrolled. No drug will be provided as a part of this study. Only data available from routine clinical practice will be collected.

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 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Kft.: lead

Study Sites (1)

Semmelweis University

Budapest, 1088, Hungary

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen-Cilag Kft. Clinical Trial

  Janssen-Cilag Kft.

  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: July 29, 2026
• First Posted: August 5, 2026
• Study Start: September 3, 2026
• Primary Completion (Estimated): January 30, 2029
• Study Completion (Estimated): March 15, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

HU (1)