A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical Practice (G-START)

August 27, 2026 updated by: Janssen-Cilag Kft.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hungary
      • Budapest, Hungary, 1088
        • Recruiting
        • Semmelweis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 aPASI <= 3 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 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
Participants with an absolute percentage improvement of at least 75% will be considered having achieved PASI 75 at Weeks 4, 12, 20, 36 and 52. 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 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
Participants with an absolute percentage improvement of at least 90% will be considered having achieved PASI 90 at Weeks 4, 12, 20, 36 and 52. 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 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
Participants with an absolute percentage improvement of 100% will be considered having achieved PASI 100 at Weeks 4, 12, 20, 36 and 52. 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 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 PASI scores from baseline to Weeks 4, 12, 20, 36 and 52 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.
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
Absolute changes in BSA scores from baseline upto Weeks 4, 12, 20, 36 and 52 will be reported. BSA indicates the percentage of the total body surface area affected by psoriasis. For small-spotted psoriasis lesions, healthy skin between the lesions is not included in the assessment. BSA ranges from 0-100 in which the maximum value is 100.
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
DLQI is a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question is evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. Scores from all 10 questions are added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants.
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
The DLQI-R is calculated by summing the scores of all answered items on the 10-question DLQI questionnaire (each scored 0-3), excluding those marked as "not relevant" (NRR). The total DLQI-R score ranges from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants.
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
DLQI is a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question is evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. Scores from all 10 questions are added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants.
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
The DLQI-R is calculated by summing the scores of all answered items on the 10-question DLQI questionnaire (each scored 0-3), excluding those marked as "not relevant" (NRR). The total DLQI-R score ranges from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants.
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 scores from baseline to Week 4, 12, 20, 36 and 52 will be reported. DLQI is a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. The total DLQI score ranges from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants.
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
Absolute changes in DLQI-R scores from baseline to Week 4, 12, 20, 36 and 52 will be reported. The DLQI-R is calculated by summing the scores of all answered items on the 10-question DLQI questionnaire (each scored 0-3), excluding those marked as "not relevant" (NRR). The total DLQI-R score ranges from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants.
Baseline up to Weeks 4, 12, 20, 36 and 52
Absolute Change in Static Physician's Global Assessment of Genitalia (sPGA-G) Score Over Time
Time Frame: Baseline up to Weeks 4, 12, 20, 36 and 52
In participants with anogenital psoriasis at baseline, absolute change in sPGA-G score over time will be reported. The sPGA-G describes the severity of psoriasis using 6 categories. Accordingly, the score ranges from 0-5, with higher scores indicating more severe psoriasis.
Baseline up to Weeks 4, 12, 20, 36 and 52
Percentage of Participants Achieving sPGA-G Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52
Time Frame: At Weeks 4, 12, 20, 36 and 52
In participants with anogenital psoriasis at baseline, the percentage of participants achieving sPGA-G score of 0 or 1 amongst the participants who had a >= 2 sPGA-G score at baseline will be reported. The sPGA-G describes the severity of psoriasis using 6 categories. Accordingly, the score ranges from 0-5, with higher scores indicating more severe psoriasis.
At Weeks 4, 12, 20, 36 and 52
Absolute Change in Physician´s Global Assessment of Hands and/or Feet (hf-PGA) Score Over Time
Time Frame: Baseline up to Weeks 4, 12, 20, 36 and 52
In participants with palmoplantar psoriasis at baseline, absolute change in hf-PGA score over time will be reported. The hf-PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis.
Baseline up to Weeks 4, 12, 20, 36 and 52
Percentage of Participants Achieving hf-PGA Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52
Time Frame: At Weeks 4, 12, 20, 36 and 52
In participants with palmoplantar psoriasis at baseline, percentage of participants achieving hf-PGA = 0 or 1 amongst the participants who had a >= 2 hf-PGA at baseline will be reported. The hf-PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis.
At Weeks 4, 12, 20, 36 and 52
Absolute Change in Scalp-Specific Investigator Global Assessment (ss-IGA) Score Over Time
Time Frame: Baseline up to Weeks 4, 12, 20, 36, and 52
In participants with scalp psoriasis at baseline, the absolute change in ss-IGA score over time will be reported. The ss-IGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis.
Baseline up to Weeks 4, 12, 20, 36, and 52
Percentage of Participants Achieving ss-IGA Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52
Time Frame: At Weeks 4, 12, 20, 36, and 52
In participants with scalp psoriasis at baseline, the percentage of participants achieving ss-IGA of 0 or 1 amongst the participants who had a >= 2 ss-IGA score at baseline will be reported. The ss-IGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis.
At Weeks 4, 12, 20, 36, and 52
Absolute Change in Fingernail Physician's Global Assessment (PGA-F) Score Over Time
Time Frame: Baseline up to Weeks 4, 12, 20, 36, and 52
In participants with fingernail psoriasis at baseline, absolute change in PGA-F score over time will be reported. The PGA-F describes the severity of psoriasis using 5 categories and consists of scores ranging from 0 (Clear), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Severe). Here, higher scores indicate more severity of psoriasis.
Baseline up to Weeks 4, 12, 20, 36, and 52
Percentage of Participants Achieving PGA-F Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52
Time Frame: At Weeks 4, 12, 20, 36, and 52
In participants with fingernail psoriasis at baseline, the percentage of participants achieving PGA-F score of 0 or 1 amongst participants who had a >=2 PGA-F at baseline will be reported. The PGA-F describes the severity of psoriasis using 5 categories and consists of scores ranging from 0 (Clear), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Severe). Here, higher scores indicate more severity of psoriasis.
At Weeks 4, 12, 20, 36, and 52
Demographic Characteristics: Age
Time Frame: At Baseline
Participant's age at the time of starting guselkumab treatment will be reported.
At Baseline
Demographic Characteristics: Sex
Time Frame: At Baseline
Sex (male, female) of participants at the time of starting guselkumab treatment will be reported.
At Baseline
Demographic Characteristics: Weight
Time Frame: At Baseline
Weight of participants at the time of starting guselkumab treatment will be reported.
At Baseline
Demographic Characteristics: Height
Time Frame: At Baseline
Height of participants at the time of starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Time Since Psoriasis Diagnosis
Time Frame: At Baseline
Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Time Since First Symptoms
Time Frame: At Baseline
Time since first symptoms (years), in participants starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Severity of Psoriasis
Time Frame: At Baseline
Severity of psoriasis (mild, moderate, severe) in participants starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Affected Areas
Time Frame: At Baseline
Affected areas (anogenital, nail, scalp, palmoplantar), in participants starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Prior and Baseline Treatments for Moderate to Severe Psoriasis
Time Frame: At Baseline
Prior and baseline treatments for moderate-to-severe psoriasis, including start and stop dates (in years) in participants starting guselkumab treatment will be reported.
At Baseline
Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab
Time Frame: At Baseline
Participants switching treatment and reason for switching treatment from Ustekinumab or biosimilars to Guselkumab will be reported.
At Baseline
Reason for Guselkumab Discontinuation
Time Frame: Up to Week 52
Number of participants discontinuing guselkumab and reason for guselkumab discontinuation if happens during the study will be reported.
Up to Week 52
Number of Participants with Specific Psoriatic Comorbidities
Time Frame: At Baseline
Specific psoriatic comorbidities at baseline will be reported.
At Baseline
Number of Participants with Adverse Events (AE)
Time Frame: Up to Week 52
An AE is any untoward medical occurrence in a participant administered with a pharmaceutical product. An AE does not necessarily have a causal relationship with the treatment.
Up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag Kft.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen-Cilag Kft. Clinical Trial, Janssen-Cilag Kft.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CNTO1959PSO4038 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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