PsoriasisG-STARTNCT07746583
A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical Practice
An observational study of Psoriasis, run by Janssen-Cilag Kft. at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 3 Sep 2026to 15 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 20
Secondary outcomes (33)
Percentage of Participants Achieving aPASI <= 3 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: At Weeks 4, 12, 20, 36 and 52
Absolute Changes in PASI Score from 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: At Weeks 4, 12, 20, 36 and 52
Absolute Changes in DLQI Scores from 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: At Weeks 4, 12, 20, 36 and 52
Absolute Change in Scalp-Specific Investigator Global Assessment (ss-IGA) Score Over Time
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.
Measured: 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
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.
Measured: At Weeks 4, 12, 20, 36, and 52
Absolute Change in Fingernail Physician's Global Assessment (PGA-F) Score Over Time
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.
Measured: 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
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.
Measured: At Weeks 4, 12, 20, 36, and 52
Demographic Characteristics: Age
Participant's age at the time of starting guselkumab treatment will be reported.
Measured: At Baseline
Demographic Characteristics: Sex
Sex (male, female) of participants at the time of starting guselkumab treatment will be reported.
Measured: At Baseline
Demographic Characteristics: Weight
Weight of participants at the time of starting guselkumab treatment will be reported.
Measured: At Baseline
Demographic Characteristics: Height
Height of participants at the time of starting guselkumab treatment will be reported.
Measured: At Baseline
Clinical Characteristics: Time Since Psoriasis Diagnosis
Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported.
Measured: At Baseline
Clinical Characteristics: Time Since First Symptoms
Time since first symptoms (years), in participants starting guselkumab treatment will be reported.
Measured: At Baseline
Clinical Characteristics: Severity of Psoriasis
Severity of psoriasis (mild, moderate, severe) in participants starting guselkumab treatment will be reported.
Measured: At Baseline
Clinical Characteristics: Affected Areas
Affected areas (anogenital, nail, scalp, palmoplantar), in participants starting guselkumab treatment will be reported.
Measured: At Baseline
Clinical Characteristics: Prior and Baseline Treatments for Moderate to Severe Psoriasis
Prior and baseline treatments for moderate-to-severe psoriasis, including start and stop dates (in years) in participants starting guselkumab treatment will be reported.
Measured: At Baseline
Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab
Participants switching treatment and reason for switching treatment from Ustekinumab or biosimilars to Guselkumab will be reported.
Measured: At Baseline
Reason for Guselkumab Discontinuation
Number of participants discontinuing guselkumab and reason for guselkumab discontinuation if happens during the study will be reported.
Measured: Up to Week 52
Number of Participants with Specific Psoriatic Comorbidities
Specific psoriatic comorbidities at baseline will be reported.
Measured: At Baseline
Number of Participants with Adverse Events (AE)
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.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start3 Sep 2026
- Primary completion30 Jan 2029 (estimated)
- Study completion15 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Kft.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Kft. Clinical Trial, Study director, Janssen-Cilag Kft.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746583
- Sponsor's protocol ID
- CNTO1959PSO4038
- Other IDs
- CNTO1959PSO4038
- Acronym
- G-START
- Status last verified
- Nov 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07746583
- Acronym / sponsor ID
- G-START / CNTO1959PSO4038
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Janssen-Cilag Kft.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 15 Mar 2029 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
33 secondary outcomes
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 >= 75% Improvement in PASI (PASI 75) at Weeks 4, 12, 20, 36 and 52
Time frame: 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
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
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 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
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
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
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
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
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-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 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
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
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
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
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
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
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
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
Demographic Characteristics: Age
Time frame: At Baseline
Demographic Characteristics: Sex
Time frame: At Baseline
Demographic Characteristics: Weight
Time frame: At Baseline
Demographic Characteristics: Height
Time frame: At Baseline
Clinical Characteristics: Time Since Psoriasis Diagnosis
Time frame: At Baseline
Clinical Characteristics: Time Since First Symptoms
Time frame: At Baseline
Clinical Characteristics: Severity of Psoriasis
Time frame: At Baseline
Clinical Characteristics: Affected Areas
Time frame: At Baseline
Clinical Characteristics: Prior and Baseline Treatments for Moderate to Severe Psoriasis
Time frame: At Baseline
Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab
Time frame: At Baseline
Reason for Guselkumab Discontinuation
Time frame: Up to Week 52
Number of Participants with Specific Psoriatic Comorbidities
Time frame: At Baseline
Number of Participants with Adverse Events (AE)
Time frame: Up to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen-Cilag Kft. Clinical Trial study director
Janssen-Cilag Kft.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Janssen-Cilag Kft. at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.