An observational study in Psoriasis, sponsored by Janssen-Cilag Kft.. Recruiting at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen-Cilag Kft. (part of Johnson & Johnson) · Observational
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.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's planned enrollment of 100 is below the median of 199 across 407 observational studies indexed under Psoriasis.
Browse Psoriasis studies →This is the only study on the registry with Janssen-Cilag Kft. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: At Week 20
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
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
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.
Time frame: 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.
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
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.
Time frame: At Weeks 4, 12, 20, 36, and 52
Demographic Characteristics: Age
Participant's age at the time of starting guselkumab treatment will be reported.
Time frame: At Baseline
Demographic Characteristics: Sex
Sex (male, female) of participants at the time of starting guselkumab treatment will be reported.
Time frame: At Baseline
Demographic Characteristics: Weight
Weight of participants at the time of starting guselkumab treatment will be reported.
Time frame: At Baseline
Demographic Characteristics: Height
Height of participants at the time of starting guselkumab treatment will be reported.
Time frame: At Baseline
Clinical Characteristics: Time Since Psoriasis Diagnosis
Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported.
Time frame: At Baseline
Clinical Characteristics: Time Since First Symptoms
Time since first symptoms (years), in participants starting guselkumab treatment will be reported.
Time frame: At Baseline
Clinical Characteristics: Severity of Psoriasis
Severity of psoriasis (mild, moderate, severe) in participants starting guselkumab treatment will be reported.
Time frame: At Baseline
Clinical Characteristics: Affected Areas
Affected areas (anogenital, nail, scalp, palmoplantar), in participants starting guselkumab treatment will be reported.
Time frame: 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.
Time frame: 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.
Time frame: At Baseline
Reason for Guselkumab Discontinuation
Number of participants discontinuing guselkumab and reason for guselkumab discontinuation if happens during the study will be reported.
Time frame: Up to Week 52
Number of Participants with Specific Psoriatic Comorbidities
Specific psoriatic comorbidities at baseline will be reported.
Time frame: 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.
Time frame: Up to Week 52
Plan to share: 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
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jan 2029, 28 months after the start.
Of 81 industry-sponsored observational studies under Psoriasis, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 74. This study's planned 28 months is below that.
Counting every sponsor, half of 173 studies reached it within 37 months; a quarter within 23 and three quarters within 93.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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