PsoriasisG-LINKNCT07449234
A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis
An observational study of Psoriasis, run by Janssen-Cilag Ltd. at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 9 participants
- Where
- 1 siteAustria
- Study dates
- 9 Feb 2026to 29 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
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 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
- 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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 28
Secondary outcomes (39)
Percentage of Participants Achieving a PASI Score <= 3 after Switching to Guselkumab at Weeks 12 and 52
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.
Measured: 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
Percentage of participants achieving >=90% improvement in PASI score at Weeks 12, 28 and 52 will be reported. 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.
Measured: 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
Percentage of participants achieving 100% improvement in PASI score from baseline at Weeks 12, 28 and 52 will be reported. 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.
Measured: At Weeks 12, 28 and 52
Number of Participants with Absolute PASI Course from Baseline to Week 52
Absolute PASI course refers to how a participant's absolute PASI score changes over time during treatment.
Measured: Baseline up to Week 52
Absolute Change from Baseline In PASI Scores at Week 52
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. Absolute changes in PASI scores, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Relative Change from Baseline In PASI Score at Week 52
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. Relative changes in PASI scores, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Absolute Change from Baseline in Body Surface Area (BSA) Score at Week 52
BSA indicates the percentage of the total body surface area affected by psoriasis. The maximum value for BSA is 100. Absolute changes in BSA scores from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Relative Change from Baseline in BSA Score at Week 52
BSA indicates the percentage of the total body surface area affected by psoriasis. The maximum value for BSA is 100. Relative changes in BSA scores from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Absolute Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 52
DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. Absolute changes in DLQI scores, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Relative Change from Baseline in DLQI Score at Week 52
DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. Relative changes in DLQI scores, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 12, 28, and 52
DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. Percentage of participants achieving DLQI score of 0 or 1 at Weeks 12, 28, and 52 will be reported.
Measured: At Weeks 12, 28 and 52
Absolute Change from Baseline in World Health Organization-5 (WHO-5) Well-Being Index Questionnaire Score at Week 52
WHO-5 is a self-report measure comprising 5 items about psychological well-being. All items are answered on a 5-point Likert scale that ranges from 0 (at no time) to 4 (all of the time). A higher score indicates more pronounced psychological well-being. Absolute changes in WHO-5 scores, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Relative Change from Baseline in WHO-5 Well-Being Index Questionnaire Score at Week 52
WHO-5 is a self-report measure comprising 5 items about psychological well-being. All items are answered on a 5-point Likert scale that ranges from 0 (at no time) to 4 (all of the time). A higher score indicates more pronounced psychological well-being. Relative changes in WHO-5 scores, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Absolute Change From Baseline in Worst Itch Numeric Rating Scores (WI-NRS) at Week 52
The WI-NRS is a single-item, patient-reported questionnaire designed to measure an individual's "worst itch" over the past 24 hours on an 11-point rating scale, where 0 represents "no itch" and 10 represents "the worst itching imaginable." A higher score indicates worse itch. Absolute changes in worst itch numeric rating scale (WI-NRS) scores, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Relative Change from Baseline in WI-NRS at Week 52
The WI-NRS is a single-item, patient-reported questionnaire designed to measure an individual's "worst itch" over the past 24 hours on an 11-point rating scale, where 0 represents "no itch" and 10 represents "the worst itching imaginable." A higher score indicates worse itch. Relative changes in worst itch numeric rating scale (WI-NRS) scores, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Absolute Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI: PSO) Scores at Week 52
WPAI is a 6-item instrument designed to measure impairments in work and activities over the past 7 days. WPAI outcomes are expressed as percentages of impairment, with higher percentages indicating greater impairment and reduced productivity, meaning worse outcomes. Absolute changes in WPAI: PSO scores, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Relative Change from Baseline in WPAI:PSO Scores at Week 52
WPAI is a 6-item instrument designed to measure impairments in work and activities over the past 7 days. WPAI outcomes are expressed as percentages of impairment, with higher percentages indicating greater impairment and reduced productivity, meaning worse outcomes. Relative changes in WPAI: PSO scores, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Absolute Change from Baseline in Anogenital Physician's Global Assessment (PGA) Score at Week 52
The Anogenital PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. In participants with anogenital psoriasis at baseline, absolute changes in Anogenital PGA score, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Percentage of Participants Achieving Anogenital PGA Score of 0 at Weeks 12, 28, and 52
The Anogenital PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. In participants with anogenital psoriasis at baseline, the percentage of participants achieving anogenital PGA Score of 0 at Weeks 12, 28, and 52 will be reported.
Measured: At Weeks 12, 28 and 52
Absolute Change from Baseline in Palmoplantar PGA Score at Week 52
The Palmoplantar PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. In participants with palmoplantar psoriasis at baseline, absolute changes in Palmoplantar PGA score, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Percentage of Participants Achieving Palmoplantar PGA Score of 0 at Weeks 12, 28, and 52
The Palmoplantar PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. In participants with palmoplantar psoriasis at baseline, the percentage of participants achieving anogenital PGA score of 0 at Weeks 12, 28, and 52 will be reported.
Measured: At Weeks 12, 28 and 52
Absolute Change from Baseline in Scalp PGA Score at Week 52
The Scalp PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. In participants with scalp psoriasis at baseline, absolute changes in Scalp PGA score, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Percentage of Participants Achieving Scalp PGA Score of 0 at Weeks 12, 28, and 52
The Scalp PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. In participants with scalp psoriasis at baseline, the percentage of participants achieving Scalp PGA score of 0 at Weeks 12, 28, and 52 will be reported.
Measured: At Weeks 12, 28 and 52
Absolute Change from Baseline in Scalp Itch Numeric Rating Scales (NRS) at Week 52
The Scalp Itch NRS is a single-item, patient-reported questionnaire designed to measure an individual's "worst itch" over the past 24 hours on an 11-point rating scale, where 0 represents "no itch" and 10 represents "the worst itching imaginable." A higher score indicates more itch. In participants with scalp psoriasis at baseline, absolute changes in scalp itch Numeric Rating Scale (NRS) scores, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Relative Change from Baseline in Scalp Itch NRS at Week 52
The Scalp Itch NRS is a single-item, patient-reported questionnaire designed to measure an individual's "worst itch" over the past 24 hours on an 11-point rating scale, where 0 represents "no itch" and 10 represents "the worst itching imaginable." A higher score indicates more itch. In participants with scalp psoriasis at baseline, relative changes in scalp itch NRS scores, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Relative Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 52
The NAPSI is designed to evaluate the presence or absence of nail matrix and nail bed psoriasis in the four quadrants of 10 fingernails. Only participants with nail psoriasis at baseline will be evaluated using NAPSI. The worst affected nail will be selected for each participant at baseline, and this specific nail will be evaluated throughout the study, with a score ranging from 0-8 where higher scores indicate more severe nail psoriasis. In participants with nail psoriasis at baseline, relative changes in NAPSI score, from baseline to Week 52 will be reported.
Measured: Baseline up to Week 52
Percentage of Participants Achieving NAPSI Score of 0 at Weeks 12, 28, and 52
The NAPSI is designed to evaluate the presence or absence of nail matrix and nail bed psoriasis in the four quadrants of 10 fingernails. Only participants with nail psoriasis at baseline will be evaluated using NAPSI. The worst affected nail will be selected for each participant at baseline, and this specific nail will be evaluated throughout the study, with a score ranging from 0-8 where higher scores indicate more severe nail psoriasis. In participants with nail psoriasis at baseline, the percentage of participants achieving NAPSI Score of 0 at Weeks 12, 28, and 52 will be reported.
Measured: At Weeks 12, 28 and 52
Demographic Characteristics: Age
Participant's age at the time of starting guselkumab treatment will be reported.
Measured: Baseline
Demographic Characteristics: Sex
Sex (male, female) of participants at the time of starting guselkumab treatment will be reported.
Measured: Baseline
Demographic Characteristics: Weight
Weight of participants at the time of starting guselkumab treatment will be reported.
Measured: Baseline
Demographic Characteristics: Height
Height of participants at the time of starting guselkumab treatment will be reported.
Measured: Baseline
Clinical Characteristics: Time Since Psoriasis Diagnosis
Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported.
Measured: Baseline up to Week 52
Clinical Characteristics: Prior Treatments for Moderate to Severe Psoriasis
Prior treatments for moderate-to-severe psoriasis, including start and stop dates in participants starting guselkumab treatment will be reported.
Measured: 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: Baseline
Treatment Patterns: Dose of the Treatment
Patterns of treatment (dose) with Guselkumab during the observational period will be reported.
Measured: Up to Week 52
Treatment Patterns: Frequency of the Treatment
Patterns of treatment (frequency) with Guselkumab during the observational period will be reported.
Measured: Up to Week 52
Number of Participants with Specific Psoriatic Comorbidities
Specific psoriatic comorbidities at baseline will be reported.
Measured: Baseline
Number of Participants with Other Comorbidities
Other comorbidities at baseline will be reported.
Measured: Baseline
Number of Participants Receiving Concomitant Medications for Specific Psoriatic Comorbidities
Concomitant medications for specific psoriatic comorbidities during the observational period will be reported.
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 posted4 Mar 2026
- Study start9 Feb 2026
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Why it stopped: Study terminated due to insufficient enrollment.
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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen- Cilag Pharma Clinical Trial, Study director, Janssen- Cilag Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449234
- Sponsor's protocol ID
- CNTO1959PSO4032
- Other IDs
- CNTO1959PSO4032
- Acronym
- G-LINK
- Status last verified
- Jul 2026
- First submitted
- 27 Feb 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/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 27 Jul 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
- NCT07449234
- Acronym / sponsor ID
- G-LINK / CNTO1959PSO4032
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated due to insufficient enrollment.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 4 Mar 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
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 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 a Psoriasis Area and Severity Index (PASI) Score Less Than or Equal to (<=) 3 after Switching to Guselkumab at Week 28
Time frame: 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.
39 secondary outcomes
Percentage of Participants Achieving a PASI Score <= 3 after Switching to Guselkumab at Weeks 12 and 52
Time frame: 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
Time frame: 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
Time frame: At Weeks 12, 28 and 52
Number of Participants with Absolute PASI Course from Baseline to Week 52
Time frame: Baseline up to Week 52
Absolute Change from Baseline In PASI Scores at Week 52
Time frame: Baseline up to Week 52
Relative Change from Baseline In PASI Score at Week 52
Time frame: Baseline up to Week 52
Absolute Change from Baseline in Body Surface Area (BSA) Score at Week 52
Time frame: Baseline up to Week 52
Relative Change from Baseline in BSA Score at Week 52
Time frame: Baseline up to Week 52
Absolute Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 52
Time frame: Baseline up to Week 52
Relative Change from Baseline in DLQI Score at Week 52
Time frame: Baseline up to Week 52
Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 12, 28, and 52
Time frame: At Weeks 12, 28 and 52
Absolute Change from Baseline in World Health Organization-5 (WHO-5) Well-Being Index Questionnaire Score at Week 52
Time frame: Baseline up to Week 52
Relative Change from Baseline in WHO-5 Well-Being Index Questionnaire Score at Week 52
Time frame: Baseline up to Week 52
Absolute Change From Baseline in Worst Itch Numeric Rating Scores (WI-NRS) at Week 52
Time frame: Baseline up to Week 52
Relative Change from Baseline in WI-NRS at Week 52
Time frame: Baseline up to Week 52
Absolute Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI: PSO) Scores at Week 52
Time frame: Baseline up to Week 52
Relative Change from Baseline in WPAI:PSO Scores at Week 52
Time frame: Baseline up to Week 52
Absolute Change from Baseline in Anogenital Physician's Global Assessment (PGA) Score at Week 52
Time frame: Baseline up to Week 52
Percentage of Participants Achieving Anogenital PGA Score of 0 at Weeks 12, 28, and 52
Time frame: At Weeks 12, 28 and 52
Absolute Change from Baseline in Palmoplantar PGA Score at Week 52
Time frame: Baseline up to Week 52
Percentage of Participants Achieving Palmoplantar PGA Score of 0 at Weeks 12, 28, and 52
Time frame: At Weeks 12, 28 and 52
Absolute Change from Baseline in Scalp PGA Score at Week 52
Time frame: Baseline up to Week 52
Percentage of Participants Achieving Scalp PGA Score of 0 at Weeks 12, 28, and 52
Time frame: At Weeks 12, 28 and 52
Absolute Change from Baseline in Scalp Itch Numeric Rating Scales (NRS) at Week 52
Time frame: Baseline up to Week 52
Relative Change from Baseline in Scalp Itch NRS at Week 52
Time frame: Baseline up to Week 52
Relative Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 52
Time frame: Baseline up to Week 52
Percentage of Participants Achieving NAPSI Score of 0 at Weeks 12, 28, and 52
Time frame: At Weeks 12, 28 and 52
Demographic Characteristics: Age
Time frame: Baseline
Demographic Characteristics: Sex
Time frame: Baseline
Demographic Characteristics: Weight
Time frame: Baseline
Demographic Characteristics: Height
Time frame: Baseline
Clinical Characteristics: Time Since Psoriasis Diagnosis
Time frame: Baseline up to Week 52
Clinical Characteristics: Prior Treatments for Moderate to Severe Psoriasis
Time frame: Baseline
Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab
Time frame: Baseline
Treatment Patterns: Dose of the Treatment
Time frame: Up to Week 52
Treatment Patterns: Frequency of the Treatment
Time frame: Up to Week 52
Number of Participants with Specific Psoriatic Comorbidities
Time frame: Baseline
Number of Participants with Other Comorbidities
Time frame: Baseline
Number of Participants Receiving Concomitant Medications for Specific Psoriatic Comorbidities
Time frame: Up to Week 52
Results and safety
The study was stopped early (reason given: Study terminated due to insufficient enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/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. This study is not recruiting at the moment.
Janssen- Cilag Pharma Clinical Trial study director
Janssen- Cilag Pharma
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 Ltd. at 1 site in Austria.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 27 Jul 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 Austria. 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?
The study was stopped early (reason given: Study terminated due to insufficient enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: At Week 28). 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 27 Jul 2026.