A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis (G-LINK)

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • LKH-Univ. Klinikum Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Week 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	At Weeks 12, 28 and 52
Demographic Characteristics: Age	Participant's age at the time of starting guselkumab treatment will be reported.	Baseline
Demographic Characteristics: Sex	Sex (male, female) of participants at the time of starting guselkumab treatment will be reported.	Baseline
Demographic Characteristics: Weight	Weight of participants at the time of starting guselkumab treatment will be reported.	Baseline
Demographic Characteristics: Height	Height of participants at the time of starting guselkumab treatment will be reported.	Baseline
Clinical Characteristics: Time Since Psoriasis Diagnosis	Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported.	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.	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.	Baseline
Treatment Patterns: Dose of the Treatment	Patterns of treatment (dose) with Guselkumab during the observational period will be reported.	Up to Week 52
Treatment Patterns: Frequency of the Treatment	Patterns of treatment (frequency) with Guselkumab during the observational period will be reported.	Up to Week 52
Number of Participants with Specific Psoriatic Comorbidities	Specific psoriatic comorbidities at baseline will be reported.	Baseline
Number of Participants with Other Comorbidities	Other comorbidities at baseline will be reported.	Baseline
Number of Participants Receiving Concomitant Medications for Specific Psoriatic Comorbidities	Concomitant medications for specific psoriatic comorbidities during the observational period will be reported.	Up to Week 52

Collaborators and Investigators

• Sponsor: Janssen-Cilag Ltd.
• Investigators: Study Director: Janssen- Cilag Pharma Clinical Trial, Janssen- Cilag Pharma

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis
• Other Study ID Numbers: CNTO1959PSO4032 (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.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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No