A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis
ConditionPsoriasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen-Cilag Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Guselkumab: Switch from Ustekinumab
Trial outcomes
Primary outcomes
1
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.
Time frame
At Week 28Secondary outcomes
1
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.
Time frame
At Weeks 12 and 522
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.
Time frame
At Weeks 12, 28 and 523
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.
Time frame
At Weeks 12, 28 and 524
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.
Time frame
Baseline up to Week 52Sponsors and contacts
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Source ClinicalTrials.gov