Plaque psoriasis Skin and Connective Tissue Diseases
Conditions
Interventions
Experimental: Arm 1: JNJ 77242113
Participants will receive JNJ-77242113 once daily from Week 0 through Week 104. All participant will receive ustekinumab matching placebo at Week 0, 4 and 16 to maint
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 12 years of age or older at the screening visit. Note for the UK we will only be accepting participants aged 18 and older and will not be including adolescents in the trial 2. Diagnosis of moderate to severe plaque psoriasis, with or without PsA, for at least 26 weeks before the first administration of study intervention 3. Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline 4. Total psoriasis area and severity index (PASI) >=12 at screening and baseline 5. Total investigator global assessment (IGA) >=3 at screening and baseline 6. Candidate for phototherapy or systemic treatment for moderate to severe plaque psoriasis
Exclusion criteria
Exclusion criteria: 1. Nonplaque form of psoriasis (for example [e.g.], erythrodermic, guttate, or pustular) 2. Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) 3. Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients 4. Major surgical procedure within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study 5. Transplanted organ (with exception of a corneal transplant greater than [>] 12 weeks before the first administration of study intervention)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16 IGA score is given based on the investigator’s assessment of the participant’s plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant’s plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). 2. JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants achieving at least a 90 percent improvement from baseline in the PASI score. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response at Week 16 PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants achieving at least a 75 percent improvement from baseline in the PASI score. 2. JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16 PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants achieving at least a 100 percent improvement from baseline in the PASI score. 3. JNJ-77242113 and Placebo Group: Percentage of Participants with IGA Score of 0 at Week 16 4. IGA score is given based on the investigator’s assessment of the participant’s plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant’s plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or se | — |
Countries
Argentina, Australia, Belgium, Canada, Denmark, England, Germany, Hungary, Poland, Portugal, Spain, United Kingdom, United States of America
Outcome results
None listed