A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis

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.

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.

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).

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).

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.

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.

PSSD includes patient-reported outcome (PRO) questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.

PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.

An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any untoward medical occurrence that results in: death, is life-threatening, requires in-patient hospitalization/prolongs existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of infectious agent via medicinal product \& is medically important.

PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. This PRO includes 11 items in total, with 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). A 0 to 10 numerical rating scale for severity is used to rank the psoriasis sign score. A higher score indicates more severe disease.

DLQI will be utilized in the adult population and is a dermatology specific health related quality of life (HRQoL) instrument designed to assess the impact of the disease on the HRQoL It is a 10-item questionnaire that can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.

DLQI will be utilized in the adult population and is a dermatology specific HRQoL instrument designed to assess the impact of the disease on the HRQoL It is a 10 item questionnaire that can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.

BSA is a commonly used measure of involvement of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed, (that is., plaque psoriasis). The handprint method for assessing BSA will be used, where the surface area of the participant's hand including the palm and all 5 digits is used as a guide to estimate 1% BSA.

PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.

PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.

PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.

PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.

PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.

DLQI will be utilized in the adult population and is a dermatology specific HRQoL instrument designed to assess the impact of the disease on the HRQoL It is a 10-item questionnaire that can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.

DLQI will be utilized in the adult population and is a dermatology specific HRQoL instrument designed to assess the impact of the disease on the HRQoL. It is a 10-item questionnaire that can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.

BSA is a commonly used measure of involvement of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed, (ie, plaque psoriasis). The handprint method for assessing BSA will be used, where the surface area of the participant's hand including the palm and all 5 digits is used as a guide to estimate 1% BSA.

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).

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.

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.