A Study to Evaluate Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Participants of Moderate-to-severe Plaque Psoriasis

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

An AE is any untoward medical occurrence in a participant during a clinical study that does not have a causal relationship with the pharmaceutical/biological agent under study.

Number of participants with change from baseline in laboratory abnormalities (chemistry, hematology) will be reported.

Number of participants with abnormalities of electrocardiogram will be reported.

Number of participants with change from baseline in vital signs (temperature, heart rate, respiratory rate, blood pressure) will be reported.

Number of participants with change from baseline in physical examination will be reported.

Number of participants with change from baseline in concomitant medications will be reported.

An injection-site reaction is any favorable or unintended sigh that occurs at the study drug injection site. Injection sites will be evaluated for reactions and any injection-site reaction will be recorded as an AE.

Number of participants with allergic reactions (skin symptoms such as urticaria, erythema, and itching; respiratory symptoms such as dyspnea, wheezing; gastrointestinal symptoms such as nausea, vomiting, and abdominal pain; and severe allergic symptoms including angioedema, sudden drop of blood pressure, or even anaphylactic shock) will be reported.

Number of participants with infections including serious infections, and infections requiring oral or parenteral antimicrobial treatment will be reported.

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 100, 75, and 50 response is defined as 100%, >=75%, and >=50% improvement in PASI score respectively.

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response is defined as >=90% improvement in PASI score.

Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) over time will be reported.

The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10 item patient-reported outcome(s) (PRO) questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates more severe disease.

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response is defined as >=90% improvement in PASI score.

Percentage of participants who maintain IGA score of cleared (0) or minimal (1) at Week 86 among participants who achieved IGA0/1 at Week 48 will be reported

Percentage of participants who achieve an IGA score of cleared (0) and an IGA score of mild or better (<=2) over time will be reported.

Percentage of participants who achieve a DLQI score of 0 or 1 over time among participants with baseline DLQI > 1 will be reported.

Percentage of participants with a reduction of 5 or more points in DLQI score over time will be reported.

The NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0-4 (A higher score indicates more severity). The sum of these scores is the total NAPSI score (0=no psoriasis to 8=psoriasis present in all 4 quadrants of the target nail).

The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.