Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) |
The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease. |
Week 16 |
|
Primary |
Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 75 Response |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas are 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 percent [%] to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 75 response represents at least a 75% improvement from baseline in the PASI score. |
Week 16 |
|
Secondary |
Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was 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 percent [%] to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents at least a 90% improvement from baseline in the PASI score. |
Week 16 |
|
Secondary |
Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) |
The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease. |
Week 16 |
|
Secondary |
Part 1 and 2: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) |
The CDLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a child's QoL. The CDLQI, a 10-item questionnaire has 4-item response options and a recall period of 1 week. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater the impairment in QoL. |
Baseline, Week 16 (Part 1) and up to Week 52 (Part 2) |
|
Secondary |
Part 1: Percentage of Participants who Achieve PASI 100 Response |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was 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% to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 100 response represents 100% improvement from baseline in the PASI score (i.e., a PASI score of 0). |
Week 16 |
|
Secondary |
Part 1: Percentage of Retreated Participants who Achieve a PASI 90 Response Over Time After Retreatment |
Participants randomized to guselkumab who are PASI 90 responders at Week 16 will be withdrawn from treatment and upon loss of >=50% of the improvement in PASI achieved at Week 16, they will be retreated with guselkumab. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was 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% to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents at least a 90% improvement from baseline in the PASI score. |
Every 4 weeks after retreatment is initiated, until Week 52 |
|
Secondary |
Part 1: Percentage of Retreated Participants who Achieve PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment |
Participants randomized to guselkumab who are PASI 90 responders at Week 16 will be withdrawn from treatment and upon loss of >=50% of the improvement in PASI achieved at Week 16, they will be retreated with guselkumab. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 50, 75, 90 and 100 response represents at least 50, 75, 90 and 100% improvement from baseline respectively, in the PASI score. |
Every 4 weeks after retreatment is initiated, until Week 52 |
|
Secondary |
Part 1: Percentage of Retreated Participants who Achieve IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment |
Participants randomized to guselkumab who are PASI 90 responders at Week 16 will be withdrawn from treatment and upon loss of >=50% of the improvement in PASI achieved at Week 16, these participants will be retreated with guselkumab. The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease. |
Every 4 weeks after retreatment is initiated, until Week 52 |
|
Secondary |
Part 1: Time to Loss of 50% of the Week 16 PASI Improvement After Withdrawal |
Loss of 50% of PASI improvement is defined as a loss of >=50% of the improvement in PASI at Week 16 after treatment is withdrawn. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was 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% to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. |
Week 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
Secondary |
Part 1: Time to Loss of PASI 90 Response After Withdrawal |
Loss of PASI 90 Response is defined as <90% improvement in PASI from baseline after Week 16 in a participant who had achieved >=90% improvement in PASI from baseline at Week 16. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was 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% to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents at least a 90% improvement from baseline in the PASI score. |
Week 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
Secondary |
Part 1: Percentage of Participants who Achieve a PASI 50 Response |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was 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% to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 50 response represents at least a 50% improvement from baseline in the PASI score. |
Week 16 |
|
Secondary |
Part 1: Percentage of Participants who Achieve an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) |
The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease. |
Week 16 |
|
Secondary |
Part 1 and 2: Percent Change From Baseline in PASI Over Time |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was 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% to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. |
Baseline, up to Week 16 (Part 1); up to Week 52 (Part 2) |
|
Secondary |
Part 1 and 2: Percentage of Participants with PASI Responses (PASI 50, 75, 90, and 100) Over Time |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was 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% to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 50, 75, 90, and 100 responses represents at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score. |
Up to Week 16 (Part 1); up to Week 52 (Part 2) |
|
Secondary |
Part 1 and 2: Percentage of Participants with IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time |
The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease. |
Up to Week 16 (Part 1); up to Week 52 (Part 2) |
|
Secondary |
Part 1 and 2: Percentage of Participants with CDLQI equal to (=) 0 or 1 Among Participants with a Baseline CDLQI Greater Than (>) 1 |
The CDLQI is a dermatology-specific QoL instrument designed to assess the impact of the disease on a child's QoL. The CDLQI, a 10-item questionnaire has 4 item response options and a recall period of 1 week. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in QoL. |
At Week 16 (Part 1); up to Week 52 (Part 2) |
|
Secondary |
Part 1 and 2: Percentage of Participants with Family Dermatology Life Quality Index (FDLQI)=0 or 1 Among Participants with a Baseline FDLQI >1 |
The FDLQI is a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member. Each item has a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranges from 0 to 30; a higher score indicates greater impairment of QoL. This instrument should be completed by a participant's primary care-giver. |
At Week 16 (Part 1); up to Week 52 (Part 2) |
|
Secondary |
Part 1 and 2: Change From Baseline in FDLQI Score |
The FDLQI is a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member. Each item has a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranges from 0 to 30; a higher score indicates greater impairment of QoL. This instrument should be completed by a participant's primary care-giver. |
Baseline, Week 16 (Part 1); up to Week 52 (Part 2) |
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