Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study will assess the change in disease symptoms. Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. This study has 4 parts. Part 1: Participants aged 12 \< 18 will receive a fixed dose of risankizumab. Part 2: Participants aged 12 \< 18 will receive; * Period A: Risankizumab or ustekinumab based on body weight followed by; * Period B: Risankizumab or no treatment. * Period C: Re-treatment with risankizumab (if needed). Part 3: Participants aged 6 \< 12 will receive risankizumab based on body weight. Part 4: Participants aged 6 \< 12 will receive risankizumab based on body weight (Japan only: Participants aged 12 \> 18 will receive risankizumab based on body weight). Around 132 participants will be enrolled in approximately 50 sites worldwide. Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection. Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks. Part 2: * Period A: Risankizumab or ustekinumab for 16 weeks. * Period B: Risankizumab or no treatment for 36 weeks. * Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for a study duration of approximately 81 weeks. Participants from each Part who meet eligibility criteria for an open-label extension (OLE) study may continue on risankizumab for 216 additional weeks. There may be a higher burden for study participants compared to standard treatment. Participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
139
Subcutaneous Injection
Subcutaneous Injection
UAB Department of Dermatology /ID# 218834
Birmingham, Alabama, United States
First OC Dermatology /ID# 217733
Fountain Valley, California, United States
Integrative Skin Science and Research /ID# 221741
Sacramento, California, United States
University of California San Diego - Rady Children's Hospital San Diego /ID# 217906
San Diego, California, United States
Rybear, Inc /ID# 223164
Fort Lauderdale, Florida, United States
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.
Time frame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1)
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
Time frame: At Week 16 of initial treatment in each part of the study (Parts 1-4)
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
Time frame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 90% improvement in PASI.
Time frame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 100% improvement in PASI.
Time frame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1)
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
Time frame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
Time frame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 50% improvement in PASI.
Time frame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 50% improvement in PASI.
Time frame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 90% improvement in PASI.
Time frame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 100% improvement in PASI.
Time frame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.
Time frame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL). The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item was scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.
Time frame: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL). The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item was scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.
Time frame: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)
Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score
The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on Quality of Life (QOL) of family members. It consists of 10 questions that assess the impact of skin diseases on different aspects of the family member's QOL. Each item was scored on a 4-point scale: 0 = not at all; 1 = a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.
Time frame: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score
The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on Quality of Life (QOL) of family members. It consists of 10 questions that assess the impact of skin diseases on different aspects of the family member's QOL. Each item was scored on a 4-point scale: 0 = not at all; 1 = a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.
Time frame: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)
Change From Baseline in Itch Numerical Rating Scale (Itch NRS)
The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. A negative change from baseline indicates less intense itching and better outcomes.
Time frame: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
Change From Baseline in Itch Numerical Rating Scale (Itch NRS)
The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. A negative change from baseline indicates less intense itching and better outcomes.
Time frame: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)
Percentage of Participants Achieving >= 4-point Improvement in the Itch Numerical Rating Scale (in Participants With Baseline Score >= 4)
The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch within a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving \>= 4 point improvement in the itch NRS in participants with a baseline itch NRS score of \>=4.
Time frame: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
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Solutions Through Adv Rch /ID# 217936
Jacksonville, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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