Psoriasis
Conditions
Keywords
Plaque Psoriasis, Risankizumab, Ustekinumab, Psoriasis, Biologic, ABBV-066, SKYRIZI
Brief summary
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.
Interventions
DRUGRisankizumab
Subcutaneous Injection
DRUGUstekinumab
Subcutaneous Injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit. * Stable severe or moderate to severe plaque psoriasis as defined in each study part by body surface area (BSA) psoriasis involvement and scores on the Psoriasis Area and Severity Index (PASI) and Static Physician Global Assessment (sPGA). * Candidate for systemic therapy as assessed by the investigator and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol.
Exclusion criteria
\- Concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI) | Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4) | 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. |
| Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) | At Week 16 of initial treatment in each part of the study (Parts 1-4) | 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). |
| 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 | Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C) | 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). |
| Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI) | Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4) | 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. |
| Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI) | Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C) | 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. |
| Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI) | Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4) | 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. |
| Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score | Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A) | 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. |
| Change From Baseline in Itch Numerical Rating Scale (Itch NRS) | Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A) | 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. |
| Percentage of Participants Achieving >= 4-point Improvement in the Itch Numerical Rating Scale (in Participants With Baseline Score >= 4) | Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A) | 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. |
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A) | 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. |
| Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI) | Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4) | 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. |
| Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1) | Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C) | 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). |
Countries
Canada, Germany, Japan, Poland, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 139 participants were sequentially enrolled in the trial. Two participants in Part 4 were excluded from the Intent To Treat (ITT) Population because they were not from the same age cohort as the population studied in Part 4 (children) but were added to Part 4 for administrative reasons (closure of Part 2 enrollment).
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Risankizumab Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40. | 12 |
| Part 2 Period A: Ustekinumab Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4. | 28 |
| Part 2 Period A: Risankizumab Participants received risankizumab by subcutaneous injection at Weeks 0 and 4. | 54 |
| Part 3: Risankizumab Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40. | 13 |
| Part 4: Risankizumab Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40. | 30 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 2: Period A (Baseline to Week 16) | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 4 (Baseline to Week 52) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Part 4 (Baseline to Week 52) | Other than specified | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Part 4 (Baseline to Week 52) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Part 1: Risankizumab | Total | Part 4: Risankizumab | Part 3: Risankizumab | Part 2 Period A: Risankizumab | Part 2 Period A: Ustekinumab |
|---|---|---|---|---|---|---|
| Age, Customized 12 to <15 years | 5 Participants | 41 Participants | 0 Participants | 0 Participants | 22 Participants | 14 Participants |
| Age, Customized 15 to <18 years | 7 Participants | 53 Participants | 0 Participants | 0 Participants | 32 Participants | 14 Participants |
| Age, Customized 6 to < 9 years | 0 Participants | 13 Participants | 10 Participants | 3 Participants | 0 Participants | 0 Participants |
| Age, Customized 9 to < 12 years | 0 Participants | 30 Participants | 20 Participants | 10 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 17 Participants | 0 Participants | 1 Participants | 8 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 120 Participants | 30 Participants | 12 Participants | 46 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Psoriasis Area and Severity Index (PASI) Score | 21.43 score on a scale STANDARD_DEVIATION 8.124 | 18.28 score on a scale STANDARD_DEVIATION 7.716 | 18.59 score on a scale STANDARD_DEVIATION 9.211 | 26.21 score on a scale STANDARD_DEVIATION 9.158 | 16.39 score on a scale STANDARD_DEVIATION 4.909 | 16.55 score on a scale STANDARD_DEVIATION 7.229 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 19 Participants | 7 Participants | 3 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 8 Participants | 2 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 104 Participants | 20 Participants | 10 Participants | 48 Participants | 20 Participants |
| Sex: Female, Male Female | 7 Participants | 80 Participants | 18 Participants | 9 Participants | 31 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 57 Participants | 12 Participants | 4 Participants | 23 Participants | 13 Participants |
| Static Physician Global Assessment (sPGA) Category 0 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Static Physician Global Assessment (sPGA) Category 1 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Static Physician Global Assessment (sPGA) Category 2 | 0 Participants | 11 Participants | 3 Participants | 0 Participants | 6 Participants | 2 Participants |
| Static Physician Global Assessment (sPGA) Category 3 | 0 Participants | 92 Participants | 23 Participants | 2 Participants | 42 Participants | 25 Participants |
| Static Physician Global Assessment (sPGA) Category 4 | 12 Participants | 34 Participants | 4 Participants | 11 Participants | 6 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 54 | 0 / 28 | 0 / 28 | 0 / 10 | 0 / 22 | 0 / 21 | 0 / 8 | 0 / 13 | 0 / 32 |
| other Total, other adverse events | 6 / 12 | 21 / 54 | 11 / 28 | 19 / 28 | 8 / 10 | 13 / 22 | 11 / 21 | 4 / 8 | 6 / 13 | 23 / 32 |
| serious Total, serious adverse events | 0 / 12 | 0 / 54 | 0 / 28 | 1 / 28 | 1 / 10 | 0 / 22 | 1 / 21 | 0 / 8 | 0 / 13 | 0 / 32 |
Outcome results
Primary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Risankizumab | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI) | 83.3 percentage of participants |
| Part 2 Period A: Ustekinumab | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI) | 85.7 percentage of participants |
| Part 2 Period A: Risankizumab | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI) | 85.2 percentage of participants |
| Part 3: Risankizumab | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI) | 92.3 percentage of participants |
| Part 4: Risankizumab | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI) | 86.7 percentage of participants |
Primary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Risankizumab | Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) | 83.3 percentage of participants |
| Part 2 Period A: Ustekinumab | Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) | 75.0 percentage of participants |
| Part 2 Period A: Risankizumab | Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) | 79.6 percentage of participants |
| Part 3: Risankizumab | Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) | 84.6 percentage of participants |
| Part 4: Risankizumab | Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) | 90.0 percentage of participants |
Primary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Risankizumab | 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 | 83.3 percentage of participants |
| Part 2 Period A: Ustekinumab | 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 | 67.9 percentage of participants |
| Part 2 Period A: Risankizumab | 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 | 68.5 percentage of participants |
| Part 3: Risankizumab | 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 | 84.6 percentage of participants |
| Part 4: Risankizumab | 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 | 83.3 percentage of participants |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period A only.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Risankizumab | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | -6.8 score on a scale | Standard Error 0.66 |
| Part 2 Period A: Ustekinumab | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | -7.4 score on a scale | Standard Error 0.49 |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period C only.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Risankizumab | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | -7.5 score on a scale | Standard Error 2.88 |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period C only.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Risankizumab | Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score | -5.8 score on a scale | Standard Error 3.29 |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period A only.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Risankizumab | Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score | -6.0 score on a scale | Standard Error 0.84 |
| Part 2 Period A: Ustekinumab | Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score | -6.9 score on a scale | Standard Error 0.6 |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period A only.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Risankizumab | Change From Baseline in Itch Numerical Rating Scale (Itch NRS) | -2.9 score on a scale | Standard Error 0.5 |
| Part 2 Period A: Ustekinumab | Change From Baseline in Itch Numerical Rating Scale (Itch NRS) | -3.8 score on a scale | Standard Error 0.38 |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period C only.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Risankizumab | Change From Baseline in Itch Numerical Rating Scale (Itch NRS) | -2.8 score on a scale | Standard Error 1.68 |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period A only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Risankizumab | Percentage of Participants Achieving >= 4-point Improvement in the Itch Numerical Rating Scale (in Participants With Baseline Score >= 4) | 57.1 percentage of participants |
| Part 2 Period A: Ustekinumab | Percentage of Participants Achieving >= 4-point Improvement in the Itch Numerical Rating Scale (in Participants With Baseline Score >= 4) | 64.9 percentage of participants |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period C only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Risankizumab | Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI) | Baseline (Week 0) | 0 percentage of participants |
| Part 1: Risankizumab | Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI) | Week 16 | 25.0 percentage of participants |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Risankizumab | Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI) | 41.7 percentage of participants |
| Part 2 Period A: Ustekinumab | Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI) | 17.9 percentage of participants |
| Part 2 Period A: Risankizumab | Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI) | 40.7 percentage of participants |
| Part 3: Risankizumab | Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI) | 53.8 percentage of participants |
| Part 4: Risankizumab | Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI) | 43.3 percentage of participants |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Risankizumab | Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI) | 91.7 percentage of participants |
| Part 2 Period A: Ustekinumab | Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI) | 92.9 percentage of participants |
| Part 2 Period A: Risankizumab | Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI) | 90.7 percentage of participants |
| Part 3: Risankizumab | Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI) | 100 percentage of participants |
| Part 4: Risankizumab | Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI) | 96.7 percentage of participants |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period C only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Risankizumab | Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI) | Baseline (Week 0) | 75.0 percentage of participants |
| Part 1: Risankizumab | Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI) | Week 16 | 87.5 percentage of participants |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period C only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Risankizumab | Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI) | Baseline (Week 0) | 37.5 percentage of participants |
| Part 1: Risankizumab | Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI) | Week 16 | 87.5 percentage of participants |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period C only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Risankizumab | Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI) | Baseline (Week 0) | 37.5 percentage of participants |
| Part 1: Risankizumab | Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI) | Week 16 | 87.5 percentage of participants |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Risankizumab | Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI) | 83.3 percentage of participants |
| Part 2 Period A: Ustekinumab | Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI) | 60.7 percentage of participants |
| Part 2 Period A: Risankizumab | Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI) | 64.8 percentage of participants |
| Part 3: Risankizumab | Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI) | 84.6 percentage of participants |
| Part 4: Risankizumab | Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI) | 76.7 percentage of participants |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period C only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Risankizumab | Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1) | Baseline (Week 0) | 12.5 percentage of participants |
| Part 1: Risankizumab | Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1) | Week 16 | 62.5 percentage of participants |
Secondary
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)
Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure in Part 2 Period C only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Risankizumab | 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 | Baseline (Week 0) | 0.0 percentage of participants |
| Part 1: Risankizumab | 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 | Week 16 | 62.5 percentage of participants |