A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients From 6 to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Risankizumab
* Drug: Ustekinumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Risankizumab Dose A<br>Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks. | Drug: Risankizumab<br>* Subcutaneous Injection<br>* Other names: ABBV-066;|
| Experimental: Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B<br>Participants age 12 to less than 18 will receive: Period A: Ustekinumab Dose A, Dose B, or Dose C based on body weight for 16 weeks (at Week 0 and Week 4). Period B: Risankizumab Dose A or B based on body weight for 24 weeks. | Drug: Risankizumab<br>* Subcutaneous Injection<br>* Other names: ABBV-066;Drug: Ustekinumab<br>* Subcutaneous Injection<br>|
| Experimental: Part 2: Risankizumab Dose A/B<br>Participants age 12 to less than 18 will receive: Period A: Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4). Period B: Participants who respond to Risankizumab in Period A are re-randomized to continue Risankizumab Dose A or B based on body weight for up to 24 weeks or withdraw from treatment until flare. Period C: Participants withdrawn from treatment in Period B and experience a flare in symptoms at Week 28 or beyond are eligible for re-treatment with Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4). | Drug: Risankizumab<br>* Subcutaneous Injection<br>* Other names: ABBV-066;|
| Experimental: Part 3: Risankizumab Dose A/B<br>Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks. | Drug: Risankizumab<br>* Subcutaneous Injection<br>* Other names: ABBV-066;|
| Experimental: Part 4: Risankizumab Dose A/B<br>Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks (Japan only: participants age 12 to less than 18 years will be included). | Drug: Risankizumab<br>* Subcutaneous Injection<br>* Other names: ABBV-066;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 complete erythroderma of the severest degree. | Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4) | 
| Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear | 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). | At Week 16 of each part of the study (Parts 1-4) | 
| US Only: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear 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). | At Week 16 of each part of the study (Parts 1-4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 complete erythroderma of the severest degree. | Baseline (Week 0) to Week 16 of 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 complete erythroderma of the severest degree. | Baseline (Week 0) to Week 16 of 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 complete erythroderma of the severest degree. | Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4) | 
| Part 2 (Period C): Percentage of Participants sPGA Clear or Almost Clear | 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). | Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C) | 
| Part 2 (Period C): US Only: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear 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). | Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C) | 
| 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 complete erythroderma of the severest degree. | Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) | 
| 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 complete erythroderma of the severest degree. | Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) | 
| 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 complete erythroderma of the severest degree. | Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) | 
| 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 complete erythroderma of the severest degree. | Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) | 
| Part 2 (Period A): Change in Children's Dermatology Life Quality Index (CDLQI) | 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). | Baseline (Week 0) to Week 16 in Part 2 (Period A) | 
| Part 2 (Period C): Change in CDLQI | 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 QOL. | Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) | 
| Part 2 (Period A): Change in Family Dermatology Life Quality Index (FDLQI) | 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 QOL of family members. | Baseline (Week 0) to Week 16 in Part 2 (Period A) | 
| Part 2 (Period C): Change in FDLQI | 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 QOL of family members. | Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) | 
| Part 2 (Period C): Change in Itch Numerical Rating Scale (Itch NRS) | The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing no itching and 10, representing worst itch imaginable. | Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) | 
| Part 2 (Period C): Change in Itch NRS | The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing no itching and 10, representing worst itch imaginable. | Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) | 
| Part 2 (Period A): Percentage of Participants Achieving > = 4-point Improvement in the Itch Numerical Rating Scale (in Participants with Baseline Score > = 4) at Each Study Visit | The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing no itching and 10, representing worst itch imaginable. | Baseline (Week 0) to Week 16 in Part 2 (Period A) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ustekinumab, Plaque Psoriasis, Risankizumab, Psoriasis, Biologic, ABBV-066, SKYRIZI