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
Overview
- Phase
- Phase 3
- Intervention
- Risankizumab
- Conditions
- Psoriasis
- Sponsor
- AbbVie
- Enrollment
- 139
- Locations
- 53
- Primary Endpoint
- Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Part 1: Risankizumab Dose A
Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks.
Intervention: Risankizumab
Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
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.
Intervention: Risankizumab
Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
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.
Intervention: Ustekinumab
Part 2: Risankizumab Dose A/B
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).
Intervention: Risankizumab
Part 3: Risankizumab Dose A/B
Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.
Intervention: Risankizumab
Part 4: Risankizumab Dose A/B
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).
Intervention: Risankizumab
Outcomes
Primary Outcomes
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)
Time Frame: 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)
Time Frame: 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
Time Frame: 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 Outcomes
- Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)(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)(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 (0 or 1)(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(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)(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)(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(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(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)(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)(Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A))