A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

Study Overview
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Brief Summary
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Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms. Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide. Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Official Title
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Open-label, Randomized, Assessor-blinded, Efficacy, Safety, Tolerability, and Pharmacokinetics Study of Subcutaneous Risankizumab With an Adalimumab Reference Arm in Children With Active Juvenile Psoriatic Arthritis

Conditions
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Juvenile Psoriatic Arthritis

Intervention / Treatment
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* Drug: Adalimumab
* Drug: Risankizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 6 months prior to screening. Active Disease in >= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both) are eligible for inclusion in the study. Have had an inadequate response (lack of efficacy after minimum 2-month duration of therapy at maximally tolerated dose). Intolerance to previous or current treatment with at least 1 of the following conventional synthetic disease-modifying antirheumatic drug (csDMARDs): methotrexate (MTX), sulfasalazine, leflunomide, or hydroxychloroquine. Exclusion Criteria: Have any other autoimmune disease, rheumatic disease (including systemic Juvenile idiopathic arthritis [JIA], rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, persistent oligoarticular JIA, enthesitis-related arthritis, and undifferentiated JIA), or overlap syndrome. Prior inadequate response to drugs in the anti-TNF, IL-23 inhibitor, and IL-12/23 inhibitor classes.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risankizumab<br>Participants will receive risankizumab for 24 weeks, in Period 1. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. There will be a 140 day safety follow up after the treatment period. | Drug: Risankizumab<br>* Subcutaneous (SC) Injection<br>* Other names: Skyrizi;|
| Experimental: Adalimumab<br>Participants will receive adalimumab for 24 weeks, in Period 1. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. There will be a 70 day safety follow up after the treatment period. | Drug: Adalimumab<br>* SC Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30) | The JIA-ACR 30 response is defined as a >= 30% improvement of at least 3 or more of the 6 juvenile idiopathic arthritis core response variables (JIA-CRVs) without >30% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: physician global assessment of disease activity (PhGA), global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion high sensitivity C-reactive protein (hsCRP), and functional ability assessed by Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI). | Up to 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who Achieve >= 50% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 50) | The JIA-ACR 50 response is defined as a >= 50% improvement of at least 3 or more of the 6 JIA-CRVs without >50% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI. | Up to 24 Weeks | 
| Percentage of Participants who Achieve >= 70% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 70) | The JIA-ACR 70 response is defined as a >= 70% improvement of at least 3 or more of the 6 JIA-CRVs without >70% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI. | Up to 24 Weeks | 
| Percentage of Participants who Achieve >= 90% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 90) | The JIA-ACR 90 response is defined as a >= 90% improvement of at least 3 or more of the 6 JIA-CRVs without >90% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI. | Up to 24 Weeks | 
| Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10 | JADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both), and high sensitivity C-reactive protein (hsCRP). JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints. | Up to Week 24 | 
| Change from Baseline in JADAS-27 | JADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both), and hsCRP. JADAS-27 includes a count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), and proximal interphalangeal joints, hips, knees, and ankles. | Up to Week 24 | 
| Percentage of Participants with Achievement of Minimal Disease Activity (MDA) | MDA is defined as JADAS-10 of <= 6. JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints. | Week 24 | 
| Percentage of Participants with Inactive Disease | Inactive disease is defined as JADAS-10 of <= 2.7. JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints. | Week 24 | 
| Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10 | cJADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, and number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both). JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints. | Up to Week 24 | 
| Change from Baseline in cJADAS-27 | cJADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, and number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both). JADAS-27 includes a count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), and proximal interphalangeal joints, hips, knees, and ankles. | Up to Week 24 | 
| Change from Baseline in the Pain-Visual Analogue Scale (VAS) | Participants assessed their pain using a Patient's Global Assessment Pain visual analogue scale (VAS). The range is 0 to 100 with no pain being indicated by 0 and severe pain by 100. | Week 24 | 
| Percentage of Participants with Psoriasis (PsO) who Achieve Psoriasis Area Severity Index (PASI) 75 in Participants with at least 3% Body Surface Area (BSA) at Baseline | The PASI is a measure of psoriasis severity. Four anatomic sites - head, upper extremities, trunk, and lower extremities - are assessed for erythema, induration and desquamation using a 5-point scale, with a lower score indicating more mild disease. | Up to Week 24 | 
| Percentage of Participants with PsO who Achieve PASI 90 in Participants with at least 3% BSA at Baseline | The PASI is a measure of psoriasis severity. Four anatomic sites - head, upper extremities, trunk, and lower extremities - are assessed for erythema, induration and desquamation using a 5-point scale, with a lower score indicating more mild disease. | Up to Week 24 | 
| Percentage of Participants with PsO who Achieve Static Physician Global Assessment of Disease Activity (sPGA) of PsO of 'Clear' (0) or Almost Clear (1) in Participants with at least 3% BSA at Baseline | The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions, with a lower score indicating less body coverage. | Up to Week 24 | 
| Percentage of Participants with PsO who Achieve change from Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants with at least 3% BSA at Baseline | The CDLQI is a 10-item questionnaire used to assess the impact of dermatologic disease symptoms and treatment on quality-of-life (QOL), with a higher score indicating greater impairment of QOL. The CDLQI has been validated for use in participants 4 to 16 years old. | Up to Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Juvenile Psoriatic Arthritis, Psoriatic Arthritis, Risankizumab, ABBV-066, Adalimumab