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
概览
- 阶段
- 3 期
- 干预措施
- Risankizumab
- 疾病 / 适应症
- Juvenile Psoriatic Arthritis
- 发起方
- AbbVie
- 入组人数
- 40
- 试验地点
- 39
- 主要终点
- Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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.
研究者
入排标准
入选标准
- •Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 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), or 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.
排除标准
- •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 treatments in the anti-TNF or IL-23 inhibitor classes.
研究组 & 干预措施
Risankizumab
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.
干预措施: Risankizumab
Adalimumab
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.
干预措施: Adalimumab
结局指标
主要结局
Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)
时间窗: Up to 24 Weeks
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).
Number of Participants with Adverse Events (AEs)
时间窗: Up to Week 144
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
- Percentage of Participants with Inactive Disease(Week 24)
- Change from Baseline in the Pain-Visual Analogue Scale (VAS)(Week 24)
- Percentage of Participants who Achieve >= 50% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 50)(Up to 24 Weeks)
- Percentage of Participants who Achieve >= 70% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 70)(Up to 24 Weeks)
- Percentage of Participants who Achieve >= 90% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 90)(Up to 24 Weeks)
- Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10(Up to Week 24)
- Percentage of Participants with Achievement of Minimal Disease Activity (MDA)(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(Up to Week 24)
- Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10(Up to Week 24)
- Change from Baseline in cJADAS-27(Up to 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(Up to Week 24)
- Change from Baseline in JADAS-27(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(Up to Week 24)
- Percentage of Participants with PsO who Achieve PASI 90 in Participants with at least 3% BSA at Baseline(Up to Week 24)