Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 101
- 试验地点
- 43
- 主要终点
- Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period)
研究概览
简要总结
The reason for this study is to see if the study drug ixekizumab is safe and effective in children with juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) (including juvenile onset ankylosing spondylitis [JoAS]) and juvenile psoriatic arthritis (JPsA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have active juvenile idiopathic arthritis (categories of enthesitis related arthritis or juvenile psoriatic arthritis)
- •Participants must have weight of at least 10 kilograms (Kg), age starting at 2 years for participants with juvenile psoriatic arthritis and starting at 6 years for participants with enthesitis related arthritis
- •Participants must have all immunizations up-to-date in agreement with current immunization guidelines, in the opinion of the investigator
排除标准
- •Participants must not have active or history of inflammatory bowel disease
- •Participants must not have active uveitis
- •Participants must not have active or latent tuberculosis
- •Participants must not have an active infection
- •Participants must not have concurrent use of biologic agents for the treatment of the juvenile idiopathic arthritis
研究组 & 干预措施
Ixekizumab - OLT Period
Participants received subcutaneous (SC) ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
- Greater than (>) 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC every 4 weeks (Q4W) from week 2 to week 16.
- 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
- 10.0 to less than (<) 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
干预措施: Ixekizumab (Drug)
Adalimumab - OLT Period
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
- Greater than or equal to (≥) 30.0 kg: 40 mg SC every 2 weeks (Q2W).
- 10.0 to <30.0 kg: 20 mg SC Q2W.
干预措施: Adalimumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period)
时间窗: Week 16
JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.
次要结局
- Percentage of Participants Achieving JIA ACR 30 (Adalimumab - OLT Period)(Week 16)
- Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period)(Week 16)
- Percentage of Participants Achieving JIA ACR 30/50/70/90/100 (OLE Period)(Week 104)
- Change From Baseline in Psoriasis Area and Severity Index (PASI) for Juvenile Psoriatic Arthritis (JPsA) Participants With at Least 3% Body Surface Area (BSA) at Baseline (OLT Period)(Baseline, Week 16)
- Change From Baseline in Psoriasis Area and Severity Index (PASI) for Juvenile Psoriatic Arthritis (JPsA) Participants With at Least 3% Body Surface Area (BSA) at Baseline (OLE Period)(Baseline, Week 104)
- Change From Baseline in Leeds Enthesitis Index (LEI) for Participants With Enthesitis Related Arthritis (ERA) at Baseline (OLT Period)(Baseline, Week 16)
- Change From Baseline in Leeds Enthesitis Index (LEI) for Participants With Enthesitis Related Arthritis (ERA) at Baseline (OLE Period)(Baseline, Week 104)
- Percentage of Participants With Disease Flare (OLT Period)(Week 2 through Week 16)
- Percentage of Participants With Disease Flare (OLE Period)(Baseline through Week 104)
- Pharmacokinetics (PK): Trough Concentrations (C-trough) of Ixekizumab (Ixekizumab - OLT Period)(Week 4, 12 and 16 : Pre-dose)
- Pharmacokinetics (PK): Trough Concentrations (C-trough) of Ixekizumab (Ixekizumab - OLE Period)(Week 20, 32, 56, 80 and 104 : Pre-dose)
- Percentage of Participants With Treatment-emergent Positive Anti-ixekizumab Antibodies (Ixekizumab - OLT Period)(Baseline through Week 16)
- Percentage of Participants With Treatment-emergent Positive Anti-ixekizumab Antibodies (Ixekizumab - OLE Period)(Baseline through Week 104)