An Open-label, Multiple Dose, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Filgotinib in Children and Adolescents From 8 to Less Than 18 Years of Age With Juvenile Idiopathic Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 19
- 主要终点
- Cmax,ss of GS-829845, major active metabolite
研究概览
简要总结
A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant with a body mass index (BMI) within the 5th to 95th percentiles for the age and gender (based on World Health Organization BMI charts). Participant must have a minimum weight of 15 kg.
- •Participant must meet the International League of Associations for Rheumatology classification for 1 of the following categories and have, according to the investigator's judgment, moderately to severely active disease that is not adequately controlled with his/her current therapy.
- •Rheumatoid factor (RF)-positive polyarthritis
- •RF-negative polyarthritis
- •Oligoarthritis
- •Psoriatic arthritis
- •Enthesis-related arthritis (ERA) Note: Historical Human leukocyte antigen B-27 (HLA-B27) results are considered appropriate for ERA diagnosis during screening.
- •Systemic JIA with active arthritis without active systemic features, or with active systemic features that are stable in the prior 6 months of time of enrollment
- •Participant with intolerance or a history of inadequate response to at least one of the following medications for the treatment of JIA, administered for at least 12 weeks, based on current treatment guidelines: conventional synthetic disease-modifying antirheumatic drugs and biological disease-modifying antirheumatic drugs (including methotrexate) and non-steroidal anti-inflammatory drugs for ERA and psoriatic arthritis.
- •Female participants of childbearing potential (i.e. who have passed menarche) must have a negative highly sensitive urine pregnancy test.
排除标准
- •Participant with persistent oligoarthritis.
- •Participant with undifferentiated arthritis.
- •Participant with any other any other rheumatic, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, systemic lupus erythematosus, or uncontrolled uveitis).
- •Active infection that is clinically significant, as per judgment of the investigator.
- •Participant with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement).
- •Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, or atypical mycobacteria).
- •Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Filgotinib Dose B
Dose B of filgotinib tablet for participants with BW ≥25-<60 kg
干预措施: Filgotinib (Drug)
Filgotinib Dose C
Dose C of filgotinib tablet for participants with BW ≥60 kg
干预措施: Filgotinib (Drug)
Filgotinib Dose A
Dose A of filgotinib mini-tablet for participants with bodyweight (BW) 15-<25 kg
干预措施: Filgotinib (Drug)
结局指标
主要结局
Cmax,ss of GS-829845, major active metabolite
时间窗: Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Area under the plasma concentration-time curve over the dosing interval at steady state of filgotinib (AUC0-24,ss)
时间窗: Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Maximum observed plasma concentration at steady state of filgotinib (Cmax,ss)
时间窗: Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
AUC0-24,ss of GS-829845, major active metabolite
时间窗: Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Area under the plasma concentration time curve over the dosing interval at steady state or the effective exposure of filgotinib (AUCeff,ss)
时间窗: Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
AUCeff,ss of GS-829845, major active metabolite
时间窗: Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
次要结局
- Number of participants with treatment-emergent adverse events (TEAEs), TEAEs of interest, serious TEAEs, and TEAEs leading to treatment discontinuation.(Baseline (Day 1) up to week 96)
- Acceptability of the commercially developed film-coated tablets and of the minitablets as measured by the Pediatric Oral Medicine Acceptability Questionnaire for Patients (POMAQ-P).(Week 4 and week 12)