NCT07554495招募中3 期
Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib in Children and Adolescents From 8 Years to Less Than 18 Years of Age With Polyarticular-course Juvenile Idiopathic Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 14
- 主要终点
- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation
研究概览
简要总结
This is a multicenter Phase 3, open-label, single-arm study to evaluate the safety, tolerability, PK, and efficacy of orally administered filgotinib for up to 18 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject and/or parent/legal guardian must be able and willing to comply with the clinical study protocol requirements and must sign and date the ICF and assent (if required per local regulation) as approved by the Independent Ethics Committee / Institutional Review Board, prior to any screening evaluations.
- •Female or male subject 8 to <18 years of age, on the date of signing the informed consent and assent (per local regulation) form.
- •Subject must meet the ILAR classification and have moderately to severely active disease for one of the following categories that is not adequately controlled with his/her current therapy (see Protocol Appendix 1 for disease activity assessment criteria):
- •Extended oligoarthritis (i.e. affecting a total of more than 4 joints after the first 6 months of disease)
- •RF-positive polyarthritis
- •RF-negative polyarthritis
- •Subject with intolerance or a history of inadequate response to at least one of the following medications for the treatment of pJIA, administered for at least 3 months, based on current treatment guidelines: conventional synthetic disease modifying anti rheumatic drugs (csDMARDs; including methotrexate) and/or biologic disease modifying anti-rheumatic drugs (bDMARDs) administered per local label, and/or non steroidal anti-inflammatory drugs for ERA and PsA subtypes.
- •Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contraception/preventive exposure measures as described in the protocol.
排除标准
- •Subject with a body weight <15 kg.
- •Subject with persistent oligoarthritis (i.e. affecting not more than 4 joints throughout the disease course).
- •Subject with undifferentiated arthritis.
- •Subject with anterior uveitis (active or uncontrolled) ≤12 weeks prior to baseline.
- •Subject with systemic JIA.
- •Subject with any other rheumatic disease, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, or systemic lupus erythematosus).
- •Subject has any condition or circumstances (including abnormalities in laboratory parameters) that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
- •Subject has an active infection. • Subject with a history of complicated herpes zoster infection (with multi dermatomal, disseminated, ophthalmic, or central nervous system involvement).
研究组 & 干预措施
Filgotinib
Experimental
Filgotinib
干预措施: Filgotinib (Drug)
结局指标
主要结局
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation
时间窗: From baseline (Day 1) the study up to Week 22
次要结局
- Percentage of subjects with juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) 30 response(Week 12 and Week 18)
- Percentage of subjects with JIA ACR inactive disease(Week 12 and Week 18)
- Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 erythrocyte sedimentation rate (ESR)(Week 12 and Week 18)
- Change from baseline in Juvenile Arthritis Disease Activity Score JADAS-27 C-reactive protein (CRP)(Week 12 and Week 18)
- Incidence of uveitis at various timepoints (including occurrence, type, and severity)(Week 1, Week 4, Week 8, Week 12, Week 18)
- PK parameters of filgotinib and its primary metabolite GS-829845 including maximum observed plasma concentration at steady-state [Cmax,ss](Week 4, Week 12 and Week 18)
- PK parameters of filgotinib and its primary metabolite GS-829845 including area under the plasma concentration-time curve over the dosing interval at steady-state [AUC0-24,ss](Week 4, Week 12 and Week 18)
- PK parameters of filgotinib and its primary metabolite GS-829845 including area under the plasma concentration-time curve over the dosing interval at steady-state for the effective exposure [AUCeff,ss](Week 4, Week 12 and Week 18)
- Acceptability of the age-appropriate pediatric formulation and the adult commercially developed film-coated tablet formulation assessed by Pediatric Oral Medicine Acceptability Questionnaire for Patients (POMAQ-P)(Week 4 and Week 18)
研究者
研究点 (14)
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