An Open-label, Multicenter Study to Evaluate Pharmacokinetics, Safety and Tolerability up to 6 Years of Intravenous Secukinumab Infusions in Pediatric Participants With Juvenile Psoriatic Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 11
- 主要终点
- Maximum concentration on Day 1
研究概览
简要总结
The purpose of this study is to determine the PK, safety and tolerability of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA
详细描述
This is a multicenter, open-label study with an optional treatment extension period to evaluate pharmacokinetics, safety and tolerability (up to 6 years) of i.v. secukinumab in pediatric patients with JPsA.
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants parent's or legal representative(s) written informed consent and child's assent, if appropriate, must be obtained before any study related activity or assessment is performed. Of note, if the participant reaches age of consent (as per local law) during the study, they will also need to sign the corresponding study ICF (Informed Consent Form).
- •Males and females ≥2 years old to <18 years old at the time of screening.
- •Confirmed diagnosis of JPsA according to the modified International League of Associations for Rheumatology (ILAR) classification criteria that must have occurred at least 6 months prior to screening.
- •Active JPsA disease defined as ≥3 active joints (swollen or if not swollen must be both tender and limited range of motion) at baseline (BSL).
- •Inadequate response (≥1 month) or intolerance to ≥1 Non-Steroidal Anti-Inflammatory Drug (NSAID) at screening.
- •Inadequate response (≥2 months) or intolerance to ≥ 1 Disease Modifying Anti-Rheumatic Drug (DMARD) at screening.
- •Concomitant use of the following second-line agents such as disease-modifying and/or immunosuppressive drugs to treat the JPsA will be allowed:
- •Stable dose of methotrexate (MTX) (maximum of 20 mg/ m2 BSA/ week) for at least 4 weeks prior to the BSL visit, with folic/folinic acid supplementation (according to standard medical practice of the center).
- •Stable dose of an oral corticosteroid (CS) at a prednisone equivalent dose of <0.2 mg/kg/day or up to 10 mg/day maximum, whichever is less, for at least 7 days prior to BSL.
- •Stable dose of no more than one NSAID for at least 1 week prior to BSL.
排除标准
- •Participants with body weight less than 10 kg at screening.
- •Use of other investigational drugs within 4 weeks or 5 half-lives of BSL, or until the expected pharmacodynamic effect has returned to BSL, whichever is longer.
- •History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes.
- •Participants with active inflammatory bowel disease or active uveitis at screening or BSL.
- •Fulfilling diagnostic criteria for any International League of Associations for Rheumatology (ILAR ) juvenile idiopathic arthritis (JIA) category other than JPsA at BSL.
- •Participants treated with prohibited medication
- •Participants taking any non-biologic DMARD at screening except for MTX.
- •Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
- •Other inclusion/exclusion criteria may apply
研究组 & 干预措施
Secukinumab
Secukinumab administered intravenously in pediatric participants with JPsA
干预措施: Secukinumab (Biological)
结局指标
主要结局
Maximum concentration on Day 1
时间窗: Pre-infusion and end of infusion (EOI) at Day 1
Maximum concentration of secukinumab on Day 1
Maximum concentration at steady-state (Cmax, ss)
时间窗: Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
Maximum concentration at steady-state.
Minimum concentration at steady-state (Cmin, ss)
时间窗: Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
Minimum concentration at steady-state
Area under the concentration-time curve at steady-state (AUCtau, ss)
时间窗: Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
Area under the concentration-time curve at steady-state during a dosing interval
Average concentration at steady-state (Cavg,ss)
时间窗: Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
Average concentration at steady-state
次要结局
- Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 20)
- Number of participants with clinically significant changes in clinical laboratory measures and vital signs.(Up to Week 20)