NCT02991469招募中2 期
An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, With Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 51
- 试验地点
- 60
- 主要终点
- Assessment of PK parameter: maximum serum concentration observed (Cmax)
研究概览
简要总结
Primary Objective:
To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for adequate treatment of this population.
Secondary Objective:
To describe the pharmacodynamics (PD) profile, the efficacy, and the long term safety of sarilumab in patients with sJIA.
详细描述
The total study duration per patient will be 166 weeks that will consist of a 4- week screening, a 12-week core treatment phase, a 144-week extension phase, and a 6-week post-treatment follow-up.
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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥1 and ≤17 years (or country specified age requirement, ≥6 to ≤17 years for Russia) at the time of the screening visit.
- •Diagnosis of systemic JIA subtype according to the International Associations against Rheumatism (ILAR) 2001 Juvenile Idiopathic Arthritis (JIA) Classification Criteria OR According to 2024 EULAR/PReS recommendation at Screening.
- •Patient with an inadequate response to current treatment and considered as a candidate for a biologic disease modifying anti rheumatic drug (DMARD) as per investigator's judgment.
排除标准
- •Body weight <10 kg or >60 kg for patients enrolled in the ascending dose cohorts, then body weight <10 kg for patients subsequently enrolled at the selected dose.
- •Uncontrolled severe systemic symptoms and/or Macrophage Activation Syndrome (MAS) within 6 months prior to screening.
- •History of or ongoing interstitial lung disease, pulmonary hypertension, pulmonary alveolar proteinosis.
- •If nonsteroidal anti-inflammatory drugs (NSAIDs) (including cyclo oxygenase-2 inhibitors [COX-2]) taken, dose stable for less than 2 weeks prior to the baseline visit and/or dosing prescribed outside of approved label.
- •If non-biologic DMARD taken, dose stable for less than 6 weeks prior to the baseline visit or at a dose exceeding the recommended dose as per local labeling.
- •If oral glucocorticoid taken, dose exceeding equivalent prednisone dose 1 mg/kg/day (or 60 mg/day) within 3 days prior to baseline.
- •Use of parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline.
- •Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.
- •Treatment with any biologic treatment for sJIA within 5 half-lives prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).
- •Treatment with a Janus kinase inhibitor within 4 weeks prior to the first dose of sarilumab; and treatment with growth hormone within 4 weeks prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).
- •Treatment with any investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline, whichever is longer.
- •Exclusion related to tuberculosis.
- •Exclusion criteria related to past or current infection other than tuberculosis.
- •Any live, attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, rubella vaccines. Killed or inactive vaccine may be permitted based on the Investigator's judgment.
- •Exclusion related to history of a systemic hypersensitivity reaction to any biologic drug and known hypersensitivity to any constituent of the product.
- •Laboratory abnormalities at the screening visit (identified by the central laboratory).
- •Severe cardiac disease due to sJIA.
- •Pregnant or breast-feeding female adolescent patients.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Sarilumab
Experimental
Participants will receive one of two ascending doses (or an additional intermediate dose based on available data) of sarilumab by subcutaneous (SC) injection based on body weight. All the participants will receive the selected dose once the selected dose is identified. Sarilumab will be given during 12-week core treatment phase followed by a 144- week extension treatment phase.
干预措施: Sarilumab SAR153191 (REGN88) (Drug)
结局指标
主要结局
Assessment of PK parameter: maximum serum concentration observed (Cmax)
时间窗: Up to Week 12
Assessment of PK parameter: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t)
时间窗: Up to Week 12
Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)
时间窗: Up to Week 12
次要结局
- Number of patients with adverse events(Core treatment phase: Up to Week 12. Extension phase: Up to Week 162)
- Proportion of participants with local reactions after injection(Core treatment phase: Up to Week 12. Extension phase: Up to Week 156)
- Proportion of participants with Investigator Global Assessment (IGA) of disease activity below a defined value on 1-100 VAS scale(Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156)
- Proportion of participants with Parent / patient Global Assessment (PGA) of well-being below a defined value on 1-100 VAS scale(Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156)
- Proportion of participants with clinically inactive disease (CID)(Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156)
- Changes in glucocorticoid use(Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156)
- Juvenile Idiopathic Arthritis ACR30/50/70/90/100 (in the absence of fever) response rate(Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156)
- Change from baseline in individual JIA ACR components(Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156)
- Change from baseline in Systemic Juvenile Arthritis Disease Activity Score-10 (sJADAS-10)(Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156)
- Assessment of participants with disease-related symptoms(At Week 4)
- Changes in IL-6 associated biomarkers(Up to Week 12)
研究者
研究点 (60)
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