NCT05925452尚未招募2 期
A Multicenter, Randomized, Open-label Phase IIb Clinical Study to Evaluate the Efficacy and Safety of GenaKumab in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period
研究概览
简要总结
A multicenter, randomized, open-label Phase IIb clinical study to evaluate the efficacy and safety of GenaKumab in the treatment of active systemic juvenile idiopathic arthritis.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, with the remaining before age 2 years old or more and & lt; 18 years old;
- •2001 ILAR classification criteria for the diagnosis of confirmed sJIA 2 or more months: onset age must & lt; At 16 years of age, symptoms included: ≥1 case of arthritis, accompanied by or prior to ≥2 weeks of recurrent fever, including remittenor fever for ≥3 consecutive days (maximum daily body temperature ≥39 ° C, body temperature falling below 37 ° C between 2 heat peaks), accompanied by at least one of the following symptoms: ① a transient, non-fixed erythematous rash; ② systemic lymph node enlargement; Swelling of the liver and/or spleen; ④ Serositis.
- •Agree to use effective means of contraception throughout the study period and for 6 months after the end of treatment.
排除标准
- •Pregnant or lactating female subjects
- •A history of allergic reactions to investigational drugs or to molecules with similar structures; Those who cannot be given intramuscular injections；
- •History of pericarditis, myocarditis, serositis, bacterial heart valve or endocarditis within 6 months before screening; Patients who had been diagnosed with MAS within 6 months prior to screening, or had relevant symptoms and signs at screening, and were suspected of having MAS as assessed by the investigators；
- •There are other rheumatic diseases such as Kawasaki disease, polyarteritis nodosa and so on. History of autoinflammatory diseases such as familial Mediterranean fever, high IgD syndrome, NLRP3-related autoinflammatory diseases；
- •Patients with a history of interstitial lung disease, pulmonary fibrosis, alveolar proteinosis, or pulmonary hypertension; Patients with a history of repeated invasive fungal infection; In the 7 days prior to randomization, there were infections that required control with systemic antigenic microbiotics (including antibacterial, antiviral, antifungal, etc.)；
- •Subjects with a history of TB exposure or suspected TB symptoms.
研究组 & 干预措施
GenaKumab
Experimental
15 subjects: GenaKumab 3.0mg/kg dose group and 4.0 mg/kg dose group, Subcutaneous injection, Q4w
干预措施: GenaKumab (Drug)
结局指标
主要结局
Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period
时间窗: 24 Week
次要结局
未报告次要终点
研究者
研究点 (10)
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