A Phase 1, Open-label, Multi-center, Multiple-dose Study to Evaluate the Pharmacokinetics of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 12
- 主要终点
- tmax of Telitacicept
研究概览
简要总结
This is a multi-center, open-label, phase 1 study.
详细描述
The purpose of this study is to evaluate the pharmacokinetics (PK) of multiple doses of Telitacicept in subjects with childhood-onset systemic lupus erythematosus (cSLE) on a background of standard of care therapy and explore the safety and efficacy of Telitacicept in patients with cSLE.
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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Fulfills SLICC 2012 or 2019 EULAR/ACR classification criteria for SLE.
- •5-17 years of age when signing the informed consent.
- •Suject and/or legal guardian or parent provided written informed consent.
- •SELENA SLEDAI score ≥ 8 at screening.
- •Serum autoantibodies (ANA and/or anti ds-DNA) tested positive at screening.
- •Have been on a stable standard of care for SLE for at least 30 days prior to randomization.
- •Female patients are required to be non-pregnant, non-lactating or sterile.
排除标准
- •Have received Telitacicept at any time.
- •Have received any of the following therapies within 6 months of baseline: B-cell targeted treatment, e.g., belimumab, rituximab, abatacept, other investigational biologicals.
- •Have received any of the following therapies within 90 days of baseline: anti-TNF or anti-IL-6 therapy, interleukin-1 receptor antagonist, intravenous immunoglobulin (IVIG), plasmapheresis.
- •Have received any of the following therapies within 30 days of baseline: Intravenous cyclophosphamide, non-biological investigational agents (within 30 days of baseline or 5 half-lives, whichever is longer), newly added immunosuppressive/immunomodulatory agent, anti-malarial, NSAID, high-dose prednisone or equivalent (> 1.5 mg/kg/day) or any intramuscular or intravenous steroid.
- •Have received live vaccine within 30 days of baseline.
- •Participated in an interventional clinical trial within 6 months of screening.
- •Active CNS lupus requiring treatment within 60 days of baseline, including seizure, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis or CNS vasculitis.
- •Currently on kidney replacement therapy (hemodialysis, peritoneal dialysis) or in need of such therapy within 90 days of baseline.
- •eGFR<30 mL/min/1.73m
- •Acute severe nephritis.
- •History of vital organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
- •Significant unstable or uncontrolled acute or chronic diseases (cardiovascular, lung, hematology, gastrointestinal, liver, renal, neurologic, malignancy or infectious disease) that could be explained by causes other than SLE.
- •13 Have planned surgery, laboratory abnormalities, other diseases or conditions that, in the opinion of the investigator, makes the subject unsuitable for the study.
- •14. History of malignant neoplasm in the past 5 years.
- •Primary immune deficiency.
- •Acute or chronic infections requiring treatment.
- •HIV or HCV positive.
- •Tuberculosis. 19.HBsAg/HbcAb positive. 20.HBcAb positive. 21.History of COVID-19 within 4 weeks prior to screening. 22.History of hospitalization due to severe Covid-19 within 12 months prior to screening.
- •23.History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
- •24.History of drug or alcohol abuse or dependence within 364 days prior to baseline.
- •25.Investigators believe that there are other factors that are not suitable for participating in the experiment.
研究组 & 干预措施
Telitacicept
The dosing of Telitacicept frequency was based on body weight and age.
干预措施: Telitacicept (Biological)
结局指标
主要结局
tmax of Telitacicept
时间窗: up to 42 days following the last dose of Telitacicept
tmax is defined as time to reach Cmax of Telitacicept
Cmax of Telitacicept
时间窗: up to 42 days following the last dose of Telitacicept
Cmax is defined as peak plasma concentration of Telitacicept
Ctrough of Telitacicept
时间窗: up to 42 days following the last dose of Telitacicept
Ctrough is defined as observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval
Cav of Telitacicept
时间窗: up to 42 days following the last dose of Telitacicept
Average concentration of Telitacicept
AUC0-t of Telitacicept
时间窗: up to 42 days following the last dose of Telitacicept
AUC0-t is defined as area under the curve from time zero to last quantifiable concentration of Telitacicept
t1/2z of Telitacicept
时间窗: up to 42 days following the last dose of Telitacicept
t1/2z is defined as terminal elimination half-life of Telitacicept
λz of Telitacicept
时间窗: up to 42 days following the last dose of Telitacicept
λz is defined as terminal elimination rate constant
次要结局
- Proportion of subjects with SELENA-SLEDAI score reduced from baseline by at least 4 points.(Week 4, Week 8, Week 12)
- SLE Responder Index 4 (SRI 4)(Week 4, Week 8, Week 12)
- Change from baseline in PGA.(Week 4, Week 8, Week 12)
- Change From Baseline in IgG(Week 4, Week 8, Week 12)
- Change From Baseline in IgM(Week 4, Week 8, Week 12)
- Change From Baseline in IgA(Week 4, Week 8, Week 12)
- Change From Baseline in C3(Week 4, Week 8, Week 12)
- Change From Baseline in C4(Week 4, Week 8, Week 12)
- Incidence of AEs(up to Week 12)