A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 53
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 and BN40900. Participants will receive satralizumab as monotherapy or in combination with one of the following background immunosuppressive treatments: azathioprine (AZA), mycophenolate mofetil (MMF), or oral corticosteroids.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged less than 18 years at the time of informed consent for Study BN40898 can continue treatment with a combination of oral corticosteroids and either AZA or MMF
- •Participated in Study BN40898 or Study BN40900 with satralizumab in NMOSD, are on ongoing satralizumab treatment and were anti-aquaporin-4 IgG antibody (AQP4-IgG) seropositive at screening in these studies. Participants with NMOSD who were AQP4-IgG seronegative at screening in Study BN40898 or Study BN40900 can be enrolled if the investigator considers the continued treatment with satralizumab to be beneficial for the participant
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 3 months after the final dose of satralizumab.
排除标准
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug. Women of childbearing potential must have a negative urine pregnancy test result on the baseline visit prior to initiation of study drug
- •Evidence of any serious uncontrolled concomitant diseases that may preclude participation including nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency
- •Known active infection that requires delaying the next satralizumab dose at the time of enrollment
- •NMOSD relapse at the time of enrollment
- •Laboratory abnormalities at the last assessment in Study BN40898 or Study BN40900 that preclude re-treatment with satralizumab
研究组 & 干预措施
Satralizumab Treatment
Participants will receive satralizumab subcutaneously (SC) every 4 weeks (Q4W)
干预措施: satralizumab (Drug)
Satralizumab Treatment
Participants will receive satralizumab subcutaneously (SC) every 4 weeks (Q4W)
干预措施: azathioprine (AZA) (Drug)
Satralizumab Treatment
Participants will receive satralizumab subcutaneously (SC) every 4 weeks (Q4W)
干预措施: mycophenolate mofetil (MMF) (Drug)
Satralizumab Treatment
Participants will receive satralizumab subcutaneously (SC) every 4 weeks (Q4W)
干预措施: oral corticosteroids (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 523 weeks
AE=any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with it. AE can therefore be any unfavorable \& unintended sign, symptoms/disease temporally associated with use of a medicinal (investigational) product, whether or not considered related to it. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All AEs from the time of randomization in the parent studies for satralizumab-treated participants are reported here.
Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs
时间窗: Baseline up to 523 weeks
An AESIs included potential drug induced liver injury and suspected transmission of an infectious agent by study drug defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic causing clinical symptoms or laboratory findings that indicate an infection in a participant exposed to a medicinal product. Selected AEs included infections that required treatments with IV antibiotics, antifungals, or antivirals; opportunistic infections that required treatment with oral antibiotics, antifungals, or antivirals and injection related reaction. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All AEs from the time of randomization in the parent studies for satralizumab-treated participants are reported here.
次要结局
- Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline up to 523 weeks)
- Number of Participants With Serious Infections and Hepatotoxicity(Baseline up to 523 weeks)
- Time to First Protocol-defined Relapse (PDR) as Assessed by Investigator (iPDR)(Baseline up to 528 weeks)
- iPDR-free Rate up to Week 456(Baseline up to Week 456)
- Percentage of Relapse-Free Participants(Baseline up to 528 weeks)
- Annualized Relapse Rate (ARR)(Baseline up to 528 weeks)
- Change in Expanded Disability Status Scale (EDSS) Score(Baseline and every 24 weeks (up to 528 weeks))
- Time to First EDSS Scores Worsening(Baseline up to 528 weeks)
- Event-free Rate for EDSS Score Worsening up to Week 456(Baseline up to Week 456)
- Percentage of Participants Without EDSS Worsening(Baseline up to 528 weeks)
- Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart(Baseline and every 24 weeks (up to 528 weeks))
- Concentrations of Interleukin-6 (IL-6) in Blood(Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528)
- Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood(Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528)
- Concentration of C-Reactive Protein (CRP) in Blood(Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528)
- Serum Concentration of Satralizumab at Specified Timepoints(Baseline, Week 2, Week 4, Week 5, Week 6; every 4 weeks from Weeks 8 to 192; every 24 weeks from Weeks 216 to 528)
- Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279(First dose of satralizumab in parent studies up to end of study WN42349 (up to 523 weeks))