A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 760
- 试验地点
- 201
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs) during the study
研究概览
简要总结
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment
- •The participant completed one of the parent studies within 4 weeks prior to entry to this study
排除标准
- •- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition or ongoing malignancies at the start of the study
研究组 & 干预措施
Dapirolizumab pegol
Subjects will receive dapriolizumab pegol throughout the Treatment Period.
干预措施: Dapirolizumab pegol (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs) during the study
时间窗: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Incidence of serious treatment-emergent adverse events during the study
时间窗: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
A serious treatment-emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
时间窗: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, and leading to permanent drug discontinuation whether or not these events are related to study treatment.
次要结局
- Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24(Week 24)
- Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52(Week 52)
- Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104(Week 104)
- Achievement of LLDAS at ≥50% of all visits(From Baseline (Day 1) until End of Treatment (Week 104))
- Achievement of BICLA response at Week 24(Week 24)
- Achievement of BICLA response at Week 52(Week 52)
- Achievement of BICLA response at Week 104(Week 104)