A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB12 (Proposed Eculizumab Biosimilar) and Soliris® in Subjects With Paroxysmal Nocturnal Haemoglobinuria
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 27
- 主要终点
- Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52
研究概览
简要总结
This is a randomised Phase III, double-blind, multicentre, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and Soliris® in subjects with PNH.
详细描述
Subjects will be randomised in a 1:1 ratio to either treatment sequence. Subjects randomly assigned to treatment with SB12 or Soliris® will receive 600 mg of eculizumab IV every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks until Week 52. Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® and subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female aged 18 or older
- •Eculizumab-naïve patients with PNH
- •Presence of the PNH white blood cell (WBC) clone ≥ 10%
- •Documented LDH level ≥ 1.5 x ULN at Screening
- •History of transfusion for anaemia within 12 months prior to Screening or having PNH-related symptoms at Screening
- •Subjects must be vaccinated against Neisseria meningitides
排除标准
- •Previous treatment with any complement pathway inhibitors
- •ANC ≤ 500/mm3 or Platelet count < 70,000/mm3
- •History of meningococcal disease
- •History of bone marrow transplantation
- •Known or suspected active bacterial/viral/fungal infection within 30 days
- •Stable use of erythropoietic, corticosteroids, heparin, warfarin before randomisation
研究组 & 干预措施
Treatment Sequence I
Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® at Week 26
干预措施: SB12 (proposed eculizumab biosimilar) (Drug)
Treatment Sequence I
Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® at Week 26
干预措施: Soliris (eculizumab) (Drug)
Treatment Sequence II
Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26
干预措施: SB12 (proposed eculizumab biosimilar) (Drug)
Treatment Sequence II
Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26
干预措施: Soliris (eculizumab) (Drug)
结局指标
主要结局
Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52
时间窗: From Week 14 to Week 26 and from Week 40 to Week 52
Lactate Dehydrogenase (U/L) at Week 26
时间窗: Week 26
次要结局
未报告次要终点