CTRI/2019/05/019148进行中（未招募）3 期
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
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- The primary objective of this study is to demonstrate comparable clinical efficacy of SB12 and Soliris®, by evaluating the lactate dehydrogenase (LDH) in subjects with paroxysmal nocturnal haemoglobinuria (PNH).
研究概览
简要总结
The primary objective of this study is to demonstrate comparable clinical efficacy of SB12 and Soliris®, by evaluating the lactate dehydrogenase (LDH) in subjects with paroxysmal nocturnal haemoglobinuria (PNH). 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. Subjects will be randomised in a 1:1 ratio to treatment sequence I (SB12 to Soliris®) or treatment sequence II (Soliris® to SB12). 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
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female aged 18 or older at the time of signing the informed consent form (ICF), if local regulations are different in this regard, follow the local regulations.
- •Documented diagnosis of PNH.
- •Presence of the PNH white blood cell (WBC) clone more than or equal to 10% by high-sensitivity flow cytometry at Screening.
- •Documented LDH level more than or equal to 1.5 × upper limit of normal (ULN) at Screening.
- •History of transfusion for anaemia within 12 months prior to Screening or having PNH-related symptoms (e.g., fatigue, haemoglobinuria, abdominal pain, chest pain, shortness of breath [dyspnoea], dysphagia, erectile dysfunction) at Screening.
- •All subjects must be vaccinated against Neisseria meningitidis within 3 years prior to or on Day 1 in accordance with current local guidelines or Soliris ® Summary of Product Characteristics (SmPC) to reduce the risk of meningococcal infection.
- •Female subjects who are not pregnant or nursing at Screening and on initiation of study drug (Day 1) and who are not planning to become pregnant from Screening until 5 months after the last dose of study drug.
- •Subjects and their partners of childbearing potential (female or male) who agree to use of a highly effective contraceptive method (e.g., established use of oral, injected or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine system, male sterilisation, or true abstinence [see Section 8.4.1]) from Screening until 5 months after the last dose of study drug.
- •Subjects must be able to understand the implications of taking part in the study and be willing to follow the study instructions and requirements fully.
- •Subjects must be able to provide informed consent, which must be obtained prior to any study related procedures.
排除标准
- •Previous treatment with a complement pathway inhibitor (including eculizumab).
- •Known hypersensitivity to the investigational product (IP) or any of the ingredients or excipients of the IP.
- •Abnormal haematological parameters at Screening defined as the following: a.
- •Absolute neutrophil count (ANC) less than or equal to 500/mm3 b.
- •Platelet count less than 70,000/mm3
- •History of meningococcal disease.
- •History of bone marrow transplantation.
- •History of serious thrombotic event (e.g., stroke, myocardial infarction, pulmonary embolism, etc.).
- •Known or suspected active bacterial, virus, fungal infection within 30 days prior to initiation of study drug (Day 1).
- •Known history of human immunodeficiency virus (HIV) infection or have positive results at Screening.
- •Concomitant use of any of the following medications is prohibited if the following conditions apply.
- •Erythropoietin, systemic corticosteroids, low-molecular-weight heparins, iron supplements,and androgen therapy that has not been on a stable dose for at least 4 weeks prior to initiation of study drug (Day 1).
- •Warfarin with an unstable international normalized ratio (INR) for at least 4 weeks prior to initiation of study drug (Day 1).
- •Cyclosporine that has not been on a stable dose for at least 8 weeks prior to initiation of study drug (Day 1).
- •Subjects who have received or participated in another investigational drug, device, or procedures within 30 days or within 5 half-lives of that IP prior to Screening, whichever is greater.
- •History of malignancy within 5 years prior to Screening, except for curatively treated carcinoma in situ of uterine cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
- •Any other cardiac, hepatic, immunologic, pulmonary, rheumatoid disease, other conditions causing rise in LDH (e.g., tumours, muscular dystrophies, liver and bile disease, etc.), or the disorder which, at the discretion of the Investigator, will put the subjects at risk if they are enrolled.
- •Other unspecified reasons that, at the discretion of the Investigator or Sponsor, make the subjects unsuitable for enrollment.
结局指标
主要结局
The primary objective of this study is to demonstrate comparable clinical efficacy of SB12 and Soliris®, by evaluating the lactate dehydrogenase (LDH) in subjects with paroxysmal nocturnal haemoglobinuria (PNH).
时间窗: 1. LDH level (U/L) at Week 26 | 2. Area under the effect curve (AUEC) of LDH from Week 14 to Week 26 and from Week 40 to Week 52
次要结局
- To evaluate the efficacy of SB12 compared to Soliris® by(-LDH profile over time)
- To evaluate the safety and tolerability of SB12 compared to Soliris®(Safety endpoints)
- To evaluate the pharmacokinetic (PK) of SB12 compared to Soliris®(PK endpoint)
- To evaluate the immunogenicity of SB12 compared to Soliris®(Immunogenicity endpoints)
- To evaluate the pharmacodynamic (PD) of SB12 compared to Soliris®(PD endpoint)
研究者
研究点 (5)
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