A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
3期
已完成
NCT04058158
| 适应症 | Paroxysmal Nocturnal Hemoglobinuria |
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| 分期 | 3期 |
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| 申办方 | Samsung Bioepis Co., Ltd. |
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| 状态 | 已完成 |
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| 受试者人数 | 50 人 |
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| 干预（药物） | SB12 (proposed eculizumab biosimilar), Soliris (eculizumab) |
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| 开始日期 | 2019年8月7日 |
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| 完成日期 | 2021年9月21日 |
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| 结果公布日 | 2024年3月26日 |
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摘要
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.
Lactate Dehydrogenase (U/L) at Week 26
Week 26 · U/L
| SB12 | 284.20 ± 456.73 U/L |
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| Soliris | 249.72 ± 103.67 U/L |
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| Least squares mean difference | 34.48 (95% CI -47.66–116.62) |
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Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52
From Week 14 to Week 26 and from Week 40 to Week 52 · U/L
| SB12 | 279.65 ± 325.37 U/L |
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| Soliris | 258.73 ± 95.09 U/L |
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| Ratio of geometric least squares mean | 1.08 (95% CI 0.95–1.23) |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。