A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
Фаза 3
Завершено
NCT04058158
| Заболевание | Paroxysmal Nocturnal Hemoglobinuria |
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| Фаза | Фаза 3 |
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| Спонсор | Samsung Bioepis Co., Ltd. |
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| Статус | Завершено |
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| Участники | 50 участн. |
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| Вмешательство | SB12 (proposed eculizumab biosimilar), Soliris (eculizumab) |
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| Дата начала | 7.08.2019 |
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| Дата завершения | 21.09.2021 |
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| Публикация результатов | 26.03.2024 |
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Кратко
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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