A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis
第3相
早期終了
NCT05265728
| 対象疾患 | Multiple Sclerosis, Relapsing-Remitting |
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| 相 | 第3相 |
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| スポンサー | Biogen |
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| ステータス | 早期終了 |
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| 参加者数 | 21 名 |
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| 介入（薬剤） | Natalizumab |
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| 開始日 | 2022年4月26日 |
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| 完了日 | 2024年1月18日 |
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| 結果公開日 | 2025年11月25日 |
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概要
The primary objective of this study is to evaluate the efficacy of natalizumab 300 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) administrations up to 24 weeks in Japanese participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of the study are to evaluate other clinical and magnetic resonance imaging (MRI) measures of efficacy of natalizumab 300 mg SC Q4W administrations in Japanese participants with RRMS, to evaluate the safety, tolerability, and immunogenicity of natalizumab 300 mg SC Q4W administrations up to 48 weeks in Japanese participants with RRMS, to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of natalizumab 300 mg SC Q4W administrations up to 24 weeks and for an additional 24 weeks in Japanese participants with RRMS.
Part 1: Cumulative Number of New Active Lesions up to Week 24 Identified Using Brain Magnetic Resonance Imaging (MRI) Scans
Up to Week 24 · number of lesions
| Natalizumab | 0.4 ± 0.60 number of lesions |
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| Least Square Mean (LS mean) | 0.37 (95% CI 0.18–0.76) |
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