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
3상
조기 종료
NCT05265728
| 대상 질환 | Multiple Sclerosis, Relapsing-Remitting |
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| 임상 단계 | 3상 |
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| 스폰서 | Biogen |
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| 상태 | 조기 종료 |
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| 참여자 수 | 21 명 |
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| 중재(약물) | Natalizumab |
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| 시작일 | 2022년 4월 26일 |
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| 완료일 | 2024년 1월 18일 |
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| 결과 공개일 | 2025년 11월 25일 |
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요약
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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