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
3期
提前终止
NCT05265728
| 适应症 | Multiple Sclerosis, Relapsing-Remitting |
|---|
| 分期 | 3期 |
|---|
| 申办方 | Biogen |
|---|
| 状态 | 提前终止 |
|---|
| 受试者人数 | 21 人 |
|---|
| 干预（药物） | Natalizumab |
|---|
| 开始日期 | 2022年4月26日 |
|---|
| 完成日期 | 2024年1月18日 |
|---|
| 结果公布日 | 2025年11月25日 |
|---|
摘要
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 |
|---|
| Least Square Mean (LS mean) | 0.37 (95% CI 0.18–0.76) |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
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。