再発寛解型多発性硬化症の日本人患者を対象とした、ナタリズマブ（BG00002）の複数回皮下投与の有効性、安全性、薬物動態および薬力学を評価する試験

基本情報

NCT ID

NCT05265728

ステータス

中止

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

21

治験依頼者名

Biogen

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (12)