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ブルトン型チロシンキナーゼ（BTK）阻害剤トレブルチニブ（SAR442168）の一次性進行性多発性硬化症（PPMS）試験（PERSEUS）
基本情報
- NCT ID
- NCT04458051
- ステータス
- 完了
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 767
- 治験依頼者名
- Sanofi
概要
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168
対象疾患
Primary Progressive Multiple Sclerosis
介入
Tolebrutinib(DRUG)
Placebo(DRUG)
依頼者（Sponsor）
サノフィ株式会社(INDUSTRY)