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）の再発性多発性硬化症（RMS）研究（GEMINI 1）

基本情報

NCT ID: NCT04410978
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: 974
治験依頼者名: Sanofi

概要

Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

対象疾患

Relapsing Multiple Sclerosis

介入

Tolebrutinib(DRUG)

Teriflunomide(DRUG)

Placebo to match Tolebrutinib(DRUG)

Placebo to match Teriflunomide(DRUG)

依頼者（Sponsor）

サノフィ株式会社(INDUSTRY)