全身性重症筋無力症患者における、皮下投与されたエフガルチギモドPH20 SCと静脈内投与されたエフガルチギモドの薬力学的非劣性の評価

基本情報

NCT ID: NCT04735432
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: 110
治験依頼者名: argenx

概要

The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)

対象疾患

Generalized Myasthenia Gravis

介入

efgartigimod PH20 SC(BIOLOGICAL)

efgartigimod IV(BIOLOGICAL)

依頼者（Sponsor）

Argenx(INDUSTRY)