全身性重症筋無力症患者におけるエフガルチギモドPH20皮下投与の長期安全性および忍容性の評価

基本情報

NCT ID

NCT04818671

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

184

治験依頼者名

argenx

概要

The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection. Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).

対象疾患

介入

依頼者（Sponsor）