A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy - ARGX-113-2011

Argenx0 个研究点目标入组 240 人开始时间: 2023年5月12日最近更新: 2024年7月22日

适应症

试验速览

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•Has completed ARGX-113-2007, Is capable of providing signed informed consent and complying with protocol requirements, Agrees to use contraceptive measures consistent with local regulations and the following: • women of childbearing potential (WOCBP) must have a negative urine pregnancy test at baseline before receiving investigational medicinal product (IMP).

•Intention to have major surgery during the ARGX-113-2011 study period; or any other medical condition that has arisen since enrollment in ARGX-113-2007, that in the investigator’s opinion, would confound the results of the study or put the participant at undue risk, Known hypersensitivity to investigational medicinal product (IMP) or 1 of its excipients, Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness, Permanent discontinuation of investigational medicinal product (IMP) in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit., Diagnosis with a deselected subtype of IIM based on the analysis of the phase 2 stage data in ARGX-113-2007, unless the investigator determines that the participant is benefiting from investigational medicinal product (IMP) as defined by a score of much better” or moderately better” on the Clinical Global Impression of Change (CGI-C) and Patient Global Impression of Change (PGI-C) assessments for at least 12 weeks, and that enrolling in the study is in the participant’s best interest

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