A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

UCB Japan Co., Ltd.1 个研究点目标入组 18 人开始时间: 待定最近更新: 2022年7月5日

试验速览

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•Study participant must be >=18 years of age, at the time of signing the informed consent
•Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at Visit 1, based on study participants history and supported by previous evaluations
•Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) at Screening (Visit 1). The presence of autoantibodies may be confirmed with repeat testing at Visit 1
•Study participant has Myasthenia Gravis Foundation of America (MGFA) Class ll to IVa at Visit 1
•Study participant with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of at least 3 AND a quantitative myasthenia gravis (QMG) score of at least 11 at Visit 1 and at Baseline (Visit 2)
•Study participant is considered for additional treatment such as intravenous immunoglobulin g(IVIg) or plasma exchange (PEX) by the Investigator

•Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP)
•Study participant has experienced hypersensitivity reaction after exposure to other antineonatal Fc receptor (FcRn) drugs
•Study participant with severe (defined as Grade 3 on the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis at Visit 1 or Visit 2

发起方

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