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非在研适应症- |
最高研发阶段批准上市 |
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首次获批日期2023-06-20 |
A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Ocular Myasthenia Gravis
The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.
一项探究皮下注射efgartigimod PH20在治疗大疱性类天疱疮成人受试者中的有效性和安全性的II/III期、随机、双盲、安慰剂对照、平行组研究
评价皮下注射efgartigimod PH20治疗大疱性类天疱疮(BP)受试者获得持续缓解的有效性
评价 Efgartigimod PH20 SC在ITP患者中安全性和有效性的开放及长期研究
在原发 ITP 成人患者中评估 efgartigimod PH20 SC 的安全性和耐受性
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