RT期刊文章SR电子T1的安全性和耐受性Anti-LINGO-1单克隆抗体在急性视神经炎BIIB033:更新试验(P7.203)摩根富林明神经病学神经学乔FD Lippincott Williams &威尔金斯SP P7.203 VO 84 14补充A1斯蒂芬妮·弗里曼A1骰子游戏Vanopdenbosch A1首页赫尔穆特•Butzkueven A1 Tjalf Ziemssen A1 Orhan Aktas A1福克Ziemssen A1卢卡Massacesi A1易茶A1 Lei徐A1迭戈Cadavid年2015 UL //www.ez-admanager.com/content/84/14_Supplement/P7.203.abstract AB目的:确定BIIB033的安全性和耐受性,人类Anti-LINGO-1 first-in-class单克隆抗体,在急性视神经炎(AON)。背景:怡安的炎性脱髓鞘和轴突损伤特征会导致永久性的视觉缺陷。拮抗的作用LINGO-1(富亮氨酸重复和免疫球蛋白domain-containing神经突产物抑制剂receptor-interacting蛋白1),CNS-specific膜糖蛋白,已经显示出改善中枢神经系统remyelination和neuroaxonal保护脱髓鞘疾病的临床前模型中。BIIB033是人类单克隆抗体对抗LINGO-1和已被证明是安全和耐受性良好在第一阶段的研究在健康的志愿者进行与多发性硬化症和主题。在受试者的安全性和耐受性BIIB033怡安此前没有评估。设计/方法:更新(NCT01721161)是一个持续的,第二阶段,随机,双盲,安慰剂对照,与这些相应平行的组织研究对象经历了第一集的单边怡安(一定是第四大剂量甲基强的松龙治疗随机化之前)。(18 - 55岁)的受试者随机1:1接受安慰剂或100毫克/公斤BIIB033 IV每隔4周(6总剂量)。后续将扩展到32周,12周后最后一次剂量。安全人口包括所有受试者接受蠅1剂量的治疗研究。安全评估包括不良事件分析、临床实验室结果(血液学、血液化学和urinanalysis),体检结果,临床相关的生命体征异常,大脑核磁共振结果,12导心电图读数,测量anti-BIIB033抗体的血液,和怡安的症状和体征。 RESULTS: Eighty-two subjects were randomized to receive BIIB033 or placebo. Assessments of the safety and tolerability of BIIB033 will be presented. CONCLUSIONS: The safety and tolerability of BIIB033 in the treatment of AON are important factors to support the ongoing clinical development of anti-LINGO-1 for CNS demyelinating diseases. Study Supported by: Biogen IdecDisclosure: Dr. Freeman has received personal compensation for activities with Biogen Idec as an employee. Dr. Vanopdenbosch has received personal compensation for activities with Biogen Idec, Genzyme Corporation, Novartis, and Merck Serono. Dr. Butzkueven has received personal compensation for activities with Novartis, Merck Serono, and Biogen Idec as a consultant and/or advisor. Dr. Ziemssen has nothing to disclose. Dr. Aktas has received personal compensation for activities with Bayer, Biogen Idec, Genzyme, Novartis, Teva Neuroscience, and Medimmune as an advisor. Dr. Ziemssen has received personal compensation for activities with Alimera Sciences, Inc., Allergan, Inc., Bayer Healthcare, and Novartis, Dr. Massacesi has received research support from Biogen Idec and Genzyme. Dr. Chai has received personal compensation for activities with Biogen Idec as en employee. Dr. Xu has received personal compensation for activities with Biogen Idec as an employee. Dr. Cadavid has received personal compensation for activities with Biogen Idec as an employee.Thursday, April 23 2015, 2:00 pm-6:30 pm