HU23F2G IN ACUTE EXACERBATIONS OF MULTIPLE SCLEROSIS

多发性硬化症急性加重中的 HU23F2G

• 批准号: 6121136
• 负责人: Jerry Saul Wolinsky
• 金额: $ 1.51万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6121136
• 关键词: clinical research; drug screening /evaluation; hormone therapy; human subject; human therapy evaluation; immunotherapy; methylprednisolone; monoclonal antibody; multiple sclerosis

The study was designed to evaluate the efficacy & safety of Hu23F2G administered intravenously to patients with acute exacerbations of multiple sclerosis (MS) as compared to placebo and corticosteroid treatment. Hu23F2G is a humanized anti-CD18 monoclonal antibody which has been effective in a non-human primate experimental model of MS. This was a Phase 2 study in which patients will be randomized to treatment for 3 days with placebo, methylprednisoline, or Hu23F2G at 1 or 2 mg/kg. Subjects were be followed for 1 year after treatment. The results of this trial are under analysis.

该研究被设计为评估与安慰剂和皮质类固醇治疗相比，静脉内给予患有多发性硬化症（MS）急性加重的患者的Hu 23 F2 G的功效和安全性。Hu 23 F2 G是一种人源化抗CD 18单克隆抗体，其在MS的非人灵长类动物实验模型中有效。这是一项2期研究，其中患者将随机接受安慰剂、甲泼尼龙或1或2 mg/kg的Hu 23 F2 G治疗3天。 受试者在治疗后随访1年。 这项试验的结果正在分析中。