DOSE RESPONSE STUDY OF BG9273(LFA 3 & IGG1 FUSION PROTEIN)

有待检验的假设是，LFA-III IgG1融合蛋白阻止T细胞激活将对斑块型银屑病患者具有有益的治疗效果。克鲁格博士设计的一项多中心研究已经启动，计划在犹他州中心招募10名患者。所有中心将招募200名患者，目标是让160名受试者完成至少8周的治疗。被测试的试剂是一种二聚体蛋白，含有LFA-III的第一个胞外结构域，与人IgG1的铰链片段和恒定区融合。LFA-III部分与T细胞上的CD2受体结合，而IgG1部分与抗原提呈细胞上的Fc受体结合。该分子旨在通过阻断皮肤抗原呈递细胞上表达的共刺激分子介导的增强的抗原呈递能力来阻断T细胞的激活。初步证据表明，该制剂是安全的，但疗效数据尚未分析。

The hypothesis to be tested is that prevention of T-cell activation by LFA-III IgG1 fusion protein will have a beneficial therapeutic effect in patients with plaque psoriasis. A multicenter study designed by Dr. Krueger has been mounted, with plans to enroll ten patients at the Utah Center. Two-hundred patients will be enrolled in all centers, with a goal of having 160 subjects complete at least eight weeks of therapy. The agent to be tested is a dimeric protein containing the first extracellular domain of LFA-III fused to the hinged segment and constant regions of human IgG1. The LFA-III portion binds the CD2 receptor on T-cells, and the IgG1 portion binds to the Fc receptor on antigen-presenting cells. The molecule was designed to block T-cell activation by blocking the enhanced antigen-presenting capacity mediated by the co-stimulatory molecules expressed on antigen-presenting cells of the skin. Preliminary evidence suggests that the agent is safe, but efficacy data have not yet been analyzed.