TOLERABILITY/PHARMACOKINETICS OF DAB389 IL 2 IN PATIENTS WITH SEVERE PSORIASIS

这是一项开放标签、剂量递增的多中心试验， 3剂的安全性、耐受性和药代动力学参数 DAB 389 IL-2在重度银屑病患者中的应用 剂量选择 因为之前的研究已经表明， 在较高剂量下发生更频繁，并且在 所有剂量 该方案探索了一种较低的和多样化的治疗方法， schedule. 还将评估疗效。 总共45名患者将被分配到剂量递增组 3个剂量组之一（0.5、1.5和5.0 ug/kg/天）。 药物 每隔一周给药3天，持续8周。

This is an open-label, dose-escalating multi-center trial to determine the safety, tolerability, and pharmacokinetic parameter of 3 doses of DAB389IL-2 in patients with severe psoriasis. The doses were chosen because previous studies have demonstrated that adverse experiences occur more frequently at higher doses and efficacy has been present at all doses. This protocol explores a lower and varied treatment schedule. Efficacy will also be assessed. A total of forty-five patients will be assigned in a dose escalating manner to one of the 3 dose groups (0.5, 1.5, and 5.0 ug/kg/day). Drug is administered 3 days every other week for 8 weeks.