SAFETY, TOLERABILITY, AND BIOLOGIC ACTIVITY OF L 733,723 IN PSORIATIC PATIENTS

这是一项多中心、多剂量的研究，研究对象为中度到中度的 严重银屑病(随机、安慰剂对照、双盲、系列 4小组设计)剂量水平包括0.15 mg/kg、0.30 mg/kg和0.45 mg/kg Mg/kg，q 12小时。患者接受为期2周的治疗。基于 结果根据这些剂量水平，患者随后将在 研究的第二部分在最佳给药方案下也随机进行 接受安慰剂或环孢素治疗8周。然而，基于 研究的第一部分、方案的第二部分的结果 是经过修改的。较高剂量降至0.26 mg/kg，q12小时。以及 治疗延长至12周。这是作为一种 目前正在进行《儿童权利公约》中的单独议定书。(多中心随机、 双盲、平行、多次口服给药研究 L-733725与环孢素A与安慰剂的耐受性和疗效 在治疗中重度慢性斑块型患者中 牛皮癣)。

This was a multi-center, multiple dose study in patients with moderate to severe psoriasis (a randomized, placebo-controlled, double-blind, serial 4 panel design) Dose levels included 0.15 mg/kg, 0.30 mg/kg, and 0.45 mg/kg q 12 hr. and patients were to receive therapy for 2 weeks. Based on results from these dose levels, patients were then to be treated in the second part of the study at the best dosage schedule and also randomized to receive placebo or cyclosporine for 8 weeks. However, based on results for the first part of the study, the second part of the protocol was modified. The higher dose was reduced to 0.26 mg/kg q 12 hr. and the treatment extension was extended to 12 weeks. This was continued as a separate protocol now in progress in the CRC. (A multicenter randomized, double-blind, parallel-group, multiple oral dose study to evaluate the tolerability and efficacy of L-733725 versus cyclosporine A versus placebo in the treatment of patients with moderate to severe chronic plaque-type psoriasis).