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

L 733,723 在银屑病患者中的安全性、耐受性和生物活性

• 批准号: 6274493
• 负责人: CYNTHIA GUZZO
• 金额: $ 2.5万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-04-15 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274493
• 关键词: chemical structure function; clinical research; clinical trials; cyclosporines; dosage; drug screening /evaluation; human subject; human therapy evaluation; outcomes research; psoriasis; skin disorder chemotherapy

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 initially 0.15 mg/kg, 0.30 mg, and 0.45 mg/kg q 12 hr. for 2 weeks. Based on results from these, the best dosage schedule for the study drug was to be chosen and patients were to be randomized to receive study drug, placebo or cyclosporine for 8 weeks. However, based on results from 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 time was extended to 12 weeks. This protocol was continued as a multicenter randomized, double-blinded, 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.

这是一项多中心、多次给药研究，在中度 严重银屑病（一项随机，安慰剂对照，双盲， 系列4面板设计）。 剂量水平最初包括0.15 mg/kg、0.30 mg/kg mg和0.45 mg/kg q12 hr，持续2周。 根据这些结果， 选择研究药物的最佳给药方案， 患者随机接受研究药物、安慰剂或 环孢素8周。 然而，根据第一部分的结果， 在本研究中，对方案的第二部分进行了修改。 越高 剂量减少至0.26 mg/kg，每12小时一次，治疗时间为 延长至12周。该方案继续作为多中心研究， 随机、双盲、平行组多次口服给药研究， 评价L-733725与环孢素相比的耐受性和疗效 A与安慰剂相比，治疗中重度 慢性斑块型银屑病。