REPEATED DOSES OF LPJ-394 IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

这是一项前瞻性多中心、双盲、安慰剂对照的II-III期试验，其中将测试一种研究性新药LPJ 394减少双链DNA抗体（抗dsDNA）产生的能力，并限制狼疮肾炎患者活动性肾病的发作。 受试者将接受为期52周的药物治疗，之后将进行为期6个月的随访，以评估临床狼疮活动，抗DNA水平和健康状况。 这项研究正在进行III期开放标签试验。

This is a prospective multi-center double-blind, placebo-controlled Phase II-III trial in which an investigational new drug, LPJ 394, will be tested for its ability to reduce the production of antibodies to double stranded DNA (anti-dsDNA) and limit flare-ups of active renal disease in patients with lupus nephritis. The subjects will receive medication for 52 weeks, after which there will be a six month period of follow-up to assess clinical lupus activity, anti-DNA levels and health status. This study is progressing to a phase III open label trial.