[Translation] A pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving angiotensin II receptor blockers (ARBs)
这项关键性随机双盲研究的目的是在正在接受ARB治疗的成人FSGS患者中评价DMX-200 120 mg每日两次(BID)给药与安慰剂相比在104周治疗期内的有效性和安全性。双盲期之后将为开放性扩展期(OLE),旨在评估DMX-200至多额外2年治疗的长期有效性和安全性。
[Translation] The purpose of this pivotal, randomized, double-blind study is to evaluate the efficacy and safety of DMX-200 120 mg twice daily (BID) compared to placebo over a 104-week treatment period in adult patients with FSGS who are currently receiving ARB therapy. The double-blind period will be followed by an open-label extension period (OLE) to evaluate the long-term efficacy and safety of DMX-200 for up to an additional 2 years of treatment.