一项在增生性狼疮性肾炎 (LN) 或免疫球蛋白 A 肾病 (IgAN) 成人受试者中评估 ALXN2050 的疗效和安全性的 II 期、随机、双盲、安慰剂对照、剂量探索研究
[Translation] A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Subjects with Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
ALXN2050 是一种强效、可逆口服小分子 D 因子 (FD) 抑制剂,是补体旁路途径 (AP) 的重要组成部分。补体系统参与增生性 LN 和 免疫球蛋白A肾病 (IgAN) 的病理生理学过程。本研究的目的是评估口服 ALXN2050 与安慰剂相比的疗效和安全性,证明对 FD 抑制有效性的概念验证,并确定解决接受背景标准疗法治疗的 LN 或 IgAN 患者的未满足医疗需求的有效剂量。
[Translation] ALXN2050 is a potent, reversible, small molecule, orally available factor D (FD) inhibitor, an essential component of the alternative complement pathway (AP). The complement system is involved in the pathophysiology of proliferative LN and immunoglobulin A nephropathy (IgAN). The objectives of this study were to evaluate the efficacy and safety of oral ALXN2050 compared to placebo, demonstrate proof-of-concept efficacy for FD suppression, and determine effective doses to address unmet medical needs in patients with LN or IgAN treated with background standard of care therapies .
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