PPD Laboratories (Beijing) Co., Ltd

Compare the efficacy of redasemtide with placebo Assess the safety and tolerability of redasemtide

ALXN2050 is a potent, reversible, oral, small molecule inhibitor of factor D (FD), an important component of the complement alternative pathway (AP). The complement system is involved in the pathophysiology of proliferative LN and immunoglobulin A nephropathy (IgAN). The objectives of this study are to evaluate the efficacy and safety of oral ALXN2050 compared to placebo, demonstrate proof of concept for the effectiveness of FD inhibition, and determine an effective dose to address unmet medical needs in patients with LN or IgAN treated with background standard of care.

Primary Objectives: To demonstrate that the antiplatelet effect of ticagrelor can be reversed after initiation of intravenous PB2452 in patients who experience uncontrolled massive/life-threatening bleeding or require urgent surgery/invasive procedures after ticagrelor treatment using the VerifyNow™ PRUTest™ (VerifyNow™, 2016) platelet reactivity assay; To demonstrate the effect of PB2452 in achieving effective hemostasis after administration of PB2452 in patients who experience uncontrolled massive/life-threatening bleeding or require urgent surgery/invasive procedures after ticagrelor treatment Secondary Objectives: To demonstrate that the antiplatelet effect of ticagrelor can be reversed after intravenous PB2452 in patients who experience uncontrolled massive/life-threatening bleeding or require urgent surgery/invasive procedures after ticagrelor treatment using the PRU and platelet reactivity index (PRI) measured using the vasodilator stimulated phosphoprotein (VASP) assay Other Prespecified Objectives: To evaluate the efficacy of all enrolled patients receiving PB2452 Clinical outcomes of platelet function; evaluate the pharmacokinetic (PK) profile of intravenously administered PB2452, ticagrelor, and ticagrelor active metabolite (TAM); evaluate the reversal effect of ticagrelor on P-selectin and optionally other platelet function-related biomarkers Safety Objectives: To evaluate the safety, tolerability, and immunogenicity of PB2452 in patients receiving ticagrelor.