WCN23-0405 AN ADAPTIVE, DOSE-EXPLORATION, PHASE 2 TRIAL EVALUATING EFFICACY AND SAFETY OF IPTACOPAN IN COMBINATION WITH STANDARD-OF-CARE WITH AND WITHOUT ORAL CORTICOSTEROIDS IN ACTIVE LUPUS NEPHRITIS

VELDANDI U. K; Anders H. J; Chan T. MJayne DMahajan PLinnik JWebb N. J. AMeier MRovin B

首页> 外文期刊>asian journal of surgery >WCN23-0405 AN ADAPTIVE, DOSE-EXPLORATION, PHASE 2 TRIAL EVALUATING EFFICACY AND SAFETY OF IPTACOPAN IN COMBINATION WITH STANDARD-OF-CARE WITH AND WITHOUT ORAL CORTICOSTEROIDS IN ACTIVE LUPUS NEPHRITIS

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WCN23-0405 AN ADAPTIVE, DOSE-EXPLORATION, PHASE 2 TRIAL EVALUATING EFFICACY AND SAFETY OF IPTACOPAN IN COMBINATION WITH STANDARD-OF-CARE WITH AND WITHOUT ORAL CORTICOSTEROIDS IN ACTIVE LUPUS NEPHRITIS

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Lupus nephritis (LN) is a renal manifestation seen in up to 60 of patients with systemic lupus erythematosus. With the current standard of care (SoC: high-dose followed by tapering oral corticosteroids CS plus cyclophosphamide or mycophenolate mofetil/sodium MMF/MPS) only 30–50 of patients achieve a complete clinical renal response, and up to 35 of responders may relapse. Further, 10-20 of patients progress to kidney failure within 10 years of diagnosis. Chronic CS therapy is associated with short and long-term adverse events. In LN, complement activation by immune complexes through the classical pathway and subsequent amplification by the alternative complement pathway (AP)is a key driver of kidney injury. Nearly 30 of patients with LN also have anti-C3 autoantibodies that contribute to overactivation of the AP. Thus, a targeted therapy to prevent activation of the AP might be beneficial. This study aims to evaluate the efficacy and safety of iptacopan (an oral proximal complement inhibitor that specifically binds to factor B and inhibits the AP) as an add-on to current SoC with or without oral CS in patients with active LN.

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《asian journal of surgery》 |2023年第3期|66-66|共1页
作者
VELDANDI U. K; Anders H. J; Chan T. MJayne DMahajan PLinnik JWebb N. J. AMeier MRovin B;
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作者单位

Novartis Healthcare Pvt Ltd,Global Drug Development;

University Hospital- LMU Munich,Medicine IV;

University of Hong Kong,School of Clinical MedicineUniversity of Cambridge,MedicineNovartis Healthcare Pvt Ltd,GDO-Trial ManagementNovartis Pharma AG,GDD BiostatisticsNovartis Pharma AG,Global Drug DevelopmentThe Ohio State University Wexner Medical Centre,Internal Medicine;

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WCN23-0405 AN ADAPTIVE, DOSE-EXPLORATION, PHASE 2 TRIAL EVALUATING EFFICACY AND SAFETY OF IPTACOPAN IN COMBINATION WITH STANDARD-OF-CARE WITH AND WITHOUT ORAL CORTICOSTEROIDS IN ACTIVE LUPUS NEPHRITIS

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