Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy

开始日期2022-11-30

申办/合作机构

Otsuka Pharmaceutical Development & Commercialization, Inc.

CTRI/2022/11/047572 / Active, not recruiting临床3期

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluatethe Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy - VISIONARY

开始日期2022-11-15

申办/合作机构-

CTR20222305 / Active, not recruiting临床1期

一项在中国健康受试者中评估Sibeprenlimab皮下给药的药代动力学、安全性、耐受性和药效学的随机、开放性、Ⅰ期临床试验

● 评价中国健康受试者单次皮下注射Sibeprenlimab的PK特征 ● 评价中国健康受试者皮下注射Sibeprenlimab的安全性和耐受性

开始日期2022-10-18

申办/合作机构

Otsuka Pharmaceutical Development & Commercialization, Inc.

[+3]

100 项与 Sibeprenlimab 相关的临床结果

登录后查看更多信息

100 项与 Sibeprenlimab 相关的转化医学

登录后查看更多信息

100 项与 Sibeprenlimab 相关的专利（医药）

登录后查看更多信息

项与 Sibeprenlimab 相关的文献（医药）

2024-01-04·The New England journal of medicine1区 · 医学

A Phase 2 Trial of Sibeprenlimab in Patients with IgA Nephropathy

1区 · 医学

Article

作者: Mathur, Mohit ; Chan, Tak Mao ; Sahay, Manisha ; Pereira, Brian J G ; Yarbrough, Jill ; Wong, Muh Geot ; Oh, Kook-Hwan ; Barratt, Jonathan ; Xia, Jing ; Chacko, Bobby ; Kooienga, Laura ; Suzuki, Yusuke

BACKGROUND:

A proliferation-inducing ligand (APRIL) is implicated in the pathogenesis of IgA nephropathy. Sibeprenlimab is a humanized IgG2 monoclonal antibody that binds to and neutralizes APRIL.

METHODS:

In this phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial, we randomly assigned adults with biopsy-confirmed IgA nephropathy who were at high risk for disease progression, despite having received standard-care treatment, in a 1:1:1:1 ratio to receive intravenous sibeprenlimab at a dose of 2, 4, or 8 mg per kilogram of body weight or placebo once monthly for 12 months. The primary end point was the change from baseline in the log-transformed 24-hour urinary protein-to-creatinine ratio at month 12. Secondary end points included the change from baseline in the estimated glomerular filtration rate (eGFR) at month 12. Safety was also assessed.

RESULTS:

Among 155 patients who underwent randomization, 38 received sibeprenlimab at a dose of 2 mg per kilogram, 41 received sibeprenlimab at a dose of 4 mg per kilogram, 38 received sibeprenlimab at a dose of 8 mg per kilogram, and 38 received placebo. At 12 months, the geometric mean ratio reduction (±SE) from baseline in the 24-hour urinary protein-to-creatinine ratio was 47.2±8.2%, 58.8±6.1%, 62.0±5.7%, and 20.0±12.6% in the sibeprenlimab 2-mg, 4-mg, and 8-mg groups and the placebo group, respectively. At 12 months, the least-squares mean (±SE) change from baseline in eGFR was -2.7±1.8, 0.2±1.7, -1.5±1.8, and -7.4±1.8 ml per minute per 1.73 m² in the sibeprenlimab 2-mg, 4-mg, and 8-mg groups and the placebo group, respectively. The incidence of adverse events that occurred after the start of administration of sibeprenlimab or placebo was 78.6% in the pooled sibeprenlimab groups and 71.1% in the placebo group.

CONCLUSIONS:

In patients with IgA nephropathy, 12 months of treatment with sibeprenlimab resulted in a significantly greater decrease in proteinuria than placebo. (Funded by Visterra; ENVISION ClinicalTrials.gov number, NCT04287985; EudraCT number, 2019-002531-29.).

2023-12-04·Clinical kidney journal

The contribution of a proliferation-inducing ligand (APRIL) and other TNF superfamily members in pathogenesis and progression of IgA nephropathy

Review

作者: Barratt, Jonathan ; Yeo, See Cheng

ABSTRACT:

Advances in our understanding of the pathogenesis of immunoglobulin A nephropathy (IgAN) have led to the identification of novel therapeutic targets and potential disease-specific treatments. Specifically, a proliferation-inducing ligand (APRIL) has been implicated in the pathogenesis of IgAN, mediating B-cell dysregulation and overproduction of pathogenic galactose-deficient IgA1 (Gd-IgA1). Animal and clinical studies support the involvement of APRIL in the pathogenesis and progression of IgAN. An elevated level of APRIL is found in IgAN when compared with controls, which correlates with the level of Gd-IgA1 and associates with more severe disease presentation and worse outcomes. Conversely, anti-APRIL therapy reduces pathogenic Gd-IgA1 and IgA immune complex formation and ameliorates the severity of kidney inflammation and injury. Genome-wide association studies in IgAN have identified TNFSF13 and TNFRSF13B, a cytokine ligand-receptor gene pair encoding APRIL and its receptor, respectively, as risk susceptibility loci in IgAN, further supporting the causal role of the APRIL signalling pathway in IgAN. Several novel experimental agents targeting APRIL, including atacicept, telitacicept, zigakibart and sibeprenlimab, are currently under investigation as potential therapies in IgAN. Preliminary results suggest that these agents are well-tolerated, and reduce levels of Gd-IgA1, with corresponding improvement in proteinuria. Further studies are ongoing to confirm the safety and efficacy of anti-APRIL approaches as an effective therapeutic strategy in IgAN.

2023-12-01·Clinical rheumatology

A narrative review of potential drug treatments for nephritis in children with IgA vasculitis (HSP)

Review

作者: Lamond, Megan ; Chetwynd, Andrew J ; Marro, Julien ; Oni, Louise ; Williams, Chloe E C

Abstract:

Immunoglobulin A (IgA) vasculitis (IgAV, also known as Henoch-Schoenlein purpura, HSP) is the most common vasculitis of childhood. It usually presents with a simple, self-limiting disease course; however, a small subset of patients may develop kidney involvement (IgAV-N) which occurs 4–12 weeks after disease onset and is the biggest contributor to long-term morbidity. Treatment currently targets patients with established kidney involvement; however; there is a desire to work towards early prevention of inflammation during the window of opportunity between disease presentation and onset of significant nephritis. There are no clinical trials evaluating drugs which may prevent or halt the progression of nephritis in children with IgAV apart from the early use of corticosteroids which have no benefit. This article summarises the latest scientific evidence and clinical trials that support potential therapeutic targets for IgAV-N that are currently being developed based on the evolving understanding of the pathophysiology of IgAV-N. These span the mucosal immunity, B-cell and T-cell modulation, RAAS inhibition, and regulation of complement pathways, amongst others. Novel drugs that may be considered for use in early nephritis include TRF-budesonide; B-cell inhibiting agents including belimumab, telitacicept, blisibimod, VIS649, and BION-1301; B-cell depleting agents such as rituximab, ofatumumab, and bortezomib; sparsentan; angiotensin converting enzyme inhibitors (ACE-Is); and complement pathway inhibitors including avacopan, iptacopan, and narsoplimab. Further clinical trials, as well as pre-clinical scientific studies, are needed to identify mechanistic pathways as there may be an opportunity to prevent nephritis in this condition.Key Points• Kidney involvement is the main cause of long-term morbidity and mortality in IgA vasculitis despite the current treatment recommendations.• The evolving understanding of the pathophysiology of IgA vasculitis is allowing exploration of novel treatment options which target underlying immune pathways.• Novel treatments currently being trialled in IgA nephropathy may have benefit in IgA vasculitis due to the similarities in the underlying pathophysiology, such as TRF-budesonide, B-cell modulators, and complement inhibitors.• Further studies, including clinical trials of novel drugs, are urgently needed to improve the long-term outcomes for children with IgA vasculitis nephritis.

项与 Sibeprenlimab 相关的新闻（医药）

2024-03-28

·Pharmaceutical Technology

Otsuka and Lundbeck’s schizophrenia treatment gains EC approval

The treatment is indicated for adult schizophrenia patients who have been stabilised with aripiprazole. Credit: Ground Picture / Shutterstock.com. The European Commission (EC) has approved Otsuka Pharmaceutical Europe and H Lundbeck’s Abilify Maintena 720mg/960mg (aripiprazole) for the maintenance treatment of schizophrenia. The treatment is indicated for use in adult schizophrenia patients who have been stabilised with aripiprazole. The approval marks the introduction of the first once-every-two-month long-acting injectable (LAI) antipsychotic in the European Union (EU) for this indication. Designed for bi-monthly dosing through an intramuscular injection into the gluteal muscle, the new formulation of aripiprazole once every two months LAI is offered in a single-chamber prefilled syringe and does not need reconstitution. The EC’s decision extends to all EU member states, Norway, Iceland and Liechtenstein. See Also: China NMPA accepts Astellas’ sBLA for urothelial cancer treatment EC approves Merck’s KEYTRUDA regimen for NSCLC treatment Otsuka Europe medical affairs vice-president and head Dr Peter Gillberg stated: “We welcome the EC approval of aripiprazole once-every-two-months LAI, which represents a significant milestone in offering adult patients with schizophrenia another simplified treatment regimen. “We hope that this treatment may help to mitigate challenges with adherence, and potentially allow patients and their healthcare practitioners to focus on other elements of care.” The approval was based on the results of a 32-week pharmacokinetic bridging clinical trial. This study also assessed the safety and efficacy of Abilify Maintena as primary and secondary endpoints respectively. The once-every-two-month LAI formulation demonstrated plasma concentrations, effectiveness, safety and tolerability profiles in line with the established once-monthly LAI (Abilify Maintena 400mg) dose in 266 adult subjects, 185 of whom were diagnosed with schizophrenia. Lundbeck research and development executive vice-president and head Dr Johan Luthman stated: “Specifically designed for adult patients with schizophrenia who have been stabilised with aripiprazole, this treatment aims to increase patient adherence and convenience, contributing to the careful and comprehensive management of this chronic condition.” Last month, Otsuka received breakthrough therapy designation for its rare kidney disease drug sibeprenlimab from the US Food and Drug Administration.

上市批准突破性疗法临床结果

2024-02-20

·药研发

【药研发0221】信达IGF-1R抗体甲状腺眼病III期研究积极 | AZ创新酶替代疗法中国获批临床...

「本文共：15条资讯，阅读时长约：3分钟」今日头条信达IGF-1R抗体甲状腺眼病III期研究积极。信达生物IGF-1R抗体注射液IBI311治疗甲状腺眼病（TED）患者的中国III期研究（RESTORE-1）达到主要终点。与安慰剂相比，IBI311治疗第24周时患者研究眼的眼球突出应答率（研究眼相对于基线突眼度回退≥2mm，且不伴有对侧眼突眼度增加≥2mm的受试者比例）显著更高（85.8%vs3.8%，95%CI：69.8%-93.9%，P<0.0001）。该公司计划尽快向NMPA递交其新药上市申请（NDA）。国内药讯1.智翔金泰IL-17A单抗银屑病Ⅲ期临床成功。智翔金泰自研IL-17A抗体赛立奇单抗（GR1501）治疗中、重度斑块状银屑病的Ⅲ期临床达到主要终点和次要终点。第12周时，与安慰剂相比，GR1501治疗达到银屑病皮损面积和严重程度指数较基线至少改善75%（PASI 75）的患者比例显著更高（90.7%vs8.6%）；两组皮损清除/几乎清除（PGA0/1）的患者比例分别为74.4%和3.6%。详细结果已发布于期刊British Journal of Dermatology上。2.迈威铁稳态调节单抗获FDA孤儿药资格。迈威生物自主研发的TMPRSS6单抗9MW3011（MWTX-003/DISC-3405）获FDA授予孤儿药资格，用于治疗真性红细胞增多症。9MW3011可通过与靶点特异性结合，上调肝细胞表达铁调素（Hepcidin）的水平，抑制铁的吸收和释放，以调节体内的铁稳态。该新药目前正在中美同步临床开发，拟开发用于包括β-地中海贫血、真性红细胞增多症等与铁稳态相关的疾病。3.AZ创新酶替代疗法中国获批临床。阿斯利康1类生物制品ALXN1850注射液（efzimfotase alfa）获国家药监局临床许可，拟开发作为酶替代疗法用于治疗低磷酸酯酶症（HPP）。ALXN1850具有较长的半衰期。该新药目前正在国际Ⅲ期临床中分别针对此前未接受过asfotase alfa治疗的青少年和成人HPP患者、先前接受过asfotase alfa治疗以及未接受过治疗的儿童HPP患者（2~12岁）评估治疗效果。4.凯思凯迪TRβ激动剂获批NASH临床。凯思凯迪靶向甲状腺受体β（TRβ）的小分子激动剂CS060304获FDA批准开展Ⅰ期临床研究，拟评估用于非酒精性脂肪性肝炎（NASH）适应症的安全性与有效性。临床前研究显示，CS060304在NASH小鼠模型中可显著改善NAS评分和纤维化，具有起效剂量低、药效显著且耐受性良好的特点。该公司计划在中、美同步推进CS060304的临床开发。5.唯源立康HSV外用基因疗法获批临床。北京唯源立康1类生物药WG1025获国家药监局临床许可，其适应症为营养不良型大疱性表皮松解症（DEB）。WG1025是国内首款可重复使用的外用基因疗法，含有两个拷贝全长COL7A1基因的复制缺陷型HSV-1载体，可以在皮肤细胞持续表达功能性VII型胶原蛋白并促进创口愈合。在研究者发起、针对DEB治疗的IIT研究中，WG1025给药后创口完全愈合时间为5-10天，且药物总体耐受性良好。6.百奥赛图与吉利德达成多靶点抗体合作。百奥赛图宣布与吉利德达成抗体评估和选择协议，授权吉利德在三年提名期内使用百奥赛图针对广泛的药物靶点建立的全人抗体库进行相关靶点的抗体评估，合作开发治疗性特定抗体。根据协议，百奥赛图将会获得一笔付款；且针对每个被提名的靶点被选定的抗体，百奥赛图将有权获得选择权行权费，开发、监管和销售里程碑付款，及个位数净销售额分成。国际药讯1.奥希替尼治疗III期肺癌结果积极。阿斯利康第三代EGFR抑制剂奥希替尼（Tagrisso）治疗不可切除、EGFRm突变、III期非小细胞肺癌（NSCLC）经治患者的III期研究LAURA结果积极。与安慰剂相比，Tagrisso在这类难治、脑转移患者中的无进展生存期（PFS）的统计具有显著性改善；患者的总生存期（OS）数据也显示改善趋势。该项研究的总生存期（OS）关键次要终点仍在持续评估中。2.大冢APRIL单抗获IgA肾病突破性疗法认定。大冢制药与Visterra公司开发的细胞因子A增殖诱导配体（APRIL）单抗sibeprenlimab（VIS649）获FDA突破性疗法认定（BTD），用于治疗免疫球蛋白A（IgA）肾病。在Ⅱ期临床中，与安慰剂相比，sibeprenlimab（2mg、4mg和8mg）治疗12个月时患者的蛋白尿水平显著减少，两组患者24小时尿蛋白/肌酐比值（UPCR）的几何平均比值降幅分别为47.2%、58.8%、62.0%和20.0%。3.赛诺菲渐冻症药物Ⅱ期临床未达主要终点。Denali公司与赛诺菲开发的潜在“first-in-class”小分子RIPK1抑制剂SAR443820（DNL788）在治疗肌萎缩性侧索硬化症（ALS，渐冻症）的Ⅱ期Himalaya试验中未能达到显著改善修订版ALS功能评定量表（ALSFRS-R）评分的主要终点。该新药具有中枢神经系统（CNS）高渗透性，主要用于调节eIF2B的活性，以提高神经元存活率。目前，SAR443820也正在Ⅱ期试验中评估治疗多发性硬化症（MS）的潜力。4.首款外用DEB基因疗法临床积极。Krystal Biotech公司基因疗法Vyjuvek的眼药水配方，在用于遗传性营养不良性大疱性表皮松解症（DEB）患者改善眼球表面受累（因病致盲）的临床试验结果积极。受试者在三个月内接受19次Vyjuvek治疗，患者角膜上皮完全愈合；眼压和视网膜完整性恢复正常，并表现出更好的视力。Vyjuvek是FDA针对DEB批准的首款基因疗法，也是首款可重复给药的基因疗法。5.“减肥神药”或可治阿片类药物成瘾。诺和诺德GLP-1类药物利拉鲁肽用于对抗阿片类药物成瘾的小型随机对照试验结果积极。数据显示，使用利拉鲁肽的患者对阿片类药物的渴望减少30%，即使是在最低的利拉鲁肽剂量下，这种效果也很明显。相关研究结果已公布于美国科学促进会（AAAS）议上。目前GLP-1RA精神疾病益处研究仍处于早期阶段。医药热点1.中国生物制药再剥离非核心业务。2月6日，中国生物制药发布公告，该公司同附属公司与两位买方及正大青岛签订协议，中国生物制药将出售正大青岛67%股权给两位买方，交易总对价约为人民币18.2亿元。正大青岛主要从事骨质疏松症药物及海洋药物的研究开发、生产及销售。完成出售事项后，集团将继续持有正大青岛26%权益。2.海南深化医改十大创新举措公布。2月19日，2023年海南省深化医改十大创新举措向社会公布。2023年海南省深化医改十大创新举措是：打造三条“医疗主干道”，推进优质医疗资源逐级下沉取得新成效；全面推广“2﹢3”健康服务包，防治严重影响全省居民健康的5种疾病；以综合改革推进公立医院高质量发展；推动数字疗法从“政策高地”走向“应用高地”，推动医疗卫生服务提质增效降费；打造区域危急重症救治体系，建成“15分钟医疗急救圈”等。3.2024医药反腐强势来袭。2月18日，中纪委官方发布题为《牢牢扛起重点领域监督职责保障护航高质量发展》的头条文章指出：深化中央企业“靠企吃企”问题专项整治，是中央纪委国家监委指导国务院国资委推进的重点工作。文中点名，中国通用技术集团纪检监察组围绕药品、器械、耗材试剂“带金销售”等5个方面的34个“靠医吃医”“靠药吃药”问题推进整治。这是医药首次和金融、基建工程等腐败高发领域并称列举，意味着医药领域反腐工作已被提升到前所未有的高度。评审动态 1. CDE新药受理情况（02月09日) 2. FDA新药获批情况（北美02月16日）股市资讯上个交易日 A 股医药板块 +1.38%涨幅前三跌幅前三科源制药+20.01% 兴齐眼药-6.46%常山药业+19.86% 智翔金泰-3.61%大唐药业+16.33% 东方生物-1.96%【汇宇制药】全资子公司Seacross于近日收到埃及药品管理局核准签发的关于公司产品多西他赛注射液、注射用盐酸苯达莫斯汀、唑来膦酸注射液的上市许可。【人福医药】控股子公司宜昌人福药业有限责任公司近日收到国家药品监督管理局核准签发的注射用盐酸瑞芬太尼的《药品注册证书》。【复星医药】控股子公司重庆药友制药有限责任公司自主研发的氯化钾缓释片的药品注册申请于近日获国家药品监督管理局受理。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

孤儿药临床3期基因疗法快速通道上市批准

2024-02-19

·药明康德

速递 | 针对年轻人肾衰竭最常见原因！创新单抗获FDA突破性疗法认定

▎药明康德内容团队编辑日前，大冢制药（Otsuka Pharmaceutical）和Visterra公司宣布，美国FDA已授予其在研单抗sibeprenlimab（VIS649）突破性疗法认定（BTD），用于治疗免疫球蛋白A（IgA）肾病。IgA肾病是全世界原发性肾小球肾炎最常见的形式，也是年轻人肾衰竭的最常见原因之一。这次突破性疗法认定主要是基于ENVISION临床2期试验的积极结果，该结果在去年11月发表于《新英格兰医学杂志》上。研究结果表明，与安慰剂治疗相比，IgA肾病患者接受为期12个月的sibeprenlimab治疗后，蛋白尿状况显著减少。在第12个月时，与基线相比，接受2、4和8 mg/kg剂量的sibeprenlimab及安慰剂各组患者24小时尿蛋白/肌酐比值（UPCR）的几何平均比值降幅分别为47.2%、58.8%、62.0%和20.0%。与安慰剂组相比，sibeprenlimab组的估算肾小球滤过率（eGFR）也出现了有益的变化。接受2、4和8 mg/kg sibeprenlimab与安慰剂组患者的eGFR年变化分别为-2.7、+0.2、-1.5和-7.4 ml/min/1.73m2。这表明使用sibeprenlimab后患者的eGFR趋于稳定，反之使用安慰剂后，eGFR有所下降。图片来源：123RF在接受sibeprenlimab和安慰剂治疗的患者中，治疗伴发不良事件（TEAE）的发生率相似。在本试验及其后续至第16个月的随访期间，对sibeprenlimab的安全性评估中未发现不良毒性或临床意义上的免疫抑制证据。Sibeprenlimab是一种在研人源化单克隆抗体，它能阻断细胞因子A增殖诱导配体（APRIL）的作用。APRIL是一种免疫细胞生长因子，被认为在IgA肾病的发生和发展中起着关键作用。据公开资料显示，sibeprenlimab最初由Visterra公司开发。2018年，大冢制药宣布以约4.3亿美元的价格收购Visterra公司，从而获得包括sibeprenlimab在内一系列针对IgA肾病和其他肾脏疾病等适应症的在研产品。大家都在看▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] Sibeprenlimab Receives U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy. Retrieved February 19, 2024 from https://www.otsuka-us.com/news/sibeprenlimab-receives-us-fda-breakthrough-therapy-designation-treatment-immunoglobulin免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

突破性疗法临床结果临床2期并购临床1期

100 项与 Sibeprenlimab 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
免疫球蛋白a肾病	临床3期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2022-03-15

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04287985 (VIS649-201, Pubmed \| NEWS \| Br Dent J) 人工标引	临床2期	免疫球蛋白a肾病	155	sibeprenlimab	積醖醖膚醖艱願夢鑰餘(廠積膚鏇鹹製齋糧鹹廠) = 顧鑰膚糧顧觸鑰簾網鹽範鏇窪築糧醖積遞遞齋 (鬱淵鏇餘憲網齋簾廠夢, 8.2) 更多	-	2023-11-02
				sibeprenlimab	積醖醖膚醖艱願夢鑰餘(廠積膚鏇鹹製齋糧鹹廠) = 鹽夢鬱鑰艱鹽鏇遞夢製範鏇窪築糧醖積遞遞齋 (鬱淵鏇餘憲網齋簾廠夢, 6.1) 更多
NCT03719443 (ERA2021) 人工标引	临床1期	白喉 \| 破伤风	14	VIS649	簾願蓋繭築壓鏇壓製顧(壓鹹繭鏇積構壓繭蓋製) = 遞鏇窪糧夢糧廠淵獵醖構衊蓋鏇淵艱鑰醖鹹衊 (淵獵繭鹹鏇膚顧簾蓋選 ) 更多	积极	2021-09-17
				Placebo	簾願蓋繭築壓鏇壓製顧(壓鹹繭鏇積構壓繭蓋製) = 壓鹽繭齋壓願選範衊餘構衊蓋鏇淵艱鑰醖鹹衊 (淵獵繭鹹鏇膚顧簾蓋選 ) 更多
NCT03719443 (VIS649, ERA2021)	临床1期	-	15	VIS649 6.0 mg/kg	網艱鏇鬱衊壓齋繭窪淵(餘齋願淵願憲淵衊鏇選) = 遞齋願獵蓋構襯窪鹽衊獵獵遞襯壓糧遞獵齋願 (壓憲鹹膚餘觸鑰選積廠 )	积极	2021-05-29
				Placebo	網艱鏇鬱衊壓齋繭窪淵(餘齋願淵願憲淵衊鏇選) = 鏇構醖廠構簾構選觸鏇獵獵遞襯壓糧遞獵齋願 (壓憲鹹膚餘觸鑰選積廠 )
VIS649 (ASN2018)	N/A	免疫球蛋白a肾病 APRIL	-	VIS649 Batch 1	壓製衊鑰廠選顧艱簾衊(窪築憲餘鑰構鬱繭遞遞) = Observed minor changes in glycans were not found to impact in vivo or in vitro VIS649 activity 鹽獵觸壓觸醖膚齋廠艱 (餘鏇鏇顧蓋顧壓簾選夢 )	积极	2018-10-23
				VIS649 Batch 2
VIS649 (ASN2017)	N/A	免疫球蛋白a肾病 IgA \| IgG \| IgM	4	VIS649 25 mg/kg	襯衊齋醖鹹築餘膚鏇遞(觸簾範鏇願蓋壓構齋餘) = 製構遞膚憲蓋遞願齋淵繭願糧鏇簾觸築蓋鹽簾 (鬱餘鏇鹽顧顧鏇夢鬱顧 )	积极	2017-10-31