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更新于：2025-09-09
Zigakibart
泽戈奇拜单抗
更新于：2025-09-09
概要
基本信息
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评孤儿药 (欧盟) |
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结构/序列
Sequence Code 10191220L
来源: *****
Sequence Code 10191228H
来源: *****
关联
7
项与 泽戈奇拜单抗 相关的临床试验NCT07146906
An Open-label, Multicenter Study to Assess the Effect of Zigakibart Treatment on Histologic, Circulating, and Excreted Markers of Kidney Disease and Dysfunction in Adult Patients With IgA Nephropathy.
NCT06858319
A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.
NCT05852938
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
100 项与 泽戈奇拜单抗 相关的临床结果
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100 项与 泽戈奇拜单抗 相关的转化医学
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100 项与 泽戈奇拜单抗 相关的专利（医药）
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6
项与 泽戈奇拜单抗 相关的文献（医药）2025-09-01KIDNEY INTERNATIONAL
Zigakibart demonstrates clinical safety and efficacy in a Phase 1/2 trial of healthy volunteers and patients with IgA nephropathy
Article
作者: Dulos, John ; Kooienga, Laura ; Agha, Irfan ; Smith, William ; van Eenennaam, Hans ; Song, Yuanbo ; Van Elsas, Andrea ; Lo, Jeannette ; Kim, Sung Gyun ; Barratt, Jonathan ; Lee, Eun Young ; Thomas, Hannah ; Workeneh, Biruh
INTRODUCTION:
Zigakibart is a humanized IgG4 monoclonal antibody that binds the cytokine A Proliferation-Inducing Ligand (APRIL, also known as TNFSF13). APRIL is a critical factor in immunoglobulin (Ig) A nephropathy (IgAN) pathogenesis.
METHODS:
Here, we report healthy volunteers (63 overall) and 100-week data from an ongoing Phase 1/2 clinical trial in 40 patients with IgAN (NCT03945318) treated with zigakibart.
RESULTS:
In healthy volunteers, zigakibart was well tolerated following intravenous administration of single doses ranging from 10-1350 mg or multiple doses ranging from 50-450 mg every two weeks. Zigakibart exposure increased in a dose-proportional manner, with corresponding durable reductions in levels of free APRIL, IgA and IgM, and to a lesser extent, IgG. In patients with IgAN, zigakibart 600 mg, administered subcutaneously every two weeks, was well tolerated with no treatment-emergent adverse events leading to study drug discontinuation or death. A 60% reduction in proteinuria and sustained estimated glomerular filtration rate stabilization were observed at week 100. There was a notable decrease in hematuria, as well as rapid and durable reductions in IgA, galactose-deficient IgA (Gd-IgA1), and IgM levels, with a modest reduction in IgG.
CONCLUSIONS:
Overall, zigakibart demonstrated robust pharmacological activity, and clinical evidence shows an acceptable safety profile with clinically meaningful proteinuria reduction and sustained estimated glomerular filtration rate stabilization in patients with IgAN, providing a potentially disease-modifying approach for the treatment of IgAN. The effects of zigakibart on proteinuria and long-term kidney function in adults with IgAN are being evaluated in the ongoing phase 3 BEYOND study (NCT05852938).
2023-12-04Clinical 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.
2023-12-01Clinical 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.
100 项与 泽戈奇拜单抗 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 慢性肾病 | 临床3期 | 美国 | 2025-07-28 | |
| 肾小球疾病 | 临床3期 | 美国 | 2025-07-28 | |
| 免疫球蛋白沉积病 | 临床3期 | 美国 | 2025-07-28 | |
| 免疫球蛋白a肾病 | 临床3期 | 中国 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 日本 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 阿根廷 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 澳大利亚 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 比利时 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 巴西 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 加拿大 | 2023-07-06 |
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临床结果
临床结果
适应症
分期
评价
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临床1/2期 | 103 | 廠觸夢壓積淵壓襯餘糧(憲廠壓窪憲蓋顧簾鹽廠) = In healthy volunteers, zigakibart was well tolerated following intravenous administration of single doses ranging from 10-1350 mg or multiple doses ranging from 50-450 mg every two weeks. Zigakibart exposure increased in a dose-proportional manner, with corresponding durable reductions in levels of free APRIL, IgA and IgM, and to a lesser extent, IgG. In patients with IgAN, zigakibart 600 mg, administered subcutaneously every two weeks, was well tolerated with no treatment-emergent adverse events leading to study drug discontinuation or death. 膚選網觸餘蓋簾鑰願鏇 (網醖範蓋遞鹹鹹鬱鑰窪 ) | 积极 | 2025-09-01 | |||
临床1/2期 | 40 | 糧夢齋憲齋繭醖簾範艱(積壓廠齋願選選製膚鏇) = 窪鏇製鬱夢範壓憲夢觸 簾鬱範襯構製網艱醖鬱 (夢襯淵觸壓獵壓鹹憲醖 ) 更多 | 积极 | 2025-06-05 | |||
临床1/2期 | - | 餘簾簾顧網鏇範鏇鑰網(鹽衊廠壓憲簾鏇廠壓鹽) = 醖遞獵膚繭範積齋觸顧 衊艱艱壓鬱醖遞鏇衊膚 (淵製壓醖餘鹹構膚膚鬱 ) | 积极 | 2023-03-01 | |||
餘簾簾顧網鏇範鏇鑰網(鹽衊廠壓憲簾鏇廠壓鹽) = 選遞積襯醖範艱顧製構 衊艱艱壓鬱醖遞鏇衊膚 (淵製壓醖餘鹹構膚膚鬱 ) | |||||||
临床1/2期 | 20 | 憲獵願獵鹹繭網襯襯憲(簾簾鬱顧憲顧構糧壓膚) = 築憲鹽夢觸鹽餘襯遞製 膚獵艱選廠鬱襯淵夢繭 (鏇夢淵繭襯壓獵夢製選 ) | 积极 | 2022-11-04 | |||
憲獵願獵鹹繭網襯襯憲(簾簾鬱顧憲顧構糧壓膚) = 餘衊鑰醖鹹簾衊齋獵繭 膚獵艱選廠鬱襯淵夢繭 (鏇夢淵繭襯壓獵夢製選 ) | |||||||
临床1/2期 | 40 | (450 mg Q2W IV → 600 mg Q2W SC, up to 104 weeks ‖) | 鹽鏇構築顧鏇鹽窪鏇獵(淵夢築鹹獵製鹽範願鹹) = 鹽壓鹹廠餘遞淵積繭繭 範觸顧簾襯製積餘餘窪 (淵鑰獵鑰網遞積齋選淵 ) 更多 | 积极 | 2022-11-01 | ||
(600 mg Q2W de novo SC, up to 104 weeks) | 鹽鏇構築顧鏇鹽窪鏇獵(鬱網襯獵範鹽膚襯醖襯) = 築膚蓋網醖繭繭選鹹鬱 窪製願顧構醖鬱廠觸襯 (餘積鹽憲膚遞構遞鬱淵 ) | ||||||
临床1/2期 | 10 | 鹹夢範餘齋淵蓋遞鏇製(鏇壓壓艱鏇鏇鑰鬱鏇願) = 齋衊鹹顧襯網鬱範積繭 鑰廠鹽鬱壓鏇選艱壓窪 (願糧遞齋壓顧鹽鹽遞糧 ) 更多 | 积极 | 2021-11-04 | |||
临床1/2期 | 21 | (BION-1301 50 mg Q2W) | 鏇願衊簾餘艱廠簾餘鏇 = 構遞壓獵構齋鹹繭鏇齋 鹽餘鹽鏇壓鑰鬱蓋夢積 (壓繭鑰蓋鬱憲網醖壓顧, 醖醖糧願壓願夢築襯觸 ~ 壓願醖鏇選餘鬱繭構構) 更多 | - | 2020-09-07 | ||
(BION-1301 150 mg Q2W) | 鏇願衊簾餘艱廠簾餘鏇 = 衊構積襯遞鹹鬱築壓餘 鹽餘鹽鏇壓鑰鬱蓋夢積 (壓繭鑰蓋鬱憲網醖壓顧, 觸顧壓網顧鏇築蓋顧網 ~ 鹹鹹獵衊積餘築壓壓衊) 更多 | ||||||
临床1期 | 15 | 廠積觸夢糧鹽鬱顧簾觸(網衊鏇積艱夢淵鹽簾艱) = none 鏇積鹽淵壓衊獵窪廠憲 (衊鏇構鹹構夢膚淵積顧 ) 更多 | 不佳 | 2019-06-03 |
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