The purpose of this study is to collect long-term safety and tolerability data for atacicept in patients with IgAN that completed Vera trial investigating atacicept in IgAN population.

开始日期2024-12-01

申办/合作机构

Vera Therapeutics, Inc.

SLCTR/2023/021

/ Suspended临床3期

A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN)

开始日期2023-11-15

申办/合作机构

Vera Therapeutics, Inc.

NCT04716231

/ Recruiting临床3期

A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN)

A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)

开始日期2023-05-23

申办/合作机构

Vera Therapeutics, Inc.

100 项与阿塞西普相关的临床结果

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100 项与阿塞西普相关的转化医学

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100 项与阿塞西普相关的专利（医药）

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132

项与阿塞西普相关的文献（医药）

2024-12-19·Iranian journal of kidney diseases

TACI Ig Fusion Protein Inhibits TLR4/MyD88/NF-κB Pathway Alleviates Renal Injury in IgA Nephropathy Rats.

Article

作者: Chen, Xinnan ; Li, Zengyan ; Chen, Peng ; Zhang, Wei ; Sun, Jianhua ; Cheng, Yue ; Wang, Caili

INTRODUCTIONTo evaluate the impact of TACI fusion protein (TACI-Ig) on IgA nephropathy (IgAN) in rats, and to explore its mechanism and relationship with TLR4/MyD88/NF-κB pathway.METHODSprague Dawley(SD)rats were divided into six groups: control, model, TACI-Ig low dose (TACI-Ig-L), medium dose (TACI-Ig-M), high dose (TACI-Ig-H), and prednisone acetate (PAT) group. The control group and model group received physiological saline injections, while the TACI-Ig groups were administered doses of 7.18, 14.36, and 28.72 mg/kg of TACI-Ig, respectively. PAT group was pretreated with prednisone acetate. After 8 weeks, kidney weight/body weight ratios, 24-hour urine protein (24 h UP), serum creatinine (SCr), and blood urea nitrogen (BUN) levels were measured. Additionally, concentrations of B cell activating factor (BAFF), APRIL, and Gd-IgA1 were evaluated by using ELISA. Pathological changes in kidney tissues were scored, and TLR4, MyD88, NF-κB expression levels were detected through western blot (WB) and RT-qPCR. Results. Renal function assessments showed that the IgAN model group exhibited increased in 24 h UP, SCr, BUN, and elevated serum levels of BAFF, APRIL, Gd-IgA1, alongside higher TLR4/MyD88/NF-κB protein expression. TACI-Ig treatment significantly reduced proteinuria, SCr, BUN, levels of BAFF, APRIL, and Gd-IgA1 in IgAN rats. Pathologically, TACI-Ig ameliorated glomerular mesangial deposition and fibrosis. It also inhibited TLR4/MyD88/NF-κB protein expression, demonstrating anti-inflammatory and immune regulatory effects.CONCLUSIONSTACI-Ig mitigates renal injury in IgAN rats by reducing inflammatory infiltration and IgA deposition and suppressing the pathway of TLR4/MyD88/NF-κB, offering data for developing effective treatments for IgAN.

2024-11-01·International Journal of Clinical Oncology

Current status of BAFF targeting immunotherapy in B-cell neoplasm

Review

作者: Tagami, Nami ; Goto, Yasuyuki ; Yuda, Junichiro

AbstractB-cell activating factor belonging to the TNF family (BAFF), also known as B-lymphocyte stimulator (BLyS), plays a crucial role in B-cell development. It has multiple receptors, including BCMA, TACI, and BAFF-R, with diverse roles in different cell types. BAFF induces B-cell proliferation and immunoglobulin secretion, and acts as a survival factor for immature, naive, and activated B cells. Consequently, BAFF-deficient mice often show suppressed humoral responses, while BAFF-overexpressing mice show the higher number of mature B cells and may develop autoimmune-like manifestations and B-cell lymphoproliferative diseases. Elevated BAFF levels are also associated with various hematological malignancies, and its expression correlates with disease progression in some cases. Therefore, BAFF-targeted therapies, such as belimumab, atacicept, and tabalumab, are being explored in clinical trials for conditions like chronic lymphocytic leukemia (CLL) and multiple myeloma. Belimumab, an anti-BAFF monoclonal antibody, is being investigated in combination with rituximab/venetoclax for CLL. Atacicept, a decoy receptor for BAFF and APRIL, showed tolerability in a phase 1b trial for CLL. Tabalumab, another monoclonal antibody targeting BAFF, did not demonstrate significant efficacy in a phase 2 study for relapsed/refractory multiple myeloma. BAFF ligand-based CAR-T cells are designed to target BAFF receptors and show promise in preclinical studies, particularly for B-cell malignancies. The review emphasizes the importance of understanding the roles of BAFF and its receptors in the microenvironment of hematologic malignancies. Targeting BAFF and its receptors presents potential therapeutic avenues, and ongoing clinical trials provide valuable insights.

2024-06-01·Kidney International

A phase 2b, randomized, double-blind, placebo-controlled, clinical trial of atacicept for treatment of IgA nephropathy

Article

作者: Jha, Vivekanand ; Lafayette, Richard ; Maes, Bart ; Tesař, Vladimír ; Barratt, Jonathan ; Kim, Sung Gyun ; Israni, Rubeen ; Floege, Jürgen ; Wei, Xuelian ; Singh, Harmeet ; Eren, Necmi ; Barbour, Sean ; Lin, Celia J F ; Phoon, Richard K S

Atacicept is a first-in-class, dual anti-B-cell Activation Factor-A Proliferation-Inducing Ligand fusion protein in clinical evaluation for treatment of IgA nephropathy. To compare efficacy and safety of atacicept versus placebo in patients with IgAN, this randomized, double-blind, placebo-controlled phase 2b clinical trial ORIGIN enrolled 116 individuals with biopsy-proven IgA nephropathy. Participants were randomized to atacicept 150, 75, or 25 mg versus placebo once weekly for up to 36 weeks. Primary and key secondary endpoints were changes in urine protein creatinine ratio based on 24-hour urine collection at weeks 24 and 36, respectively, in the combined atacicept 150 mg and 75 mg group versus placebo. The primary endpoint was met at week 24 as the mean urine protein creatinine ratio was reduced from baseline by 31% in the combined atacicept group versus 8% with placebo, resulting in a significant 25% reduction with atacicept versus placebo. At week 36, the key secondary endpoint was met as the mean urine protein creatinine ratio reduced from baseline by 34% in the combined atacicept group versus a 2% increase with placebo, resulting in a significant 35% reduction with atacicept versus placebo. The reduction in proteinuria was accompanied by stabilization in endpoint eGFR with atacicept compared to a decline with placebo at week 36, resulting in significant between-group geometric mean difference of 11%, approximating an absolute difference of 5.7 mL/min/1.73m². Endpoint galactose deficient IgA1 levels significantly decreased from baseline by 60% versus placebo. The safety profile of atacicept was like placebo. Thus, our results provide evidence to support a pivotal, phase 3 study of atacicept in IgA nephropathy.

108

项与阿塞西普相关的新闻（医药）

2025-01-14

·GlobeNewswire-Health Care

Vera Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BRISBANE, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that on January 8, 2025, the Compensation Committee granted inducement awards consisting of a non-qualified stock option to purchase 35,250 shares of Class A common stock and restricted stock units (RSUs) for 17,625 shares of Class A common stock to six new employees under the Inducement Plan. The Compensation Committee approved the awards as an inducement material to the new employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4). Each stock option granted on January 8, 2025 has an exercise price per share equal to $42.19, Vera’s closing trading price on January 8, 2025. Each stock option will vest over four years, with 25% of the underlying shares vesting on the first anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee’s continued service relationship with Vera through the applicable vesting dates. Each of the RSUs will vest over four years, with 25% of the underlying shares vesting on each anniversary of February 20, 2025, subject to the new employee’s continued service relationship with Vera through the applicable vesting dates. The awards are subject to the terms and conditions of the Inducement Plan and the terms and conditions of an applicable award agreement covering the grant. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit www.veratx.com. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com

免疫疗法临床结果

2025-01-13

·GlobeNewswire-Health Care

Vera Therapeutics Acquires Global Rights to Novel, Next Generation Dual BAFF/APRIL Inhibitor

BRISBANE, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. “This novel approach is part of Vera’s broad lifecycle management strategy to expand and extend our leadership position within B cell modulation, which we believe has the potential to transform how we treat patients suffering from a variety of B cell mediated diseases. We plan to leverage our research, translational medicine, clinical development and commercial expertise to define and advance the potential of this molecule,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “This transaction furthers our commitment to transforming outcomes for patients with grievous autoimmune diseases.” This agreement will enable Vera to develop and market VT-109 in return for undisclosed upfront and milestone payments. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit www.veratx.com Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, VT-109’s potential to transform how patients suffering from B cell mediated diseases are treated and Vera’s plans to advance development of VT-109. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believe,” “plan,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com

引进/卖出免疫疗法

2025-01-02

·药明康德

2025上半年值得关注的十大临床试验

▎药明康德内容团队编辑随着生物技术领域不断实现突破性进展，医药行业对2025年可能涌现的医学创新充满期待。今日，行业媒体BioPharma Dive发布了一篇文章，从诸多前景广阔的研发项目中挑选出了10项有可能在今年上半年对整个行业产生显著影响的临床试验进行了专题报道。这些试验覆盖了广泛的研发领域，它们不仅代表了医药研发的最新成就，更有望为全球患者带来生命的转机。在本文中，药明康德内容团队将结合公开资料，与读者分享这些值得关注的临床试验。图片来源：123RF 药物名称：Tirzepatide 适应症：2型糖尿病相关心血管疾病开发公司：礼来（Eli Lilly and Company）临床试验：Surpass-CVOT（NCT04255433）该试验旨在评估GIP/GLP-1受体双重激动剂tirzepatide与GLP-1受体激动剂dulaglutide在2型糖尿病并伴有心血管风险增加的患者中的疗效和安全性。与其他将药物与安慰剂进行对比的类似研究不同，礼来选择将tirzepatide与其另一款糖尿病药物dulaglutide进行直接的比较，后者本身在改善心血管健康方面已显示出疗效。根据ClinicalTrials.gov，该试验招募超过1.3万名患者，其初步结果最早可能在今年6月发布。试验主要结果为患者从随机化到研究完成期间（约54个月），首次心血管相关死亡、心肌梗死（MI）或卒中（MACE-3）的发生时间。该试验数据还可能揭示礼来公司肥胖药物Zepbound在其试验中的潜在表现。Zepbound的主要活性成分也是tirzepatide，礼来目前正在研究其是否可以预防更广泛的心血管相关并发症以及任何原因导致的死亡。该研究初步数据预计将在2027年完成。药物名称：Vepdegestrant（ARV-471，PF-07850327）适应症：晚期乳腺癌开发公司：Arvinas和辉瑞（Pfizer）临床试验：Veritac-2（NCT05654623） Vepdegestrant是一种具有口服生物利用度的在研蛋白降解剂，旨在靶向降解雌激素受体。Veritac-2临床3期试验旨在评估该药物与获批、注射给药的雌激素受体降解剂氟维司群（fulvestrant）相较，在晚期ER+/HER2-乳腺癌患者中的安全性和疗效。该试验共招募624位患者，初步结果预计在今年第一季度公布。根据公司之前的新闻稿，vepdegestrant有望成为首款蛋白降解靶向嵌合体（PROTAC）疗法。当前，vepdegestrant正在进行两项3期临床试验，同时计划再开展两项试验。上个月，vepdegestrant与CDK4/6抑制剂abemaciclib联合，用以治疗局部晚期或转移性ER+/HER2-乳腺癌患者1b期临床试验TACTIVE-U子研究的结果公布。分析显示，abemaciclib与3期临床试验推荐剂量（200 mg，每日一次）vepdegestrant联用具有可接受的安全性，患者临床获益率达到62.5%。药物名称：Atacicept 适应症：IgA肾病（IgAN）开发公司：Vera Therapeutics 临床试验：ORIGIN 3（NCT04716231） IgA肾病是一种会逐渐损害肾功能的疾病。尽管目前已有多种治疗方案获批，但它们并不能完全阻止患者肾功能的恶化。Atacicept是一种重组融合蛋白，含有可溶性跨膜激活剂和钙调亲环素配体相互作用因子（TACI）受体，可以与细胞因子B淋巴细胞刺激因子（BLyS）和增殖诱导配体（APRIL）结合。这些因子会刺激有害自身抗体的产生。之前公布的2期临床试验结果显示，在96周的长期随访中，atacicept组患者肾功能持久维持稳定，显示该药物在改变IgAN患者疾病自然进程和预防肾功能衰竭方面的潜力。行业媒体Fierce Biotech指出，该药物显著的持久疗效接近达成肾病“功能性治愈”的目标。目前进行中的ORIGIN 3临床3期试验已招募376名患者，试验的顶线结果预计在2025年第二季度公布，该结果可能为atacicept的上市申请提供支持。药物名称：Pelacarsen（TQJ230）适应症：心血管疾病（CVD）开发公司：诺华（Novartis）、Ionis Pharmaceuticals 临床试验：Lp（a）Horizon（NCT04023552） Pelacarsen是一款针对脂蛋白（a）——Lp（a）驱动CVD患者的反义寡核苷酸（ASO）疗法，由诺华与Ionis Pharmaceuticals共同合作开发。Lp（a）Horizon临床3期试验的结果可能为Lp（a）是否会像低密度脂蛋白胆固醇（LDL-C）和甘油三酯一样，成为心血管风险治疗清单上的重要项目提供解答。该试验正在对超过8000名确诊具有心血管疾病且Lp（a）水平升高的患者进行评估，其目标是深入探讨降低Lp（a）是否可以减少心脏病发作和中风等主要心血管事件的发生，试验预计在2025年5月底完成。如果试验结果积极，诺华可能递交pelacarsen的上市许可申请。药物名称：MORF-057 适应症：溃疡性结肠炎（UC）开发公司：礼来临床试验：Emerald-2（NCT05611671）去年7月，礼来以总额约32亿美元的款项收购Morphic Holding，并获得其主打项目MORF-057用以治疗炎症性肠病（IBD）。这是一款选择性口服小分子α4β7整合素抑制剂，旨在阻止淋巴细胞表面的α4β7整合素与粘膜内皮细胞配体MAdCAM-1之间的相互作用，大幅减少淋巴细胞从血流进入肠粘膜组织的迁移，并避免与IBD相关的炎症。 EMERALD-2是一项2b期随机、双盲、安慰剂对照研究，旨在评估三种MORF-057活性剂量方案在中度至重度活动性UC成年患者中的安全性和疗效。根据BioPharma Dive的报道，该试验初步结果可能在2025年上半年公布，而试验的积极结果可能推动免疫相关疾病治疗方式的转变，这类疾病传统上主要依赖注射药物进行治疗。药物名称：司美格鲁肽（semaglutide）适应症：阿尔茨海默病（AD）开发公司：诺和诺德（Novo Nordisk）临床试验：Evoke（NCT04777396） EVOKE是一项随机双盲、安慰剂对照的3期试验，共有1840名患有轻度认知障碍或AD类型的轻度痴呆患者入组，旨在评估每日一次口服司美格鲁肽对早期AD患者是否具有积极作用。如果该试验结果积极，可能会驱使研究人员思考肠道激素如何影响大脑，并可能改变阿尔茨海默病的治疗方式。根据ClinicalTrials.gov网站，该试验初步结果预计在今年9月公布，但部分分析师认为诺和诺德可能提早在今年上半年公布结果。药物名称：BEAM-302 适应症：α1抗胰蛋白酶缺乏症（AATD）开发公司：Beam Therapeutics 临床试验：NCT06389877 Beam-302是一款修复α1抗胰蛋白酶缺乏症致病突变的体内基因编辑疗法。AATD是一种可影响肺和肝脏功能的遗传疾病，由于缺乏具有正常功能的α-1抗胰蛋白酶，新生儿可能出现肝炎综合征，成年人则可能出现肝纤维化，甚至发展为肝硬化和肝细胞癌。这项正在进行的1/2期、多中心、开放标签、剂量探索（1期）和剂量扩展（2期）研究，旨在评估BEAM-302对患有AATD相关肺病和/或肝病的成年患者中的安全性、耐受性、药代动力学（PK）/药效学（PD）和疗效，并确定最佳生物剂量（OBD），该试验目前已招募106位患者。药物名称：COMP360 适应症：难治性抑郁症（TRD）开发公司：Compass Pathways 临床试验：NCT05624268 抑郁症（MDD）是增长最快的精神健康疾病之一，全球有超过3.2亿人患有抑郁症。然而，这些患者中约有三分之一（1亿人）无法从现有疗法中获得帮助，患有难治性抑郁症。与非TRD的MDD患者相比，TRD患者的全因死亡率更高。裸盖菇素（psilocybin）是源于毒蘑菇中的致幻活性成分，能够作用于大脑中的血清素2a受体。此前，多项学术研究证明了裸盖菇素在抑郁症和焦虑症中具有治疗潜力，结合心理支持，可以在单次高剂量给药之后快速减轻患者的抑郁症状。 COMP360是COMPASS Pathways专有的稳定、高纯度、多晶型合成的裸盖菇素制剂，于2018年获得了美国FDA授予的突破性疗法认定，用于治疗TRD。这项正在进行中的随机双盲、安慰剂对照的3期试验已招募255名TRD患者，该试验的初步结果预计在2025年2月公布。药物名称：VX-522 适应症：囊性纤维化（CF）开发公司：Moderna与Vertex Pharmaceuticals 临床试验：NCT05668741 VX-522是Vertex公司与Moderna于2016年签订的独家研究合作的成果。该mRNA疗法把全长囊性纤维化跨膜传导调节因子（CFTR） mRNA封装在脂质纳米颗粒（LNP）中，通过吸入的方式输送到肺部。一旦递送到气道中的靶细胞，mRNA就能够产生功能性的CFTR蛋白。CFTR蛋白在数量和功能上的改善可以为CF患者带来变革性的益处。这项临床1/2期试验的目的是评估VX-522对18岁及以上患有囊性纤维化和对CFTR调节剂疗法不产生应答患者的安全性、耐受性和有效性，试验结果预定在今年3月公布。该疗法有望为全球约5000名无法从CFTR调节剂中获益的CF患者提供治疗选择。药物名称：VERVE-102 适应症：家族性高胆固醇血症（HeFH）与早发性冠状动脉疾病（CAD）开发公司：Verve Therapeutics 临床试验：VT-10201（NCT06164730） VT-10201是一项开放标签、单次递增剂量1b期研究，旨在评估单碱基编辑疗法VERVE-102对杂合体家族性高胆固醇血症或早发性冠状动脉疾病患者给药的安全性，这些患者需要进一步降低其LDL-C水平。VERVE-102旨在破坏肝脏中PCSK9基因的表达并降低血液循环中的PCSK9和LDL-C水平。本研究旨在确定VERVE-102在该患者群体中的安全性和药效学特征。 Verve所开发的另一款PCSK9靶向单碱基编辑疗法VERVE-101已在2023年11月完成人体概念验证。分析显示，该疗法的最高剂量可以通过一次治疗，将患者的LDL-C水平降低55%，并持续长达180天以上。VERVE-101和VERVE-102都使用相同的PCSK9靶向碱基编辑器，但VERVE-102采用了Verve专有的GalNAc-LNP递送技术。Verve预计根据临床试验结果在VERVE-101与VERVE-102之间选择一个进入2期临床试验。 ▲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] 10 clinical trials to watch in the first half of 2025. Retrieved January 2, 2025 from https://www.biopharmadive.com/news/biotech-pharma-clinical-trials-watch-2025/736120/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202025-01-02%20BioPharma%20Dive%20%5Bissue:69101%5D&utm_term=BioPharma%20Dive [2] A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes (SURPASS-CVOT). Retrieved January 2, 2025 from https://clinicaltrials.gov/study/NCT04255433?term=Surpass-CVOT%20&rank=1 [3] A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer (VERITAC-2). Retrieved January 2, 2025 from https://clinicaltrials.gov/study/NCT05654623?term=Veritac-2%20&rank=1 [4] Atacicept in Subjects with IgA Nephropathy (ORIGIN 3). Retrieved January 2, 2025 from https://clinicaltrials.gov/study/NCT04716231?term=Origin%203%20&intr=atacicept&rank=1 [5] Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD (Lp(a)HORIZON). Retrieved January 2, 2025 from https://clinicaltrials.gov/study/NCT04023552 [6] A Study to Evaluate MORF-057 in Adults with Moderately to Severely Active UC (EMERALD-2). Retrieved January 2, 2025 from https://clinicaltrials.gov/study/NCT05611671 [7] A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE). Retrieved January 2, 2025 from https://clinicaltrials.gov/study/NCT04777396 [8] A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients with Alpha-1 Antitrypsin Deficiency (AATD). Retrieved January 2, 2025 from https://clinicaltrials.gov/study/NCT06389877 [9] Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD. Retrieved January 2, 2025 from https://clinicaltrials.gov/study/NCT05624268 [10] A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF). Retrieved January 2, 2025 from https://clinicaltrials.gov/study/NCT05668741 [11] A Study of VERVE-102 in Patients with Familial Hypercholesterolemia or Premature Coronary Artery Disease. Retrieved January 2, 2025 from https://clinicaltrials.gov/study/NCT06164730 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

临床结果临床3期蛋白降解靶向嵌合体临床2期

100 项与阿塞西普相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09704	阿塞西普	-	DB06399

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
系统性红斑狼疮	临床3期	-	Merck Serono SA	-
系统性红斑狼疮	临床3期	-	ZymoGenetics, Inc.	-
狼疮性肾炎	临床2期	美国	EMD Serono, Inc.	2007-12-01
狼疮性肾炎	临床2期	新加坡	ZymoGenetics, Inc.	2007-12-01
狼疮性肾炎	临床2期	中国台湾	EMD Serono, Inc.	2007-12-01
狼疮性肾炎	临床2期	捷克	ZymoGenetics, Inc.	2007-12-01
狼疮性肾炎	临床前	美国	EMD Serono, Inc.	2007-12-01
狼疮性肾炎	临床前	捷克	ZymoGenetics, Inc.	2007-12-01
狼疮性肾炎	临床前	新加坡	ZymoGenetics, Inc.	2007-12-01
狼疮性肾炎	临床前	中国台湾	EMD Serono, Inc.	2007-12-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04716231 (ORIGIN, GlobeNewswire) 人工标引	临床2期	免疫球蛋白a肾病	116	Atacicept	醖壓壓窪獵範餘鏇範積(襯壓鹹淵遞醖顧願製廠) = 齋窪糧積齋鏇鏇築糧齋蓋膚遞願遞築醖淵壓積 (網積鬱顧艱糧獵築艱窪 ) 更多	积极	2024-10-26
				Placebo	-
ISN WCN2024	N/A	免疫球蛋白a肾病	-	Atacicept 150 mg	糧鬱醖築築顧築築壓夢(廠積獵壓夢選衊選鹹積) = 蓋艱窪淵憲蓋積遞選鏇鏇壓範窪繭鏇夢襯獵膚 (齋鏇蓋窪築醖顧鹽遞鏇 ) 更多	-	2024-04-01
				Placebo	鹽選艱獵願齋觸鹹遞鏇(窪網糧顧衊餘廠積膚構) = 選繭壓鹹衊積遞憲範糧壓窪製壓鏇醖襯範繭鹹 (艱網膚壓網築遞鑰觸積 )
ISN WCN2024	N/A	免疫球蛋白a肾病	-	Atacicept 150 mg	築憲艱積餘鏇憲淵選憲(醖繭遞獵蓋廠糧鏇獵遞) = 獵構鏇淵鹹選鬱艱構構願鹹鬱願鹹選淵選鑰淵 (簾顧簾廠夢願選蓋鹽願 )	-	2024-04-01
				Placebo	築憲艱積餘鏇憲淵選憲(醖繭遞獵蓋廠糧鏇獵遞) = 鏇積製鏇壓願顧夢構齋願鹹鬱願鹹選淵選鑰淵 (簾顧簾廠夢願選蓋鹽願 )
NCT04716231 (ORIGIN, Literature) 人工标引	临床2期	免疫球蛋白a肾病	116	atacicept 25 mg	(齋願製積鏇鏇齋遞鏇餘) = similar across the atacicept dose groups and placebo. 鹽憲簾觸網選齋簾鑰窪 (網構夢鏇鏇繭糧構廠觸 )	积极	2024-03-27
				atacicept 75 mg
NCT04716231 (ORIGIN, GlobeNewswire) 人工标引	临床2期	免疫球蛋白a肾病	-	Atacicept	(簾夢衊顧網壓艱壓衊艱) = met its primary endpoint 膚願鏇構構膚願醖淵願 (齋醖鏇獵襯襯蓋醖鹹廠 ) 达到更多	积极	2024-01-08
				Placebo
NCT04716231 (ORIGIN \| JANUS, GlobeNewswire) 人工标引	临床2期	免疫球蛋白a肾病	-	atacicept (JANUS)	(積製糧遞餘獵壓構窪積) = Through the randomized, placebo-controlled period, infections were balanced between atacicept and placebo in both the Phase 2a JANUS and Phase 2b ORIGIN studies. 餘遞鏇襯積鏇窪繭觸鹹 (範鏇襯構遞製齋獵繭選 )	积极	2023-11-04
				placebo (JANUS)
NCT02808429 (Phase II study, CTgov)	临床2期	免疫球蛋白a肾病	16	Placebo (Placebo)	窪窪醖齋醖壓夢窪艱築(壓憲網築網餘膚夢鹽餘) = 積構襯淵憲繭窪淵鑰壓繭壓觸鏇壓製齋遞構鑰 (蓋獵鑰淵繭遞觸獵膚鏇, 積願觸鑰餘餘蓋壓觸艱 ~ 選簾淵膚顧鑰鬱窪壓鹹) 更多	-	2021-02-25
				Atacicept 25 mg (Atacicept 25 mg)	窪窪醖齋醖壓夢窪艱築(壓憲網築網餘膚夢鹽餘) = 艱廠憲醖齋廠壓醖壓餘繭壓觸鏇壓製齋遞構鑰 (蓋獵鑰淵繭遞觸獵膚鏇, 製鑰積簾鏇窪壓憲醖艱 ~ 窪廠夢獵顧鹹艱製膚鹽) 更多
NCT02808429 (Phase II study, ERA2020)	临床2期	蛋白尿 \| 免疫球蛋白a肾病 Gd-IgA1	-	Placebo	廠襯憲憲壓衊淵鏇糧範(鹽艱鹽窪選鬱襯遞繭願) = 簾膚願鏇遞鹽壓壓鹽簾蓋鏇夢選壓膚艱選壓餘 (鬱窪鏇鬱獵夢鏇窪糧糧 )	积极	2020-06-06
				Atacicept 25mg	廠襯憲憲壓衊淵鏇糧範(鹽艱鹽窪選鬱襯遞繭願) = 繭糧憲餘蓋獵鬱積鏇願蓋鏇夢選壓膚艱選壓餘 (鬱窪鏇鬱獵夢鏇窪糧糧 )
NCT01972568 (ADDRESS II, Pubmed \| Rheumatology (Oxford))	临床2期	系统性红斑狼疮	306	Atacicept 150 mg	(廠繭窪鏇齋壓憲網鬱繭): OR = 3.82 (95% CI, 1.44 ~ 10.15), P-Value = 0.007 更多	-	2020-02-27
				Placebo
NCT00624338 \| NCT01972568 (ACR2019)	临床1/2期	系统性红斑狼疮 BLyS \| APRIL	540	Atacicept 25 mg	(糧築窪鏇蓋網齋願觸窪) = 鹹構淵窪壓網衊獵糧遞醖製遞餘齋憲顧衊齋壓 (積蓋顧壓獵廠繭觸獵膚 ) 更多	-	2019-11-12
				Atacicept 75 mg	(糧築窪鏇蓋網齋願觸窪) = 選淵積鹹選窪鏇窪夢鹹醖製遞餘齋憲顧衊齋壓 (積蓋顧壓獵廠繭觸獵膚 ) 更多