An Open-Label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants With Primary Membranous Nephropathy (PMN) [PROMINENT]

In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys.
Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure.
In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease.
The main question that researchers want to answer is:
* How many participants achieve a complete response after 104 weeks of treatment?
* A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable.
Researchers will also learn about:
* How long it takes before the participants' disease gets worse
* How long the participants' urine protein levels stay low
* How many participants develop antibodies against felzartamab in the blood?
* How many participants achieve a complete response after 76 weeks of treatment
* How many participants have medical problems during the study
* How felzartamab is processed by the body
* How felzartamab affects participants' tiredness and overall physical health
The study will be done as follows:
* Participants will be screened to check if they can join the study. This may take up to 42 days.
* Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets.
* If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment.
* If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104.
* In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.

开始日期2025-05-22

申办/合作机构

Biogen, Inc.

NCT06935357

/ Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)

In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys.
The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is:
? How much does the amount of protein in the urine change from the start of the study to Week 36?
Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body.
The study will be done as follows:
* Participants will be screened to check if they can join the study.
* Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
* Neither the researchers nor the participants will know what the participants will receive.
* Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks.
* Afterwards, participants will enter a follow-up period which will last 80 weeks.
* In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.

开始日期2025-05-08

申办/合作机构

Biogen, Inc.

[+1]

NCT06685757

/ Recruiting临床3期

A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)

The main goal of this trial is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with late active or chronic active AMR.

开始日期2024-12-03

申办/合作机构

Biogen, Inc.

100 项与菲泽妥单抗相关的临床结果

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100 项与菲泽妥单抗相关的转化医学

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100 项与菲泽妥单抗相关的专利（医药）

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项与菲泽妥单抗相关的文献（医药）

2025-07-01·AMERICAN JOURNAL OF TRANSPLANTATION

Microvascular inflammation in kidney allografts: New directions for patient management

Review

作者: Loupy, Alexandre ; Sablik, Marta ; Böhmig, Georg A ; Naesens, Maarten

Microvascular inflammation (MVI) is a key histological feature of immune-mediated injury at the capillary interface of renal allografts, characterized by immune cell infiltration into glomerular and peritubular capillaries. Although traditionally associated with antibody-mediated rejection (AMR), many MVI cases lack detectable donor-specific antibodies (DSA), suggesting the involvement of antibody-independent immune mechanisms or alternative triggers, such as viral infections or ischemia-reperfusion injury. The Banff 2022 scheme introduced a subcategory, "MVI, DSA-negative, C4d-negative," within an overarching AMR or MVI category. This subcategory-similar to AMR-was shown to carry a significant risk of graft failure. Its recognition marks a major advancement, offering a robust framework for investigating the pathophysiology of MVI, which may involve a wide array of overlapping triggers. Emerging evidence from transcriptome analyses highlights natural killer cells as possible effectors, regardless of DSA status. Therapies targeting natural killer cells, particularly the anti-CD38 antibody felzartamab, have shown promising reductions in MVI and molecular injury. Notably, the US Food and Drug Administration has approved an MVI-based primary endpoint for a phase 3 trial evaluating this approach, representing a critical step toward the development of new therapeutics. Recognizing MVI as a multifaceted histological phenotype-driven by diverse triggers-may signal a paradigm shift in transplant medicine.

2025-06-01·KIDNEY INTERNATIONAL

Randomized, double-blind, placebo-controlled phase 2a study assessing the efficacy and safety of felzartamab for IgA nephropathy

Article

作者: Lafayette, Richard ; Faulhaber, Nicola ; Manser, Paul T ; Kräft, Tabea ; Barbour, Sean J ; Shah, Millie ; Floege, Jürgen ; Thakur, Anjali ; Kivman, Lisa ; Barratt, Jonathan ; Härtle, Stefan ; Schwartz, Brian ; Patel, Uptal D

INTRODUCTION:

Felzartamab is a fully human anti-CD38 monoclonal antibody under investigation for treatment of IgA nephropathy (IgAN). IGNAZ (NCT05065970) is a randomized, double blind, placebo-controlled Phase 2a study that assessed the efficacy and safety of felzartamab in 54 patients with biopsy-confirmed IgAN despite maximal renin angiotensin system blockade.

METHODS:

In Part 1, patients were randomized in the 6-month treatment period to receive intravenous placebo (12 patients) or felzartamab in three arms: two doses in 15 days (2-dose, 12 patients), five doses in 2 months (5-dose, 11 patients), or nine doses in five months (9-dose, 13 patients). In Part 2, six Japanese patients received the felzartamab 9-dose schedule open-label. Follow-up in Parts 1 and 2 was 24 and 12 months, respectively, after the first dose. The primary endpoint was change in proteinuria (urine protein to creatinine ratio [UPCR]) at nine months.

RESULTS:

Treatment with felzartamab versus placebo led to rapid (within 3-6 months) reduction in least-squares mean UPCR sustained at nine months (placebo, -5.7%; 2-dose, -12.5%; 5-dose, -12.8%; 9-dose, -29.5%; Part 2, -44.8%) and at 18 months after ending treatment (24 months), particularly in the 9-dose arm (-44.5%). Mean decreases in estimated glomerular filtration rate were lower with felzartamab than with placebo through 24 months in Part 1 and 12 months in Part 2. Felzartamab safety was consistent with prior observations; adverse events were predominantly grade 1 or 2.

CONCLUSIONS:

Our study shows treatment with felzartamab results in sustained reduction of proteinuria, suggesting disease improvement. Further evidence is needed to understand the impact of felzartamab on preservation of kidney function in high-risk patients with IgAN.

2025-05-01·NATURE MEDICINE

Effect of felzartamab on the molecular phenotype of antibody-mediated rejection in kidney transplant biopsies

Article

作者: Jilma, Bernd ; Mackova, Martina ; Gauthier, Patrick T ; Hinze, Christian ; Schütz, Ekkehard ; Mayer, Katharina A ; Diebold, Matthias ; Budde, Klemens ; Halloran, Philip F ; Chang, Jessica ; Schrezenmeier, Eva ; Böhmig, Georg A ; Patel, Uptal D

Abstract:

A recent randomized controlled trial demonstrated that treatment with anti-CD38 monoclonal antibody felzartamab suppressed antibody-mediated rejection (ABMR) in kidney transplant patients but with recurrence after treatment in some patients. Here we examined the molecular effects of 6 months of felzartamab treatment on biopsies from the trial using genome-wide microarray analysis, comparing pretreatment, end-of-treatment (week 24) and posttreatment (week 52) biopsies from ten patients treated with felzartamab and ten patients in the placebo group. Felzartamab reduced molecular ABMR activity scores in all nine patients with baseline ABMR activity, selectively suppressing interferon gamma-inducible and natural killer cell transcripts, with minimal effect on ABMR stage-related endothelial transcripts. Suppression was often incomplete when ABMR activity was intense, and molecular recurrence was nearly universal by week 52. However, we also found that felzartamab had parenchymal benefits at week 52, slowing the trajectories of molecular injury scores beyond the treatment period, suggesting that suppression of ABMR activity could potentially slow future progression to kidney failure. These data provide preliminary molecular insights into the effects of CD38-directed treatment for ABMR, which have the potential to inform future therapeutic strategies.

179

项与菲泽妥单抗相关的新闻（医药）

2025-07-21

·CPHI制药在线

IgA肾病新药大爆发，Sibeprenlimab获优先审评，多款进入3期临床

关注并星标CPHI制药在线IgA肾病是沉默的"肾脏杀手"，是全球范围内最常见的原发性肾小球疾病之一。IgA肾病"偏爱"青壮年，临床表现多样，包括水肿、疲劳、肉眼血尿等，严重影响患者的生活质量。若不及时干预，绝大多数IgA肾病患者在10~15年内进展为终末期肾病（ESRD），最终需要透析或肾移植。IgA肾病的发病和发展机制复杂，目前普遍认为与免疫系统紊乱相关，比较公认的是"四重打击"学说。第一重打击：在遗传易感性基础上，个体遭遇潜在的细菌或者病毒感染后激发黏膜免疫反应，身体免疫应答失调，产生致病性半乳糖缺陷的IgA1（Gd-IgA1），Gd-IgA1不能被唾液酸糖蛋白受体识别，从而肝细胞无法将其清除，导致Gd-IgA1在体内异常蓄积；第二重打击：针对致病性IgA1抗原，产生抗Gd-IgA1分子抗体（主要为IgG）；第三重打击：这些致病性IgA1抗原与抗体形成免疫复合物；第四重打击：抗原抗体免疫复合物沉积在肾脏系膜区，激活补体系统和其他介质，刺激系膜细胞增殖、分泌系膜基质、细胞因子等而致肾小球炎症反应，最终导致肾小球硬化和间质纤维化。传统IgA肾病治疗以支持治疗为主，如生活方式干预、肾素血管紧张素系统抑制剂（RASi）、钠葡萄糖协同转运蛋白 2 抑制剂（SGLT2i），以及糖皮质激素等免疫抑制剂治疗等。然而传统治疗手段疗效有限，残留肾衰风险较高。IgA肾病迎来多款新药近年来，随着对IgA肾病发病机制研究的深入，多款IgA肾病新药获批上市，其治疗策略也逐渐向多靶点的综合治疗策略转变，从传统糖皮质激素治疗时代走向基于发病机制的靶向治疗时代。据不完全统计，近年来全球监管机构批准了四款IgA肾病新药，即Nefecon（布地奈德肠溶胶囊）、Sparsentan（司帕生坦）、iptacopan（伊普可泮）和atrasentan（阿曲生坦），这四款药物均通过口服给药。其中Nefecon是一种布地奈德的缓释制剂，2021年12月被FDA加速批准用于降低有疾病快速进展风险(通常为尿蛋白与肌酐之比(UPCR) ≥1.5g/g)的成人原发性IgA肾病患者的蛋白尿。Sparsentan是一款双重内皮素血管紧张素受体拮抗剂，2023年2月被FDA批准用于具有疾病快速进展风险，且尿蛋白与肌酐比值（UPCR）≥1.5 g·g－1的原发性IgAN成人患者。iptacopan是一种口服的、补体旁路途径的B因子抑制剂，2024年8月被FDA批准用于降低成人IgA肾病患者的蛋白尿水平，这些患者有疾病迅速进展的风险。atrasentan是一款强效选择性ETA（内皮素A）受体拮抗剂，2025年4月被FDA加速批准用于降低有疾病进展风险的原发性IgA肾病成人患者的蛋白尿。遗憾的是，上述药物中仅Nefecon在国内获批治疗IgA肾病。据悉Nefecon自2024年5月在国内上市以来，7个月为云顶新耀贡献了3.53亿元收入，为公司贡献了一半的销售额。多款在研药物蓄势待发据不完全统计，全球还有多款在研IgA肾病新疗法进入临床后期，如Visterra/大冢制药的Sibeprenlimab（上市申请）、诺华/Chinook Therapeutics的Zigakibart（3期临床）、荣昌生物的泰它西普（3期临床）、Vertex /Alpine的povetacicept（3期临床）、渤健的Felzartamab（3期临床）、Vera Therapeutics的atacicept（3期临床）。其中Sibeprenlimab（VIS649）是大冢制药收购Visterra获得的一款抗增殖诱导配体（APRIL）单抗，通过结合和中和APRIL，减少IgA和致病性Gd-IgA1的数量。已公布的临床试验结果显示sibeprenlimab可减少IgA肾病蛋白尿，延缓eGFR下降。2025年5月，该药治疗IgAN的BLA获FDA受理，并被授予优先审评资格，PDUFA日期为2025年11月28日。Sibeprenlimab给药便捷，每4周皮下注射一次。值得一提的是，Sibeprenlimab已在国内申请上市，并被纳入优先审评。Zigakibart是诺华收购Chinook Therapeutics获得的一款抗APRIL人源化单抗。已公布的1/2期临床试验结果显示：Zigakibart可实现3个月内有临床意义的蛋白尿减少，并在研究期间持续降低血清Gd-IgA1，且在IgAN患者中耐受性良好。给药频率上，Zigakibart每2周皮下注射一次。泰它西普是一种新型重组融合蛋白，由跨膜激活剂、钙调节剂和亲环蛋白配体相互作用物（TACI）受体的配体结合结构域和人免疫球蛋白（IgG）的Fc段组成，通过靶向BLyS/APRIL双通路，抑制异常活化的B细胞和自身抗体生成，从源头干预IgAN的免疫病理过程。既往2期临床研究显示：泰它西普治疗24周（尤其是每周240mg的剂量）可有效降低IgAN患者蛋白尿。进一步分析表明，泰它西普还可降低IgAN患者的循环Gd-IgA1和IgA免疫复合物。Povetacicept是一种 Fc 融合蛋白，通过定向进化技术优化了TACI（跨膜激活剂和钙调磷酸酶配体相互作用分子）结构域，能够更有效地实现对BAFF和APRIL的双重抑制。该药每4周皮下注射一次，已公布的1b/2a期研究研究RUBY-3 的初步结果显示：Povetacicept在IgA肾病患者中显示出良好的耐受性和疾病活动度的改善，包括UPCR的降低和肾功能的稳定，同时伴随Gd-IgA1的减少。Felzartamab是一种抗CD38单克隆抗体，临床研究证实其能选择性地清除CD38阳性细胞，包括浆细胞，而浆细胞正是产生自身抗体（这些抗体错误地攻击身体自身组织）的源头。已公布的2a期临床试验结果显示：Felzartamab靶向抑制CD38的治疗可以持续减少IgA肾病患者的蛋白尿，改善IgAN的疾病预后。Atacicept是一种人源化的TACI-Fc融合蛋白，能够抑制BAFF和APRIL，从而减少B细胞的激活和自身抗体的产生。Atacicept治疗IgAN的2期临床数据显示：第36周时，与安慰剂相比，全Atacicept组都观察到蛋白尿的进一步减少；eGFR变化稳定；GD-IgA1持续降低。安全性、耐受性良好。2025年5月，atacicept治疗IgA肾病的 3期临床试验ORIGIN达到主要终点，受试者蛋白尿水平显著降低。此外，恒瑞医药的HR19042、Biohaven的BHV-1400等也被开发用于治疗IgA肾病，其中HR19042胶囊是由恒瑞医药自主研发并具有知识产权的改良型新药，为口服肠溶缓释胶囊。BHV-1400是Biohaven基于其胞外蛋白分子降解剂（MoDE）技术平台开发的一款靶向去除异常蛋白（TRAP）降解剂，据悉其可以实现在精准降低IgA肾病的致病性抗体水平且同时维持正常的正常免疫球蛋白水平。已公布的1期临床试验结果显示：BHV-1400可以在单次给药4h内迅速、强效、选择性降低IgA肾病患者的致病性Gd-IgA1抗体水平，同时将IgA等免疫球蛋白的水平保持在正常范围内。总结据弗若斯特沙利文数据，全球IgA肾病治疗药物市场保持快速增长，预计从2020年的5.67亿美元增至2025年的11.96亿美元。随着越来越多IgA肾病新药的获批上市，该领域势必将展开激烈进展，市场规模不断膨胀。END来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

优先审批临床3期上市批准加速审批临床结果

2025-07-09

·PMLiVE

Biogen initiates phase 3 study of felzartamab in kidney disease patients

Biogen has announced that it has initiated a phase 3 study of investigational felzartamab in adults with primary membranous nephropathy (PMN), a severe antibody-mediated kidney disease. The 104-week PROMINENT trial, expected to readout in 2029, will randomise approximately 180 patients with moderate- to -high-risk PMN to receive either felzartamab or tacrolimus. It will enrol both newly diagnosed and relapsed patients, and will compare the efficacy and safety of the two drugs in achieving complete remission of protein in the urine (proteinuria). Approximately 36,000 people in the US are affected by PMN, which carries a significant risk of kidney failure and currently has no specifically approved treatments. The condition is a leading cause of nephrotic syndrome, which often presents with very severe swelling and fatigue related to high-grade proteinuria. Despite treatments ranging from immunosuppressants to chemotherapy, approximately one third of patients do not achieve remission. Felzartamab has already been shown in clinical studies to selectively deplete CD38-positive plasma cells, which Biogen said “may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies”. Travis Murdoch, head of the Biogen West Coast Hub, said the company is “encouraged by the opportunity to advance a phase 3 study for PMN, a condition that carries a significant risk of kidney failure”. Biogen gained access to felzartamab in July through its $1.8bn acquisition of Human Immunology Biosciences (HI-Bio), which had exclusively licensed the rights to develop and commercialise the asset across all indications in all countries and territories excluding China in 2022. The drug was originally developed by MorphoSys, which Novartis also acquired last year. Beyond PMN, Biogen has recently initiated two phase 3 studies of felzartamab in IgA nephropathy, and kidney transplant recipients who have been diagnosed with late antibody-mediated rejection. Principal investigator for the PROMINENT trial, Mohamed El-Shahawy, said: “Felzartamab’s mechanism of action designed to deplete the cells that produce the pathogenic antibodies is exciting news for patients that are waiting for potential meaningful new treatment options. “I’m grateful that Biogen is advancing research in this rare kidney disease and am eager to see the continued progress in the study’s enrolment.”

临床3期并购免疫疗法

2025-07-01

·医药速览

渤健启动CD38单抗的III期临床试验，治疗原发性膜性肾病

6月30日，渤健Biogen宣布，其全球性三期临床研究PROMINENT已正式启动患者给药，旨在评估创新药物Felzartamab对成人原发性膜性肾病PMN患者的疗效与安全性。这项里程碑式的研究，对比的是当前标准疗法中的他克莫司（tacrolimus），预示着在这一尚无特异性获批疗法的罕见免疫介导性疾病领域，未来或将迎来重大突破。原发性膜性肾病是一种严重的抗体介导性肾脏疾病，是肾病综合征的主要原因之一，并伴随着显著的肾功能衰竭风险。患者常常因严重的蛋白尿而出现全身水肿和疲劳，感染风险也随之增加。尽管目前有从免疫抑制剂到化疗等多种治疗方案作为标准护理，但仍有约三分之一的患者无法实现缓解。Felzartamab是一种研究性抗CD38单克隆抗体，被认为是极具潜力的差异化治疗候选药物，有望应用于广泛的免疫介导性疾病。临床研究已证实，Felzartamab能选择性地清除CD38阳性细胞，包括浆细胞，而浆细胞正是产生自身抗体（这些抗体错误地攻击身体自身组织）的源头。对于PMN患者而言，这一点尤为重要，因为据估计，高达80%的PMN患者体内存在由表达CD38的浆细胞产生的抗PLA2R（aPLA2R）自身抗体。通过靶向并清除这些致病性抗体产生的源头，Felzartamab有望从根本上解决PMN的病理机制。这项名为PROMINENT的三期临床试验（NCT06962800）是一项为期104周、随机、开放标签、全球多中心研究。它计划招募约180名中高风险的PMN成人患者，包括新诊断和复发患者。试验的主要终点是评估患者在第104周达到蛋白尿完全缓解的百分比。这项研究将同时评估抗PLA2R自身抗体阳性及阴性患者，并根据PLA2R水平进行分层。血清抗磷脂酶A2受体（PLA2R）抗体水平的变化以及患者报告的结局将作为关键的次要终点进行评估。这是渤健今年启动的第三项Felzartamab三期临床试验，除了PMN，渤健今年还启动了Felzartamab针对肾移植受者晚期抗体介导性排斥反应（TRANSCEND研究，NCT06685757）和IgA肾病（PREVAIL研究，NCT06935357）的两项三期研究。在此之前，Felzartamab已在两项二期研究（M-PLACE和NewPLACE）中进行了评估，这些研究均招募了aPLA2R阳性PMN患者。M-PLACE研究的最终分析显示，大多数患者的aPLA2R滴度在短短一周内就观察到下降（中位下降45%），并且在治疗结束的六个月时，大多数患者的反应率（下降幅度超过50%）显著。此外，Felzartamab的使用还观察到蛋白尿和血清白蛋白水平的改善。在这两项研究中，大多数治疗期不良事件（TEAEs）为轻度至中度，并与Felzartamab在PMN人群中的已知作用机制一致。此次启动Felzartamab治疗PMN的三期研究，再次彰显了CD38单抗在罕见肾脏病领域潜力。推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。有问题可发邮件至yong_wang@pku.edu.cn获取更多信息。©2021 医药速览保留所有权利往期链接“小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记PROTAC技术| 抗体药物| 抗体药物偶联-ADC核酸疫苗 | CAR技术| 化学生物学温馨提示医药速览公众号目前已经有近12个交流群（好学，有趣且奔波于医药圈人才聚集于此）。进群加作者微信（yiyaoxueshu666）或者扫描公众号二维码添加作者，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。简单操作即可星标⭐️医药速览，第一时间收到我们的推送①点击标题下方“医药速览” ②至右上角“...” ③点击“设为星标

临床3期临床2期临床失败寡核苷酸

100 项与菲泽妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16375

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
多发性骨髓瘤	申请上市	中国	天境生物科技（杭州）有限公司	2025-01-08
特发性膜性肾病	临床3期	美国	Biogen, Inc.	2025-05-22
免疫球蛋白a肾病	临床3期	美国	Biogen, Inc.	2025-05-08
免疫球蛋白a肾病	临床3期	日本	Biogen, Inc.	2025-05-08
抗体介导的排斥反应	临床3期	美国	Biogen, Inc.	2024-12-03
抗体介导的排斥反应	临床3期	澳大利亚	Biogen, Inc.	2024-12-03
抗体介导的排斥反应	临床3期	奥地利	Biogen, Inc.	2024-12-03
抗体介导的排斥反应	临床3期	加拿大	Biogen, Inc.	2024-12-03
抗体介导的排斥反应	临床3期	德国	Biogen, Inc.	2024-12-03
抗体介导的排斥反应	临床3期	西班牙	Biogen, Inc.	2024-12-03

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临床结果

适应症

分期

评价

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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


NCT05065970 (IGNAZ, ASN2024) 人工标引	临床2期	免疫球蛋白a肾病	54	Felzartamab (2 doses in 15 days)	鏇簾獵齋築壓淵廠顧鬱(憲窪膚糧齋網積顧醖繭) = Treatment with felzartamab led to rapid, clinically meaningful reductions in UPCR vs PBO, with the greatest effect in the M3 arm. 顧構餘鏇醖齋網艱襯範 (繭顧糧鏇願觸襯網糧構 ) 更多	积极	2024-10-26
				Felzartamab (5 doses in 2 months)
NCT04145440 (M-PLACE, Pubmed) 人工标引	临床1/2期	特发性膜性肾病 anti-Phospholipase A2 receptor autoantibody-positive	31	Felzartamab 16 mg/kg	鑰餘鏇艱鑰繭餘衊鹹願(淵憲蓋糧憲製繭願醖網) = 鏇選製範構繭遞蓋築艱餘簾積餘餘襯積廠鹹範 (膚選鹹膚鹽衊網艱鏇範 ) 更多	积极	2024-06-20
				Felzartamab 16 mg/kg (newly diagnosed or relapsed PMN)	鹹網築選顧憲鏇鑰餘鹹(淵夢範網憲鬱獵憲網廠) = 壓膚獵鹹廠膚醖製淵選獵齋衊製醖壓積蓋簾醖 (簾顧襯顧壓鏇憲選網鹽 )
NCT05021484 (NEWS) 人工标引	临床2期	肾移植排斥反应	22	Felzartamab	獵築艱築獵壓遞餘製衊(鑰願衊製艱壓醖膚齋選) = felzartamab showing an acceptable safety profile and most adverse events being mild or moderate. 醖顧襯蓋糧鏇淵艱餘鑰 (鏇鑰夢鬱網遞廠窪衊壓 )	积极	2024-05-27
				Placebo
NCT05065970 (IGNAZ, PRNewswire) 人工标引	临床2期	免疫球蛋白a肾病	54	Felzartamab	鏇鑰蓋獵築鑰獵廠鬱鹹(襯襯繭襯選觸蓋範艱獵) = 鑰構醖鹹簾夢淵鬱糧壓鏇鏇遞鏇遞襯鑰願遞鏇 (繭繭淵遞範遞鏇網遞顧 )	积极	2024-05-24
				Placebo	-
NCT04145440 (M-PLACE, ASN2023) 人工标引	临床1/2期	特发性膜性肾病一线	31	Felzartamab	構築憲繭網簾憲製選積(餘鹽觸蓋網遞鹽選憲網) = 鹽選顧窪觸鏇選餘醖廠窪衊遞壓夢觸網鹹範願 (觸獵選淵顧顧遞淵觸襯 ) 更多	积极	2023-11-02
				Felzartamab (newly diagnosed or relapsed patients)	鬱窪獵衊衊遞夢淵獵窪(鏇積夢構製積願醖構鏇) = 範廠齋繭衊艱夢選繭選襯壓願簾遞網鏇獵廠簾 (鑰糧觸製鏇餘願遞襯壓 ) 更多
NCT04145440 (M-PLACE, ASN2022)	临床1/2期	膜性肾小球肾炎 anti-PLA2R Abs	31	Felzartamab (MOR202) 16 mg/kg	製衊蓋構網網艱膚齋壓(顧範鬱鑰夢艱遞齋觸鹹) = 製願憲齋鏇築憲膚鏇遞繭膚夢遞製窪襯築餘遞 (鑰夢網觸築鹽鏇鏇鏇積 )	积极	2022-11-05
NCT01421186 (ASCO 12017 \| ASCO 22017) 人工标引	临床1/2期	多发性骨髓瘤	44	dexamethasone+MOR202	製艱獵鬱構遞積餘網鬱(製鑰願繭襯窪選範遞憲) = The MTD of MOR202 was not reached 鹹衊製憲簾餘餘夢窪遞 (鏇憲憲蓋淵願鬱鑰積艱 )	积极	2017-06-05
				dexamethasone+lenalidomide+MOR202