An Open-label Study for Sutimlimab in Participants With Cold Agglutinin Disease (CAD) Who Have Completed the CARDINAL Study (BIVV009-03/EFC16215, Part B) or CADENZA Study (BIVV009-04/EFC16216, Part B) in Japan

This was a multi-center, single treatment-group, open-label study to provide sutimlimab to the adult participants with cold agglutinin disease (CAD) who had completed the CARDINAL (NCT number: NCT03347396) or CADENZA (NCT number: NCT03347422) studies and benefitted from sutimlimab treatment in Japan.
• Study and treatment duration: the period between the participant's completion of the CARDINAL and CADENZA studies and sutimlimab or other appropriate CAD therapy becoming commercially available to participants in Japan.

开始日期2021-11-11

申办/合作机构

Sanofi

NCT05791708

/ RecruitingN/A

Cold Agglutinin Disease Real World Evidence Registry

This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 [NCT02502903,CAD patients], BIVV009-03/EFC16215 [NCT03347396], and BIVV009-04/EFC16216 [NCT03347422]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.

开始日期2019-12-12

申办/合作机构

Recordati Rare Diseases

NCT03347396

/ Completed临床3期

A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to >= 12 g/dL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who had a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with CAD.

开始日期2018-03-05

申办/合作机构

Bioverativ, Inc.

100 项与 Sutimlimab 相关的临床结果

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100 项与 Sutimlimab 相关的转化医学

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100 项与 Sutimlimab 相关的专利（医药）

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项与 Sutimlimab 相关的文献（医药）

2025-07-11·Science Advances

Enhanced immunocompatibility and hemocompatibility of nanomedicines across multiple species using complement pathway inhibitors

Article

作者: Nebbia, Morgan ; Busquet, Nicolas ; Monte, Andrew ; Zelek, Wioleta M. ; Holers, V. Michael ; Simberg, Dmitri ; Jacques, Sarah ; Moghimi, S. Moein ; Lasda, Erika ; Scheinman, Robert I. ; Hasselberth, Jay ; Li, Yue ; Saba, Laura ; Gaikwad, Hanmant ; Banda, Nirmal K. ; Tomlinson, Stephen A.

The activation of complement by nanomedicines triggers immune uptake and proinflammatory responses. Complement pathway inhibitors could offer strategies to address these challenges. Here, we assess the efficacy of inhibitors with various nanoparticles, including dextran superparamagnetic iron oxide nanoworms, polyethylene glycol (PEG) liposomal drugs, and mRNA lipid nanoparticles. In human sera, inhibitors of the alternative pathway iptacopan and danicopan exhibit variable efficacies, ranging from high nanomolar to incomplete inhibition. However, both iptacopan and danicopan display poor efficacy with PEGylated liposomal doxorubicin. Sutimlimab, an inhibitor of the classical pathway, demonstrates poor efficacy with PEGylated liposomal doxorubicin, even in sera with anti-PEG antibodies. Iptacopan displays donor-dependent inhibition of the uptake of nanoparticles in human blood. Bolus coadministration of iptacopan with nanoworms in mice, rats, and dogs inhibits C3 opsonization and uptake by granulocytes. Iptacopan also alleviates nanoparticle-induced lethargy in rats and severe hypotension in dogs. These data suggest that complement inhibitors can enhance the immunocompatibility and hemocompatibility of nanomedicines in a donor-dependent manner.

2025-06-29·Cureus Journal of Medical Science

A Case of Cold Agglutinin Disease With Transformation to High-Grade Lymphoma During Sutimlimab Treatment

Article

作者: Shimada, Keiji ; Kaneko, Naoya ; Yamaguchi, Shota ; Saito, Kenki

Cold agglutinin disease (CAD) is an autoimmune hemolytic anemia characterized by monoclonal immunoglobulin M-mediated cold agglutinins and monoclonal B-cell proliferation. Sutimlimab, a complement C1s inhibitor, alleviates hemolytic anemia in CAD by blocking the classical complement pathway. We report a case of a 67-year-old Japanese woman with CAD who experienced temporal improvement in anemia following sutimlimab treatment. ¹⁸F-fluorodeoxyglucose positron-emission tomography/computed tomography and bone marrow biopsy (BMB) revealed histological transformation into aggressive B-cell lymphoma. Subsequent chemotherapy with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisolone resulted in further improvement in anemia. This case highlights the importance of reassessing underlying conditions through BMB in cases where sutimlimab treatment is ineffective.

2024-12-01·INTERNATIONAL JOURNAL OF HEMATOLOGY

Adult-onset severe paroxysmal cold hemoglobinuria after COVID-19 successfully treated with sutimlimab

Article

作者: Sumi, Masahiko ; Okajima, Sayaka ; Hara, Ryosuke ; Nakamura, Yusuke ; Sato, Keijiro ; Kayama, Ryuhei ; Kobayashi, Hikaru ; Kazama, Shintaro ; Komaba, Wataru ; Ishikawa, Ryuto ; Sunohara, Shunya

Paroxysmal cold hemoglobinuria (PCH) is a form of cold autoimmune hemolytic anemia characterized by the presence of the Donath-Landsteiner antibody, which triggers complement-mediated intravascular hemolysis when the body temperature changes from cold to warm. PCH occurs primarily in children as a rare, self-limiting disease following viral infections. In contrast, adult-onset PCH is very rare and associated with a diverse range of underlying conditions, which complicates its management and treatment. We describe a case of adult-onset PCH following COVID-19, effectively managed with a single dose of sutimlimab, a selective classical complement pathway inhibitor. This intervention was performed during a life-threatening hemolytic crisis, at a time requiring swift decision-making when specific tests to differentiate from other hemolytic anemias were not readily available. This case illustrates the potential of using a single dose of sutimlimab to manage life-threatening hemolytic crises in PCH, highlighting the significance of inhibiting the classical complement pathway.

项与 Sutimlimab 相关的新闻（医药）

2025-09-30

·EndPoints

Star gets $125M Series D as it begins Phase 3 in bleeding disorders

Star Therapeutics patched together a $125 million Series D in what it thinks is pharma’s next big therapeutic category. The South San Francisco startup expects the funds to add a few years of runway and get its sole clinical-stage drug most of the way through a Phase 3 trial in von Willebrand disease while also expanding into other disorders, CEO Adam Rosenthal told Endpoints News . The experimental drug, called VGA039, is currently in a Phase 1/2 study testing multiple doses against placebo in patients with VWD. Rosenthal said Star will “probably show some of that data” at this year’s American Society of Hematology annual meeting in Orlando in December. The trial is fully enrolled. Star initiated an open-label Phase 3 , with patients expected to begin crossing over into that trial next year, Rosenthal said. It’s expected to have results from the 60-patient study in 2028, according to the US federal trials database. The inherited bleeding disorder can lead to bleeding in the joints, muscles, gastrointestinal tract, mouth and elsewhere. “One of the most overlooked aspects of the disease is heavy menstrual bleeding,” Rosenthal said. Patients’ periods “could last weeks or even months at a time with really, really heavy volume loss, which can also lead patients to be anemic and transfusion-dependent,” he said. He predicts that VWD could be “one of the next frontiers in benign heme.” “I&I has been the hot area for a while, but it’s quite competitive,” Rosenthal said. “So a lot of investors are targeting hematology as the next big therapeutic area and looking for assets there.” Takeda markets an enzyme replacement therapy known as Vonvendi for patients with VWD. Patients must receive IV infusions twice a week. That’s a large burden on patients, Rosenthal said. However, Star’s VGA039 could offer once-a-month dosing via an under-the-skin injection done by the patient at home, Rosenthal said. The monoclonal antibody targets Protein S with the goal of rebalancing blood clotting. He likened the category to the evolving hemophilia treatment market. Roche’s subcutaneous antibody, Hemlibra, is approved for hemophilia A. It’s the Swiss pharma’s second-largest product, with more than $5 billion in sales last year. “We think that the heme B space has just recently transitioned to subQ products in the last year. Now it’s time for VWD,” Rosenthal said. Pfizer’s hemophilia A and B treatment Hympavzi was greenlit last October . Some of Star’s team of 40-plus employees previously worked on multiple hemophilia programs, including Hemlibra, Rosenthal said. A few come from True North Therapeutics, which was bought by Bioverativ in 2017 and then, in turn, was acquired by Sanofi. The French pharma markets Enjaymo for a rare type of anemia called cold agglutinin disease, which was developed by True North. Sanofi is now reconnecting with Rosenthal and some former True Northers. The pharma’s corporate venture arm, which has a new $625 million commitment, is one of the main investors in the Series D round. Viking Global Investors, Janus Henderson Investors, Frazier Life Sciences, GordonMD Global Investments and others also took part. In the first half of 2026, Star will talk about expanding VGA039 into other indications, which will likely start with small Phase 2 trials, Rosenthal said. VGA039 used to be part of a Star business known as Vega Therapeutics , but it’s all part of one team now, Rosenthal said. The company also used to have a branch called Electra Therapeutics, but that biotech was spun out in 2023 when it independently raised $80 million , Rosenthal said. Electra is testing a monoclonal antibody for a rare condition known as secondary hemophagocytic lymphohistiocytosis.

临床3期并购上市批准

2025-09-08

·FierceBiotech

Dianthus\' gMG prospect blooms, with phase 2 win setting up pivotal plans

Dosing is central to Dianthus Therapeutics\' plans to differentiate its candidate in a competitive market. \n Dianthus Therapeutics is advancing its challenge for the increasingly competitive generalized myasthenia gravis (gMG) market, outlining plans to move into phase 3 on the back of hits in a midphase study.The phase 2 trial compared two doses of claseprubart, an antibody engineered to selectively target the classical pathway, to placebo in 65 adults with AChR-positive gMG. Patients received claseprubart every two weeks via subcutaneous injection. While the primary endpoint looked at safety and tolerability, the secondary endpoint data provided a glimpse of the efficacy of the drug candidate. At the low dose, Dianthus reported a 4.6-point improvement on MG-ADL, a scale that measures the impact of gMG on daily functions. The improvement rose to 5.4 points on the high dose. Adjusted for placebo, the improvements on the low and high doses were 1.8 points and 2.6 points, respectively.Dianthus shared the results alongside data on QMG, a physician\'s score of disease severity. QMG scores improved 4.4 points and 4.5 points, respectively, on the low and high doses. Scores improved by two points in the placebo arm. Dianthus also reported statistically significant improvements on other measures of gMG. The biotech shared cross-trial comparisons to show how claseprubart performed against AstraZeneca’s Soliris and Ultomiris and UCB’s Zilbrysq. Claseprubart outperformed the competition in the data shared by Dianthus, with the caveat that such cross-trial comparisons can be unreliable. The company found the drug candidate was generally well tolerated, giving it a data set to inform talks with the FDA and preparations for phase 3. Dianthus plans to test two regimens of the low dose in phase 3, with patients receiving the study drug every two or four weeks. Dianthus didn’t test four-week dosing in the phase 2 study, but the lack of statistical difference between the low and high doses, coupled with evidence such as half-life data, led it to speculate that a less-frequent regimen could work. The two-week dose is Dianthus’ target product profile, but CEO Marino Garcia sees an opportunity to go beyond the base case.“Why not go further? Why not push that differentiation? I don\'t see much of a downside to be honest,” Garcia said on a call with investors to discuss the data. Dosing is central to Dianthus’ plans to differentiate its candidate in a competitive market. The company said more than 80% of patients with AChR-positive gMG have yet to switch to a biologic, despite the availability of C5 inhibitors such as Ultomiris and FcRn drugs, including argenx’s Vyvgart. Dianthus has identified intravenous and high-volume subcutaneous dosing as a barrier to uptake of rival drugs.That thinking led Dianthus to develop an autoinjector. The overarching goal is to combine the efficacy of C5 inhibitors such as Ultomiris with the safety of C1 blockers such as Enjaymo and the convenience of Dupixent. Analysts at Evercore ISI said in a note to clients that: “Both doses clearly met all the bull case efficacy bars” the firm had discussed in preview ahead these data. They added that the biotech “convincingly” matched the C5s. It didn’t see a dose response, thus “opening the door to a longer Q4W dosing interval.”

$Dianthus\' gMG prospect blooms, with phase 2 win setting up pivotal plans$

临床结果临床2期临床3期

2025-05-15

·CPHI制药在线

金笔奖|从罕见病到常见病，补体药物开疆拓土

关注并星标CPHI制药在线在创新药市场中，补体药物是一个重要领域，也是研发壁垒较高的一个赛道。但鉴于其拥有巨大的应用前景，近年来补体药物的研发进入快车道，其适应症范围也在逐步拓展。近日，诺华的补体因子B（CFB）抑制剂伊普可泮（Iptacopan，Fabhalta）获NMPA批准，用于成人C3肾小球病（C3G）的治疗，这是补体药物在肾病治疗领域解锁的又一块拼图。该适应症的获批，彰显了补体药物的巨大潜力，同时也将其研发热度再次掀起。01伊普可泮的适应症版图伊普可泮是一款同类首创的CFB抑制剂，通过与补体旁路途径中的FB结合，调节C3的裂解、下游效应物的产生和末端途径的放大，控制C3b介导的血管外溶血和末端补体介导的血管内溶血。2023年12月，伊普可泮首次获FDA批准，治疗成人阵发性睡眠性血红蛋白尿症（PNH）。PNH是一种罕见的血液系统疾病，发病率约为每百万人口1～10例，已被纳入我国《第一批罕见病目录》。该病临床主要表现为血管内溶血、骨髓衰竭和高风险并发血栓等，虽为良性血管内溶血性疾病，但严重者可危及生命。在补体抑制剂获批前，PNH主要以支持治疗为主，包括红细胞输注、补充造血原料、糖皮质激素和雄激素的使用以及免疫抑制剂的应用。但是传统支持治疗疗效有限，多数患者无法摆脱输血依赖，且患者10年总生存率仅70.7%~77.6%，生存率及生活质量亟待提高。伊普可泮的上市，改变了PNH的治疗局面。在APPOINT-PNH研究中，在未接受过补体抑制剂治疗的成人PNH患者中，给予伊普可泮单药治疗后，92%的患者在未输注红细胞的情况下血红蛋白水平相较基线增加≥2g/dL，近2/3患者的血红蛋白恢复至正常水平（≥12g/dL），98%的患者避免输血。同时，患者的疲劳症状表现出具有临床意义的改善。而且伊普可泮避免患者不断往返于居住地和医院，提高了患者依从性，使PNH从一个几乎不可治愈、危及生命的严重疾病转变为可接受长期管理的慢性疾病。2024年8月，FDA再次批准伊普可泮新适应症，用于降低成人IgA肾病（IgAN）患者的蛋白尿水平，这些患者有疾病迅速进展的风险。IgAN是一种罕见的异质性、进行性肾脏疾病。全世界每年每百万人中约有25人被新诊断为IgAN，由于患者具有持续较高水平的蛋白尿，因此可能在10年内进展为肾衰竭。在III期APPLAUSE-IgAN研究中，与安慰剂组相比，伊普可泮组患者的蛋白尿水平减少了38.3%（p<0.0001），并减缓了肾功能下降速度。而且伊普可泮的安全性和耐受性良好，与既往研究一致。伊普可泮的这一突破性进展，为IgA肾病的精准治疗开辟了新途径。2025年3月，伊普可泮获FDA批准，用于治疗成人C3肾小球病（C3G），以减少蛋白尿。这是第一个获批上市的C3G疗法。C3G是一种极其罕见的进行性肾脏疾病，多见于儿童和年轻人。每年全球每百万人中约有1-2人确诊。大约一半的C3G患者在诊断后10年内进展为肾衰竭，需要终身透析和/或肾移植。在III期APPEAR-C3研究中，评估了伊普可泮（200mg，每日2次）在原发性C3G患者中的疗效和安全性。结果显示，伊普可泮可迅速降低蛋白尿，最早在第14天见效，并持续至第12个月。同时，伊普可泮在研究中也表现出了良好的耐受性和安全性。伊普可泮自上市以来，短短两年多时间，已顺利获批三项适应症，曾被行业媒体Evaluate列为10款值得关注的潜在重磅疗法之一。02打破治疗困局，补体药物围攻罕见病补体系统是人体先天免疫系统的一部分，由大约50种蛋白质及蛋白质片段组成，主要由肝脏细胞和巨噬细胞产生，具有增强抗体、吞噬细胞、清除生物体中的微生物和受损细胞、攻击入侵病原体等能力。正常情况下，补体处于无活性状态，只有被某些因子激活后才产生具有生物活性的裂解片段，作用于相应靶细胞的受体而发挥生物学效应。补体被活化后产生大量具有活性的裂解产物如：C1q、C3a、C3b、C5a、C5b-9等。这些裂解产物有介导细胞溶解、调节细胞吞噬、清除免疫复合物和损伤凋亡细胞等生物学效应。补体激活途径主要有三条：经典激活（Classical pathway），凝集素激活（Lectin pathway）和旁路激活（Alternative pathway）。经典激活是由抗原抗体复合物结合C1q启动；凝集素激活发生在感染早期，机体炎症反应诱导肝细胞释放急性期蛋白MBL，C反应蛋白等。旁路激活是指病原微生物直接从C3激活。由于补体网络极其复杂，他在激活与调控之间维持着精妙的平衡，因此补体的选择性抑制十分重要，相关药物研发因此困难重重。目前已获批上市的补体药物有10款，适应症多集中于PNH等罕见病。2007年，由Alexion（于2020年被阿斯利康收购）研发的Soliris（eculizumab）获批上市，是全球获批的首款C5补体抑制剂，也成为了当时PNH首个也是唯一的治疗药物。Soliris成为了全球最畅销的罕见病药物之一。目前，除PNH外，Soliris已批准多种罕见病，包括：非典型溶血尿毒症综合征（aHUS）、全身型重症肌无力（gMG）、视神经脊髓炎谱系障碍（NMOSD）。2018年，阿斯利康的第二代、长效C5补体抑制剂Ultomiris（ravulizumab）获FDA批准上市。与Soliris相比，Ultomiris每年需要的输液次数减少，并具有良好的疗效和安全性。目前该药已批准的适应症包括PNH和aHUS。Ultomiris的业绩依然不容小觑，2020年销售额就达到了10.77亿美元。在阿斯利康两款重磅药物影响下，投入补体药物研发的药企越来越多。从2021年开始，补体药物研发进入快车道。2021年5月，Apellis Pharmaceuticals的C3补体抑制剂Empaveli（pegcetacoplan）获FDA批准上市，用于治疗PNH成人患者，成为首个FDA批准的用于治疗PNH的C3靶向疗法。2021年9月，安进和CSL Vifor共同开发的阿伐可泮（avacopan）获FDA批准上市，用于联合包括糖皮质激素在内的标准治疗方案治疗成人活动性严重ANCA相关血管炎（MPA和GPA）。阿伐可泮是一种补体5a受体（C5aR）拮抗剂，可抑制C5aR和过敏毒素C5a之间的相互作用，阻断C5a介导的中性粒细胞激活和迁移。阿伐可泮是FDA批准的首款口服补体5a受体拮抗剂。2022年，赛诺菲的补体C1s单抗Enjaymo(Sutimlimab)获FDA批准上市，用于冷凝集素病（CAD)患者降低由于溶血导致的红细胞输注需求。Sutimlimab通过阻断经典补体途径中C1s蛋白的功能而发挥抑制溶血的作用，是FDA批准的首款用于治疗CAD的补体C1s抗体。此后几年，安斯泰来的Izervay（avacincaptad pegol）、再生元的Veopoz（Pozelimab）、UCB的Zilbrysq相继获批上市，其中Izervay是一款旨在抑制补体C5蛋白的聚乙二醇化RNA适配体；Veopoz则是一款新一代补体C5单抗；Zilbrysq是一款新型大环肽类C5补体抑制剂。总之，目前已上市的补体药物大多采用从罕见血液疾病切入的研发策略，逐步向常见病领域跃迁。03从罕见病到常见病，补体药物厚积薄发由于补体系统在免疫调节、炎症反应等过程中都起着重要作用，近年来，补体药物不断向常见病领域探索。2023年，Apellis Pharmaceuticals的pegcetacoplan获FDA批准，成为第一款治疗地图样萎缩（GA）的药物。GA是干性年龄相关性黄斑变性（AMD）的一种晚期形式。AMD是一种影响眼后部部分黄斑的疾病，一些AMD患者最终会发展为GA。GA可导致进行性和永久性视力丧失。而且如果患者一只眼睛患有GA，则很有可能在另一只眼睛中也患上该疾病，严重影响患者生活质量。据悉，美国近2000万成年人患有某种形式的年龄相关性AMD，其中有100万人患有GA。全球GA患者人数估计超过500万。Pegcetacoplan在GA上的突破，标志着补体药物在常见病领域的破冰。2025年2月，安斯泰来宣布FDA批准其Izervay用于治疗GA的补充新药申请（sNDA）。经此次批准，Izervay的给药持续时间再无限制——为医生和患者管理GA提供了更大的灵活性。这些成果验证了补体系统在视网膜疾病治疗中的作用，全方位展示补体药物的广泛治疗益处。在经过数十年的探索后，补体药物的开发终于迎来了快速爆发期，靶点从C5拓展到C3、C5a、C1s、CFB等，药物类型也从单克隆抗体拓展到环肽、小分子、核酸药物等，适应症更是从罕见病向常见病拓展。总的来说，补体药物的研发虽然困难，但非常值得持续探索。主要参考资料： 1.https://www.novartis.com/sites/novartis_com/files/q2-2024-investor-presentation.pdf.2.Risitano AM, Röth A, Soret J, et al. Addition of iptacopan, an oral factor B inhibitor, to eculizumab in patients with paroxysmal nocturnal haemoglobinuria and active haemolysis: an open-label, single-arm, phase 2, proof-of-concept trial. Lancet Haematol. 2021;8(5):e344-e354.3.Peffault de Latour R, Röth A, Kulasekararaj AG, et al. Oral Iptacopan Monotherapy in Paroxysmal Nocturnal Hemoglobinuria. N Engl J Med. 2024 Mar 14;390(11):994-1008. 作者简介:@小饼，药学硕士，现为疾控工作人员，每天游走于纷繁复杂的数据里，深感自己渺小的同时，又庆幸能够见证中国生物医药发展的黄金时代。希望和各位共同学习、提高。END【企业推荐】领取CPHI & PMEC China 2025展会门票来源：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~

临床结果临床3期申请上市

100 项与 Sutimlimab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11530	Sutimlimab	-	DB14996

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
溶血性贫血	欧盟	Recordati Rare Diseases	2022-11-15
溶血性贫血	冰岛	Recordati Rare Diseases	2022-11-15
溶血性贫血	列支敦士登	Recordati Rare Diseases	2022-11-15
溶血性贫血	挪威	Recordati Rare Diseases	2022-11-15
冷凝集素病	美国	Recordati Rare Diseases, Inc.	2022-02-04
溶血	美国	Recordati Rare Diseases, Inc.	2022-02-04

未上市

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
免疫性血小板减少症	临床1期	美国	Bioverativ, Inc.	2017-08-14
免疫性血小板减少症	临床1期	德国	Bioverativ, Inc.	2017-08-14
免疫性血小板减少症	临床1期	英国	Bioverativ, Inc.	2017-08-14
补体紊乱	临床1期	奥地利	Bioverativ, Inc.	2015-07-13
终末期肾脏病	临床1期	奥地利	Bioverativ, Inc.	2015-07-13
大疱性类天疱疮	临床1期	奥地利	Bioverativ, Inc.	2015-07-13

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临床结果

适应症

分期

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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


PF1202 (EHA2025)	临床3期	冷凝集素病	25	Sutimlimab 7.5g iv/14 days	鑰憲壓顧鹽顧衊蓋齋願(餘鹽夢醖衊憲鑰製夢餘) = At the last follow up only one patient had died due to progressive WM with sepsis 蓋艱築構構範鹽糧願選 (簾積鹽膚醖蓋壓淵鹽網 ) 更多	积极	2025-05-14
				Sutimlimab 6.5g
NCT03347396 \| NCT03347422 (CARDINAL \| CADENZA, EHA2024)	临床3期	冷凝集素病	-	SUTIMLIMAB (Mild Anemia (≥10 g/dL))	餘餘醖襯製艱鹹衊壓壓(構蓋壓壓淵積鹹鏇蓋選) = 襯醖壓遞構壓觸鑰鏇網繭範願膚鏇網築衊製鬱 (鬱襯淵淵顧鹹顧範獵觸, 1.55) 更多	积极	2024-05-14
				SUTIMLIMAB (Moderate Anemia (≥8 - <10 g/dL))	餘餘醖襯製艱鹹衊壓壓(構蓋壓壓淵積鹹鏇蓋選) = 鏇膚窪鏇廠顧觸積繭壓繭範願膚鏇網築衊製鬱 (鬱襯淵淵顧鹹顧範獵觸, 1.53) 更多
NCT03347396 (CARDINAL, Pubmed \| Blood Adv)	临床3期	冷凝集素病	22	Sutimlimab	夢壓蓋衊膚獵構艱積願(顧齋憲廠鬱餘窪夢窪鏇) = 製襯餘繭壓齋廠簾鏇築壓積鏇選窪鬱窪獵構膚 (積壓餘廠廠網簾製憲鹽, 5.6) 更多	积极	2023-10-10
NCT05132127 (CTgov)	临床3期	冷凝集素病	7	sutimlimab	鏇壓觸壓築壓糧鹹窪選 = 簾蓋築膚網網鬱鏇醖簾糧糧獵繭衊遞艱膚壓構 (積蓋鹽範壓窪選餘築艱, 積繭鹽網選糧繭鑰夢網 ~ 餘淵鹹淵積廠壓憲遞鑰) 更多	-	2023-10-03
CARDINAL and CADENZA (ISTH2023)	临床3期	冷凝集素病	66	PRE-sutimlimab	鑰夢鑰選構觸選觸鬱網(繭艱製構餘夢廠淵願餘) = 淵艱鹽鏇衊鹽廠蓋繭艱構鏇襯構鹹夢鏇壓襯遞 (積餘膚憲憲遞蓋鏇廠觸 )	-	2023-06-24
				ON-sutimlimab	鑰夢鑰選構觸選觸鬱網(繭艱製構餘夢廠淵願餘) = 積艱獵夢範觸餘壓遞鏇構鏇襯構鹹夢鏇壓襯遞 (積餘膚憲憲遞蓋鏇廠觸 )
NCT03347422 (CADENZA, EHA2023)	临床3期	冷凝集素病	39	Sutimlimab	網鹹襯鹽蓋顧選顧壓衊(製網觸遞願艱衊網醖餘) = Thromboembolic events were observed in 2 (5.1%) pts (transient ischemic attack [n=1]; deep vein thrombosis [n=1]); both events occurred in pts with underlying risk factors for thromboembolism and were assessed as non-serious and unrelated to SUT by the Investigator. 觸糧鹽築鬱鹽襯築憲艱 (夢窪齋獵餘鏇鏇製獵壓 ) 更多	-	2023-06-08
				Placebo
NCT03347422 (CADENZA, EHA2023)	临床3期	冷凝集素病	42	Sutimlimab	鏇壓鑰範構範鹽繭繭選(廠範範簾鏇壓餘網構網) = Raynaud¡¯s phenomenon (1 [2.6%] pts) 積製廠顧憲製蓋夢壓糧 (艱窪範鑰遞夢獵遞鏇蓋 ) 更多	-	2023-06-08
				Placebo
NCT03347396 (CARDINAL, Pubmed)	临床3期	冷凝集素病	22	Sutimlimab	築選網醖積齋遞襯廠願(醖鹹鹽淵繭範鏇獵窪簾) = After cessation of sutimlimab, most patients reported adverse events consistent with recurrence of CAD. 選襯簾艱觸繭積獵積選 (壓醖醖遞網齋願蓋顧顧 ) 更多	-	2023-05-29
NCT03347422 (CADENZA, CTgov)	临床3期	冷凝集素病	42	sutimlimab (BIVV009) (BIVV009/BIVV009)	願艱願淵觸範繭壓餘窪(壓築築憲鹹衊蓋廠蓋膚) = 顧製選繭觸構積淵夢顧鑰鏇壓繭鬱選艱廠觸獵 (鑰夢繭夢顧壓鏇夢夢鑰, 1.348) 更多	-	2022-12-23
				placebo+sutimlimab (BIVV009) (Placebo/BIVV009)	願艱願淵觸範繭壓餘窪(壓築築憲鹹衊蓋廠蓋膚) = 鹽衊鏇鑰憲鹽鹹壓窪積鑰鏇壓繭鬱選艱廠觸獵 (鑰夢繭夢顧壓鏇夢夢鑰, 1.545) 更多
NCT03347396 (CARDINAL, CTgov)	临床3期	冷凝集素病	24	BIVV009	齋觸繭膚壓鑰繭範網繭 = 獵壓鏇製範淵願憲壓鑰糧願鹹鏇糧製鏇鹹襯壓 (鹽顧衊廠鬱糧餘築窪獵, 願顧衊遞積憲製壓憲構 ~ 積簾窪觸鏇範憲願窪積) 更多	-	2022-10-31