A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

The purpose of this Phase 3 study is to demonstrate the efficacy of DNTH103 as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).

开始日期2025-02-10

申办/合作机构

Dianthus Therapeutics, Inc.

NCT06537999

/ Recruiting临床2期

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Multifocal Motor Neuropathy (MOMENTUM)

The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with multifocal motor neuropathy (MMN).

开始日期2024-09-17

申办/合作机构

Dianthus Therapeutics, Inc.

NCT06282159

/ Active, not recruiting临床2期

A Phase 2, Randomized, Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)

The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG).

开始日期2024-02-23

申办/合作机构

Dianthus Therapeutics, Inc.

100 项与 Claseprubart 相关的临床结果

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100 项与 Claseprubart 相关的转化医学

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100 项与 Claseprubart 相关的专利（医药）

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项与 Claseprubart 相关的文献（医药）

2022-11-01·ACS omega

Characteristics of Mechanical Properties and Thermal Behavior of Epoxy Nanocomposites and Coatings by Zinc Borate, Nano Silica, and Hardener

Article

作者: Huy, Cuong Huynh Le ; Thanh, An Truong

This study reports the ability of zinc borate (ZB) and nano silica (NS) in improving mechanical properties and thermal behavior of nanocomposites and coatings composed of epoxy resin EPIKOTE 1001 × 75 cured with hardener T31. The properties of the fabricated nanocomposites were characterized using scanning electron microscopy, transmission electron microscopy, thermogravimetric analysis, derivative thermogravimetry, differential scanning calorimetry, and dynamic mechanical analysis. With the addition content of 5 wt % ZB into epoxy resin (EPIKOTE 1001 × 75/T31/ZB-5), the impact strength of the fabricated epoxy polymer film increased by 50%, and the glass transition temperature (T _g) increased from 52 to 71 °C. By adding the content of 5 wt % ZB and 1 wt % NS into epoxy resin (EPIKOTE 1001 × 75/T31/ZB-5/NS-1), the impact strength of the formed epoxy nanocomposite films increased by 137.5%, and T _g increased from 52 to 82 °C. The results showed that 5 wt % ZB, 1 wt % NS, and hardener T31 improved the toughness and mechanical properties of epoxy polymer materials. The thermal stability of epoxy composite EPIKOTE 1001 × 75/T31/ZB-5 increased by 1.9% and that of epoxy nanocomposite EPIKOTE 1001 × 75/T31/ZB-5/NS-1 increased by 4.7%. The epoxy coating based on epoxy resin EPIKOTE 1001 × 75/T31/ZB-5/NS-1 achieved mechanical properties and had the strongest decomposition temperature at 642 °C.

2020-04-01·Journal of chromatography. A2区 · 化学

Potential of topological descriptors to model the retention of polychlorinated biphenyls in different gas chromatography stationary phases, including ionic liquid-based columns

2区 · 化学

Article

作者: Ros, M ; Sanz, M L ; Sanz, J ; Ramos, L ; Escobar-Arnanz, J

The aim of this study was to develop a statistical model based on a set of intuitive topological descriptors that will help to determine the influence of the polychlorinated biphenyls (PCBs) structural features on the chromatographic behavior of these analytes in a variety of gas chromatographic stationary phases, including the highly polar ionic liquid (IL)-based SLB-IL76 and SLB-IL60 columns. The model was developed using the stepwise multiple linear regression method, and constructed through several levels of increasing complexity to make evident the relative influence of the selected descriptors. The proposed model was easy to implement and provided similar satisfactory results irrespective of the dependent variables used (i.e., retention index or retention time) or the chromatographic conditions applied (i.e., pseudo-isotherm and programmed temperature) for IL-based phases. The model also allowed the correct prediction of the elution order of selected PCBs in these and other less polar phases evaluated (i.e., SW-10, DB-17, ZB-5 and HT-8). To our knowledge, this is the first models based on topological descriptors described in the literature that provided a satisfactory fitting of the PCB behavior in IL-based phases. Our results indicated that the mechanism governing the chromatographic separation of PCBs in these highly polar columns showed significant differences compared with those observed in other less polar stationary phases.

2008-04-01·Journal of chromatography. A2区 · 化学

Comprehensive two-dimensional gas chromatography in the screening of persistent organohalogenated pollutants in environmental samples

2区 · 化学

Article

作者: Bordajandi, L. R. ; Gonzalez, M. J. ; Sanz, J. ; Ramos, L. ; Ramos, J. J.

Separations of eight persistent organohalogenated classes of pollutants, organochlorinated pesticides (OCPs), polychlorinated biphenyls (PCBs), polychlorinated diphenyl ethers (PBDEs), polychlorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs), polychlorinated naphthalenes (PCNs), polychlorinated terphenyls (PCTs) and toxaphene (CTT) by comprehensive two-dimensional gas chromatography (GC x GC) were evaluated. Columns with different polarity and selectivity, including ZB-5, HT-8, DB-17 and BP-10, were selected as first dimension and combined with columns of increasing polarity in the second dimension, i.e. HT-8, BPX-50 and Carbowax (or Supelcowax-10). In total nine column combinations were tested. Because the main interest of the study was fast screening of the test xenobiotic families in complex matrices, in all cases, attention was primarily focussed on group-type separation. Nevertheless, within-group separation was also considered, especially for those classes containing particularly toxic congeners, such as PCBs and PCDD/Fs. Although none of the assayed column sets allowed the simultaneous and complete separation of all pollutants classes, some column combinations provided satisfactory separations among selected families and the rest of pollutants investigated. That was, for instance, the case of HT-8 x BPX-50 for PBDEs and PCDD/Fs, DB-17 x HT-8 for PCNs and OCPs and BP-10 x BPX-50 for CTT, PCDD/Fs and PBDEs. The feasibility of the proposed approach for the fast screening of the target classes of pollutants in complex samples was illustrated by the analysis of food and marine fat samples prepared using simplified miniaturised sample treatment methods.

项与 Claseprubart 相关的新闻（医药）

2025-12-29

·新药患者招募

新药招募 | 多灶性运动神经病（MMN）患者，创新生物制剂DNTH103注射液国际多中心II期研究开放报名

【您或您身边的人是否正面临以下困扰？】被诊断为一种罕见的周围神经疾病——多灶性运动神经病（MMN），主要影响肢体力量，特别是手部？目前依赖于静脉注射免疫球蛋白（IVIg）或皮下注射免疫球蛋白（SCIg）维持肌力，但面临频繁输液、携带不便或疗效波动等问题？期待有一种更便捷、更长效、或作用机制不同的创新治疗方案？如果您或您的家人正面临上述困境，一项全新的国际多中心临床研究可能为您带来新的选择。由元羿生物科技（上海）有限公司申办的创新生物制剂 DNTH103注射液 II期临床研究，正在包括中国在内的全球多个国家招募患者。该研究旨在评估这款每两周一次皮下注射的新药，在MMN患者中的安全性、耐受性及初步有效性，探索其作为潜在新疗法的可能性。🌟 患者获益与支持 🌟 参与本研究，您将获得以下支持与保障：免费治疗与检查：研究期间使用的试验药物DNTH103注射液或安慰剂，以及方案规定的所有与研究相关的检查、评估均免费。国际顶尖专家团队照护：您将在国内顶尖的神经疾病研究中心（如北京协和医院、宣武医院、华山医院等）接受由资深专家组成的团队进行的专业诊疗与严密随访。交通补贴：我们将为您提供一定的交通补贴，以减轻您定期往返研究中心的经济负担。贡献罕见病治疗进步：您的参与对于推进这种罕见神经系统疾病的新型治疗研究至关重要，您的贡献将为全球MMN患者带来新的希望。✅ 谁可以报名？（部分核心条件）如果您符合以下情况，可初步评估：入选标准（需同时满足）：年龄在18至75周岁（含）之间，体重在40-120公斤之间。根据国际指南（EFNS/PNS 2010）被确诊为“确诊的”或“很可能的”多灶性运动神经病（MMN）。必须对免疫球蛋白（IVIg或SCIg）治疗有反应，并有历史记录证明（如停药后恶化，恢复用药后改善）。在筛选前已接受稳定剂量和频率的免疫球蛋白治疗至少一段时间。愿意并能够遵守研究方案要求，完成所有访视和评估。❌ 谁可能不适合？（部分核心排除条件）为确保受试者安全与研究科学性，若您存在以下情况，可能无法参与：患有其他可能混淆评估的神经系统疾病（如慢性炎症性脱髓鞘性多发性神经病CIDP）、严重糖尿病神经病变、影响手部的关节炎等。已知有补体缺乏或系统性红斑狼疮（SLE）病史或家族史。筛选前特定时间内使用过某些免疫抑制剂（如利妥昔单抗、环磷酰胺等）或补体抑制剂。有活动性感染（如活动性结核）、活动性乙型肝炎、丙型肝炎或HIV感染。有脑膜炎球菌感染史，或未按方案要求接种相关疫苗。患有除MMN外的其他严重活动性自身免疫性疾病。研究者判断存在任何其他可能增加风险或干扰研究评估的严重医疗状况。📞 如何咨询与报名？本研究为国际多中心研究，在中国的主要研究中心如下。如果您初步符合上述条件并感兴趣，可以后台联系/扫描二维码添加进行详细咨询：国内主要参与中心（部分）：首都医科大学宣武医院（北京）中国医学科学院北京协和医院（北京）复旦大学附属华山医院（上海）请注意：最终能否入组，需由研究医生根据详细的病史回顾、体格检查、神经电生理等评估结果，并严格对照研究方案的所有标准进行审核后确定。咨询时，请尽可能准备好您既往的诊断证明、免疫球蛋白治疗记录及相关检查报告。⚠️ 重要知情提示自愿原则：参与临床研究完全基于您的自愿。您有权在任何阶段，因任何原因退出研究，这不会影响您后续获得常规医疗服务的权益。充分知情：在签署知情同意书前，研究医生会花费充足时间向您详细解释研究的目的、流程、可能的风险与获益、您的权利与责任等所有细节。请务必在完全理解并慎重考虑后再做决定。随机与盲法：本研究采用“随机、双盲”设计，这意味着您将被随机分配到接受试验药DNTH103或外观相同的安慰剂组，且您和研究医生在治疗期间都不知道具体分组情况。风险提示：DNTH103注射液仍处于临床研究阶段，其安全性和有效性尚未完全确立。治疗可能存在未知的风险或副作用。所有目前已知的潜在风险都将在知情同意过程中被明确告知。研究已为受试者购买保险，并设立独立的数据安全监查委员会（DMC）监督研究安全。扫描二维码，立即咨询&立即报名

临床2期

2025-10-22

·今日头条

维立志博与Dianthus Therapeutics签订全球独家许可协议

近日，江北新区南京生物医药谷园区企业维立志博股票代码：9887.HK）与致力于开发下一代严重自身免疫疾病疗法的临床阶段生物技术公司Dianthus Therapeutics（下称“Dianthus”，纳斯达克代码：DNTH）宣布达成独家全球合作伙伴关系，将共同推进新型抗BDCA2/TACI双特异性融合蛋白LBL-047（大中华区外由Dianthus Therapeutics开发为DNTH212）。目前，LBL-047已获美国新药临床试验（IND）许可及中国IND受理。 LBL-047是维立志博的临床前管线，作为一款同类首创（First-in-class）、长效双特异性融合蛋白，其设计通过选择性清除浆细胞样树突状细胞（pDCs）以降低I型干扰素（IFN-I）生成，同时抑制BAFF/APRIL信号通路来阻断B细胞活化、存活及抗体产生。通过靶向自身免疫疾病发病机制中的两个关键驱动因素，这一差异化策略有望覆盖多种自身免疫适应症，最大化其临床价值与商业潜力。根据协议条款，维立志博将授予Dianthus在大中华区以外独家研发、生产及商业化LBL-047的权益，获得最高3800万美元的首付款及近期里程碑付款，其中包括2000万美元首付款、2025年第四季度支付的500万美元，以及最高1300万美元的潜在近期里程碑付款。该交易总金额（含临床开发、监管及商业化里程碑）最高可达10亿美元。此外，维立志博还有权获得大中华区以外地区净销售额的分级特许权使用费，费率从中个位数至低双位数不等。维立志博创始人、董事长、CEO康小强博士表示很高兴能与Dianthus达成合作，该公司在开发变革性自身免疫疾病疗法领域具有公认的领导地位和深厚专长。此次合作不仅有助于我们推进解决严重自身免疫疾病的创新候选药物，同时进一步丰富了我们的管线布局，为维立志博的长期发展奠定坚实基础。 Dianthus首席执行官Marino Garcia表示我们非常高兴能与Leads Biolabs达成合作，通过将DNTH212纳入管线，进一步实现我们成为自身免疫领域领导者的愿景。Claseprubart和DNTH212均具有已验证的作用机制，且患者可通过皮下注射实现便捷给药，这两款药物有望显著改善多种严重自身免疫疾病患者的生活。我们期待充分释放DNTH212的治疗潜力。维立志博维立志博成立于2012年，是一家处于临床阶段的生物科技公司，致力于创新疗法的发现、开发及商业化，以满足中国及全球在肿瘤、自身免疫性疾病及其他重大疾病方面未获满足的医疗需求。公司拥有涵盖14款创新候选药物的差异化临床管线，其中6款已成功进入临床阶段，4款主要产品均处于全球临床进度领先的候选药物之列。其采用科学驱动的研发方法，已成功建立涵盖抗体发现及工程、体内及体外疗效评估以及成药性评估的综合研发能力。公司亦开发了包括LeadsBody™平台（CD3 T-Cell Engager平台）、X-body™平台（4-1BB Engager平台）、TOPiKinectics™（ADC技术平台）在内的专有技术平台。公司技术平台是我们持续创新的基石，并已通过双特异性抗体组合的临床结果得到验证，成功建立起了在早期研发、转化医学、临床开发、CMC以及业务拓展方面无缝衔接的自主能力。其候选药物的创新性质及竞争优势，配合全球视野、积极主动的策略及高效的临床验证使我们成为头部行业参与者及风险资本备受欢迎的合作伙伴。 Dianthus Therapeutics Dianthus Therapeutics是一家临床阶段的生物技术公司，致力于开发下一代严重自身免疫性疾病的变革性疗法。公司总部位于纽约市和马萨诸塞州沃尔瑟姆，由一支经验丰富的生物技术与制药行业高管团队组成，旨在为患有严重自身免疫性和炎症性疾病的患者提供变革性药物。

引进/卖出临床申请临床1期临床终止免疫疗法

2025-10-17

·GlobeNewswire-Health Care

Dianthus Therapeutics Announces Exclusive License Agreement with Leads Biolabs for DNTH212, a First and Potentially Best-In-Class, Phase 1 Ready Bifunctional BDCA2 & BAFF/APRIL Inhibitor for Severe Autoimmune Diseases

DNTH212 is a bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function Demonstrated superior inhibition of pDCs vs. litifilimab in vitro and superior Ig reductions vs. povetacicept in NHPs highlight the potential for improved clinical benefit in severe autoimmune diseases DNTH212 has the potential to be a first line biologic in multiple autoimmune disorders with patient-friendly S.C. self-administration and Q4W or less frequent dosing IND cleared by FDA in September 2025 and expected to clear in China in Q4’25. Phase 1 study of DNTH212 expected to initiate in Q4’25 with top-line results in healthy volunteers in 2H’26 Pro forma estimated cash of ~$525 million; reaffirms runway into 2028 Investor conference call and webcast to be held today at 8:00 a.m. ET Oct. 16, 2025 -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today announced it has entered into an exclusive licensing agreement with Nanjing Leads Biolabs Co., Ltd. (“Leads” (9887.HK) for DNTH212 (being developed in China by Leads Biolabs as LBL-047), a first and potentially best-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor. DNTH212 is an investigational, extended half-life bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. By targeting both the innate and adaptive immune systems via two clinically validated pathways that are known drivers of autoimmune disease pathogenesis, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes. “We are excited to partner with Leads Biolabs and build upon our vision of becoming a leading autoimmune-focused biopharmaceutical company with the addition of DNTH212 to our pipeline,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “Both claseprubart and DNTH212, with their validated mechanisms of action and patient friendly convenience of infrequent S.C. self-administration, have the potential to significantly improve the lives of patients suffering from a range of severe autoimmune disorders. We look forward to leveraging the pipeline-in-a-product potential of DNTH212.” pDCs are specialized immune cells that produce large amounts of Type 1 interferons (IFN- and IFN-). High levels of Type 1 interferon drive chronic inflammation and tissue damage, making Type 1 interferon inhibition a promising therapeutic strategy in multiple autoimmune diseases. DNTH212 demonstrated comparable IFNα inhibition and superior pDC depletion in-vitro compared to litifilimab, a late-stage clinically validated BDCA2 monoclonal antibody. BAFF/APRIL activation of B cells generate autoantibodies against tissues that trigger inflammation and tissue damage. Inhibiting BAFF/APRIL has been shown to be a clinically validated therapeutic strategy in numerous autoimmune diseases. DNTH212 demonstrated superior inhibition of immunoglobulins (i.e. IgM, IgA, and IgG) in non-human primates compared to povetacicept, a late-stage clinically validated BAFF/APRIL inhibitor. “The medical team is ready to exploit the full potential of this unique asset targeting both the innate and adaptive immune systems,” said Dr. Simrat Randhawa, Head of Research & Development of Dianthus Therapeutics. “Autoimmune experts have been asking for combination biologic approaches for years so we expect an enthusiastic reception from them as we roll out our target indications.” A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) is expected to initiate by year end 2025, with top-line results in healthy volunteers expected in the second half of 2026. “We are pleased to partner with Dianthus, a leading biotechnology company with a proven track record of executing complex global clinical trials and delivering meaningful results for patients,” said Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs. “This collaboration reinforces our commitment to advancing highly innovative drug candidates into the clinic to address serious autoimmune conditions, while further diversifying our pipeline and positioning Leads Biolabs for long-term growth. Dianthus’ deep experience and expertise in this space will be invaluable as we work to bring LBL-047 to patients worldwide.” Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who aim to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company developing innovative therapies for underserved medical needs in oncology, autoimmune, and other severe diseases in China and globally. A front-runner in next-generation immuno-oncology, the company has a pipeline of 14 drug candidates, including six clinical-stage programs, four of which are among the most advanced in their class. Leads Biolabs leverages proprietary platforms, including LeadsBody™ (CD3 T-cell engager) and X-body™ (4-1BB engager), along with integrated capabilities across discovery, translational medicine, clinical development, CMC, and business development. The innovative nature and competitive strengths of its drug candidates, combined with a proactive strategy, efficient clinical validation, and global perspective, position Leads Biolabs as a preferred partner for leading biopharmaceutical companies and venture capital investors. The content above comes from the network. if any infringement, please contact us to modify.

引进/卖出免疫疗法

100 项与 Claseprubart 相关的药物交易

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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
慢性炎症性脱髓鞘性多发性神经病	临床3期	美国	Dianthus Therapeutics, Inc.	2025-02-10
慢性炎症性脱髓鞘性多发性神经病	临床3期	中国	Dianthus Therapeutics, Inc.	2025-02-10
慢性炎症性脱髓鞘性多发性神经病	临床3期	阿根廷	Dianthus Therapeutics, Inc.	2025-02-10
慢性炎症性脱髓鞘性多发性神经病	临床3期	澳大利亚	Dianthus Therapeutics, Inc.	2025-02-10
慢性炎症性脱髓鞘性多发性神经病	临床3期	巴西	Dianthus Therapeutics, Inc.	2025-02-10
慢性炎症性脱髓鞘性多发性神经病	临床3期	保加利亚	Dianthus Therapeutics, Inc.	2025-02-10
慢性炎症性脱髓鞘性多发性神经病	临床3期	哥伦比亚	Dianthus Therapeutics, Inc.	2025-02-10
慢性炎症性脱髓鞘性多发性神经病	临床3期	丹麦	Dianthus Therapeutics, Inc.	2025-02-10
慢性炎症性脱髓鞘性多发性神经病	临床3期	法国	Dianthus Therapeutics, Inc.	2025-02-10
慢性炎症性脱髓鞘性多发性神经病	临床3期	德国	Dianthus Therapeutics, Inc.	2025-02-10

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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


NCT06282159 (MAGIC, GlobeNewswire) 人工标引	临床2期	重症肌无力 AChR antibody positive	65	Claseprubart 300 mg	糧鹹憲夢艱簾願醖淵鑰(遞鏇網窪蓋範積遞憲鑰) = Claseprubart was generally well tolerated and demonstrated a clinical safety profile in both treatment arms comparable to placebo. No infection signal was observed, including no related serious bacterial infections in the treatment arms; the only related serious adverse event (SAE) of infection occurred in the placebo arm. There were no symptoms indicative of autoimmune activation. Injection site reactions (ISRs) were infrequent and generally mild, and there were no claseprubart discontinuations from RCT due to related AEs. 齋窪艱夢範夢鑰鹹夢遞 (構窪艱壓構餘網襯鑰獵 )	积极	2025-09-08
				Claseprubart 600 mg