A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

开始日期2024-11-21

申办/合作机构

UCB Biopharma SRL

NCT04976322

/ Enrolling by invitation临床3期

A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus

The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.

开始日期2021-07-27

申办/合作机构

UCB Biopharma SRL

NCT04571424

/ Completed临床1期

Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Dapirolizumab Pegol (BIIB133) in Healthy Japanese and Caucasian Study Participants

The primary objective of the study is to assess the safety and tolerability of a single intravenous (IV) dose of dapirolizumab pegol (DZP) in Japanese healthy study participants compared with those of Caucasian healthy study participants.
The secondary objectives of the study are to assess the pharmacokinetic(s) (PK) of a single IV dose of DZP in Japanese and Caucasian healthy study participants, to evaluate ethnic sensitivity on the PK of DZP between body weight- and gender-matched Japanese and Caucasian healthy study participants and to evaluate the immunogenicity of a single IV dose of DZP in Japanese and Caucasian healthy study participants.

开始日期2020-10-14

申办/合作机构

Biogen, Inc.

100 项与 Dapirolizumab pegol 相关的临床结果

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100 项与 Dapirolizumab pegol 相关的转化医学

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100 项与 Dapirolizumab pegol 相关的专利（医药）

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489

项与 Dapirolizumab pegol 相关的文献（医药）

2026-03-01·NEUROTOXICOLOGY

Targeting glutamate receptors with IEM-1925: A strategy against soman-induced status epilepticus and neurodegeneration

Article

作者: Wang, Jingyan ; Cao, Manzhu ; Li, Liqin ; Zhang, Yi ; Shi, Jingjing ; Lin, Yuxin ; Jin, Qian ; Chen, Yuanqing

Exposure to organophosphorus nerve agents (OPNAs) like soman frequently develops status epilepticus (SE), leading to brain damage. Existing antiseizure medications (e.g., diazepam, DZP) often demonstrate insufficient efficacy. To develop more effective treatments for OPNA-induced seizures, this study evaluated the efficacy of glutamate receptor antagonists with distinct mechanisms of action in a soman-induced rat seizure model. After 5 min of subcutaneous exposure to 110 μg/kg soman, which induced SE, rats received intraperitoneal injections (10 mg/kg) of perampanel (PER), fanapanel (FNP), IEM-1925 (IEM), or DZP. The results showed that IEM significantly suppressed seizure activity and improved survival. The survival rate of the vehicle-treated control group was 31.25 %, whereas DZP, FNP, and IEM increased survival rates to 50 %, 43.75 %, and 56.25 % respectively. Electroencephalographic (EEG) recordings for 24 h indicated that both DZP and IEM controlled soman-induced SE. However, while DZP initially blocked the onset of seizures, they recurred after its transient anticonvulsant effect wore off. In contrast, IEM reduced behavioral convulsion intensity and total duration of SE. Histopathological examinations (HE, Nissl, immunohistochemistry, and immunofluorescence) showed that IEM attenuated hippocampal CA1, CA2, and DG neuronal damage. Behavioral tests (open field, novel object recognition, and Y maze) confirmed IEM outperformed DZP and the solvent-treated group in ameliorating soman-induced anxiety, cognitive dysfunction, and memory impairment. In conclusion, IEM demonstrates potent triple effects-antiseizure, neuroprotective, and cognitive improving in soman exposure model, providing a novel therapeutic strategy and candidate drug for the medical treatment of OPNAs poisoning.

2026-02-01·EUROPEAN JOURNAL OF IMMUNOLOGY

Curbing Autoimmunity: A New Fab Fragment Targeting CD40‐CD40L Halts B‐Cell Activation and Differentiation

Article

作者: Thiel, Steffen ; Andersen, Ebbe S. ; Valero, Julián ; Troldborg, Anne ; Schinkel, Thea ; Pedersen, Kathrine ; Green, Kenneth ; Kristoffersen, Emil L. ; Rovsing, Anne B. ; Laursen, Nick S. ; Degn, Søren E. ; Palarasah, Yaseelan ; Hansen, Annette G. ; Civit, Laia

ABSTRACT:

Dysregulation of the CD40‐CD40L axis is implicated in autoimmune diseases. Early clinical trials targeting CD40L with antibodies failed due to Fc‐mediated side effects. To address this, we developed an anti‐CD40L Fab fragment, Fab20, designed to block B‐cell activation. Fab20 was evaluated for its binding properties, CD40‐CD40L inhibition, and effects on human B‐cell activation and differentiation using immunoassays, cryo‐electron microscopy, flow cytometry, and cell cultures. Fab20 binds CD40L with a dissociation constant of 70 nM. Structural analysis revealed a “propeller‐like” structure consisting of three Fabs binding to the CD40L trimer, sterically blocking parts of the CD40 binding site. Fab20 effectively inhibited B‐cell activation, maintaining naïve B cells in their inactive state, and suppressed antibody (IgG) production over 14 days. Fab20 represents a promising novel therapeutic approach for treating autoimmune diseases driven by CD40‐CD40L dysregulation. Its mechanism of action, coupled with the absence of Fc‐mediated effects, suggests a favorable safety profile.

2026-02-01·JOURNAL OF FOOD SCIENCE

Modulation of DBS/Zein/Pectin Nanoparticle Properties by Calcium Ions: Physicochemical and Emulsifying Insights

Article

作者: Zhang, Biao ; Jiang, Jinchi ; Cui, Jie ; Zhang, Rongrong ; Li, Wenhui ; Yang, Wenge ; Hu, Yonghong ; Zhang, Jian

ABSTRACT:

This study investigated the effects of Ca 2+ ions on the physicochemical properties of DBS/zein/pectin (DZP) ternary composite nanoparticles by adding varying concentrations of Ca 2+ during particle formation. Ca 2+ ions reduced electrostatic repulsion between colloidal particles, causing collisions and aggregation, which increased particle size. Additionally, Ca 2+ ions decreased α‐helices and increased β‐sheets in the zein molecular chains, weakening interactions between zein and other components, and reducing the thermal stability of the composite particles. At high Ca 2+ concentrations, phase separation occurred, with the crystalline structure nearly disappearing. Ca 2+ ions neutralized surface charges, decreased colloidal particle wettability, and reduced emulsifying capacity. Emulsions prepared with these particles showed that Ca 2+ addition intensified the aggregation of composite particles on the emulsion droplet surface, resulting in pronounced phase separation and reduced emulsion stability. Overall, these results demonstrate that Ca 2+ plays a key regulatory role in governing the structure–property relationships of DZP ternary composite nanoparticles. This study provides mechanistic insight into ion‐mediated regulation of protein–polysaccharide systems and highlights the potential of DZP nanoparticles as calcium‐responsive carriers for food‐related delivery applications.

105

项与 Dapirolizumab pegol 相关的新闻（医药）

2026-04-07

·百度百家

CD40LG：从免疫缺陷到肿瘤免疫，一文讲透这个关键共刺激分子

CD40LG（CD154）是TNF超家族中的重要共刺激分子，在T细胞依赖性B细胞活化、抗体类别转换和免疫记忆形成中发挥核心作用。本文系统综述了CD40LG-CD40信号轴的分子机制，重点阐述了其在NF-κB、JAK-STAT通路及非编码RNA调控中的功能，并梳理了该信号异常与X-连锁高IgM综合征（XHIGM）、自身免疫病（如类风湿关节炎、系统性红斑狼疮）、急性肝损伤及动脉粥样硬化等疾病的关系，旨在为CD40LG相关疾病的机制研究与精准治疗提供参考。 1. CD40LG 概述 2. CD40LG 的作用机制与信号通路 3. CD40LG 相关疾病 4. CD40-CD40LG 轴的药物研究进展 5. CD40LG 相关研究工具 1. CD40LG 概述 CD40LG（又称 CD154）是免疫系统中的关键共刺激分子，属于肿瘤坏死因子（TNF）超家族。它通常以三聚体形式与 CD40 结合，在 T 细胞依赖性 B 细胞活化、抗体类别转换和免疫记忆形成中发挥重要作用 [1]。早期研究主要关注其在活化 CD4+ T 细胞中的表达，但后续研究表明，CD40LG 也可见于血小板、B 细胞、内皮细胞和巨噬细胞等多种细胞，其中血小板是循环可溶性 CD40LG 的主要来源 [1,2]。 CD40LG-CD40 轴不仅参与正常免疫应答，也与多种疾病密切相关。CD40LG 功能缺陷可导致 X-连锁高 IgM 综合征（XHIGM），引起抗体类别转换障碍和感染易感性增加 [3,4]；该通路的异常激活还参与自身免疫、炎症反应、动脉粥样硬化及肿瘤免疫调控等过程 [1,18,21]。此外，CD40LG 的作用具有明显的细胞类型和疾病背景依赖性，在不同微环境中可表现为促炎、免疫支持或免疫抑制效应 [6,7]。因此，系统梳理 CD40LG 的分子特征、信号机制、疾病关联及药物研究进展，对于理解其生物学功能和临床转化价值具有重要意义。 2. CD40LG 的作用机制与信号通路 2.1 经典信号通路：NF-κB 与 JAK-STAT CD40-CD40LG 结合后可激活多条经典下游通路，其中最重要的是 NF-κB 和 JAK-STAT。该信号轴可参与细胞增殖、分化、细胞因子产生及凋亡调控。研究表明，CD40 可通过激活 JAK-STAT 通路抑制乙肝病毒复制和转录，并进一步调节 BST2 等干扰素刺激基因的表达，提示其在抗病毒免疫中具有重要作用 [8]。此外，NF-κB 与凋亡相关信号也与 CD40LG 密切相关；在肺炎治疗机制研究中，CD40LG 被确定为 NF-κB 和凋亡通路中的关键靶点 [9]。 2.2 miRNA 调控：影响炎症、血管生成与白血病信号应答除经典蛋白信号外，miRNA 也是调控 CD40/CD40LG 轴的重要层面。研究发现，miR-424 和 miR-503 可直接靶向 CD40 的 3'UTR，抑制其在内皮细胞中的表达 [10]。在促炎刺激下，这两种 miRNA 下调，导致 CD40 表达上升，从而促进炎症相关血管生成。进一步来看，miR-424 和 miR-503 又受 PPARγ 直接调控，因此形成了 PPARγ 依赖的 miR-424/503-CD40 轴 [10]。在慢性淋巴细胞白血病中，miR-29 家族也参与 CD40 信号调节。miR-29a、miR-29b 和 miR-29c 的下调，可通过直接靶向 TRAF4，增强 CLL 细胞对 CD40 激活及其下游 NF-κB 信号的反应 [11]。同时，BCR 信号可通过 MYC 抑制 miR-29 表达，进而强化 CD40-NF-κB 信号，这一调控过程可被伊布替尼和 Idelalisib 等 BCR 抑制剂干预 [11]。 2.3 lncRNA 与 ceRNA 机制：扩展 CD40 调控网络长链非编码 RNA 也参与 CD40 轴调控。例如，lncRNA MSTRG.22719.16 可通过 ceRNA 机制与 ocu-miR-326-5p 相互作用，进而调控 CD40 表达。在 PMMA 骨水泥诱导的局部血栓形成中，MSTRG.22719.16/ocu-miR-326-5p/CD40 轴的活化可减少血栓形成，提示其具有潜在干预价值 [12]。总体来看，CD40-miRNA 轴在细胞命运决定和病理状态调节中具有重要意义 [13]，但其系统性机制仍有待进一步研究。 3. CD40LG 相关疾病 CD40LG 功能异常与多种疾病相关，包括原发性免疫缺陷、自身免疫与炎症性疾病，以及肿瘤。不同疾病中，该分子的作用方向和强度受细胞来源与微环境影响明显。 3.1 X-连锁高 IgM 综合征（XHIGM） XHIGM 是 CD40LG 缺陷最典型的疾病类型。患者常出现反复感染，病原体既包括常见细菌，也包括卡氏肺孢子虫、隐孢子虫、马尔尼菲篮状菌、巨细胞病毒和腺病毒等机会性感染或病毒感染 [3,14,15]。呼吸道和胆道系统是常见受累部位，部分患者还可能以间质性肺炎或肺泡蛋白沉积症为首发表现 [16, 17]。此外，患者还可伴随自身免疫和炎症性并发症，增加预后风险 [18]。 CD40LG 基因突变类型与临床表型密切相关。部分错义突变可保留 CD40L 表达，但削弱其与 CD40 的结合能力，从而形成相对较轻或非典型表型 [4]；而截短突变通常提示更严重的功能缺陷 [17]。诊断上，XHIGM 并不能仅依赖免疫球蛋白谱，因为部分患者可呈现非典型血清学特征。结合基因检测、流式细胞术及 CD40 结合功能分析，才能更准确地识别这类患者 [4, 15]。 3.2 自身免疫与炎症性疾病在类风湿关节炎中，CD40LG 被认为具有潜在生物标志物价值。研究显示，RA 患者血清中 CD40LG 抗体水平升高，尤其在伴有间质性肺病或严重骨破坏者中更为明显，提示其可能与疾病活动度和并发症风险相关 [19]。在系统性红斑狼疮中，CD40LG-CD40 轴异常活化可促进 B 细胞活化和自身抗体生成，是重要的致病机制之一 [20]。针对该通路的阻断策略已在动物模型中显示出缓解狼疮性肾炎和整体自身免疫症状的潜力 [20]。在急性肝损伤中，IFNγ-CD40 轴与肝内微循环障碍密切相关。IFNγ 可上调内皮细胞 CD40 表达，促进其与 CD40LG 相互作用，诱导组织因子表达并加重凝血和肝损伤 [21]。在动脉粥样硬化中，CD40LG 的作用则表现出细胞来源差异：T 细胞来源的 CD40L 更影响斑块形成和稳定性，而血小板来源的 CD40L 对血栓形成更重要 [1]。此外，在 HBV 清除、局部血栓形成及过敏原耐受等场景中，CD40/CD40LG 轴也发挥重要调节作用 [6,8,12]。 3.3 肿瘤发生与进展 CD40LG 在肿瘤中的作用具有双重性。以乳腺癌为例，其在肿瘤组织中的低表达与更晚期分期和更差预后相关，同时与多种免疫细胞浸润显著相关，提示其可能参与肿瘤免疫微环境塑造 [21]。在泛癌种分析中，CD40LG 还被视为 T 细胞启动标志物，其表达与 MSI-H、高 TMB 和 PD-L1 高表达等免疫治疗相关特征呈正相关 [22]。在特定肿瘤中，CD40LG 还参与疾病进展机制。例如，在 T-ALL 中，BACH2 可通过抑制 CD28 和 CD40LG 表达影响肿瘤细胞存活和增殖 [23]；在 Waldenström 巨球蛋白血症中，CD40/CD40L 轴可支持 Treg 介导的免疫抑制微环境 [7]；在部分 T 细胞淋巴瘤及口腔鳞癌相关研究中，CD40LG 也被提示参与肿瘤维持或药物响应 [24-26]。 4. CD40-CD40LG 轴的药物研究进展围绕 CD40-CD40LG 轴的药物开发主要分为两类：一类是抑制该通路，用于自身免疫病、移植排斥等场景；另一类是激活该通路，以增强抗肿瘤免疫。目前，靶向CD40L的药物研发进展迅速，多种药物类型（包括融合蛋白、单克隆抗体、溶瘤病毒、小分子化药及治疗性疫苗等）已在自身免疫性疾病、器官移植排斥反应及多种恶性肿瘤等领域进入临床研究阶段，部分候选药物已推进至临床3期。下表汇总了代表性在研管线的相关信息：药物靶点药物类型在研适应症（疾病名）在研机构最高研发阶段 Dazodalibep CD40L 融合蛋白干燥综合征 | 狼疮性肾炎 | 局灶性节段性肾小球硬化症 Amgen, Inc. | The Ohio State University Wexner Medical Center | Horizon Therapeutics Ltd. (Ireland) 临床3期 Dapirolizumab pegol CD40L 单克隆抗体系统性红斑狼疮 Biogen, Inc. | UCB Biopharma SRL | 优时比贸易（上海）有限公司 | UCB SA 临床3期 Frexalimab CD40L 单克隆抗体多发性硬化症 | 继发进展型多发性硬化 | 复发性多发性硬化 | 肾移植排斥反应等 Sanofi | Sanofi-Aventis Recherche & Développement SA | ImmuNext, Inc. 临床3期 Tegoprubart CD40L 单克隆抗体免疫球蛋白a肾病 | 肾移植排斥反应 | 肌萎缩侧索硬化 | 心脏移植排斥反应 ALS Therapy Development Foundation, Inc. | Eledon Pharmaceuticals, Inc. 临床2期 Delolimogene mupadenorepvec 4-1BBL x CD40L 溶瘤病毒胆道癌 | 胰腺导管腺癌 Uppsala University Hospital | Lokon Pharma AB 临床2期 OPT-101 CD40L 小分子化药社区获得性肺炎 | 脓毒症 OP LLC 临床2期 TriMixDC CD40L x CD70 x TLR4 治疗性疫苗 | 树突状细胞疫苗黑色素瘤 - 临床2期 TNX-1500 CD40L 单克隆抗体免疫抑制 | 肾移植排斥反应 | 自身免疫性疾病 | 器官移植排斥 Tonix Pharmaceuticals Holding Corp. | Tonix Pharmaceuticals, Inc. 临床2期 Bria-OTS CD40L x CD80 x CD86 x CSF-3R x Type I IFN Receptor x IL-12R x IL-7Rα 治疗性疫苗复发性乳腺癌 | 乳腺癌 BriaCell Therapeutics Corp. 临床1/2期 Adze1.C(Adze Biotechnology) CD40L 溶瘤病毒黑色素瘤 | 转移性黑色素瘤 | 膀胱癌 | 胶质母细胞瘤 | 肝癌 | 三阴性乳腺癌 Adze Biotechnology, Inc. | Adze Biotechnology Australia Pty Ltd 临床1期（数据截止到2026年3月19日，来源于synapse） 5. CD40LG 相关研究工具 CD40LG 是适应性免疫调控中的关键分子，在 B 细胞活化、抗体类别转换和免疫记忆形成中发挥核心作用。其功能异常与 XHIGM、自身免疫病、炎症性疾病和肿瘤密切相关 [3,18,21]。同时，CD40LG 兼具疾病标志物和治疗靶点的双重潜力，在精准医学中的价值正不断受到重视。CUSABIO 提供 CD40LG 重组蛋白、抗体及 ELISA 试剂盒产品，助力您进行相关机制研究及靶向药物开发。 ● CD40LG 重组蛋白 Recombinant Human CD40 ligand (CD40LG), partial (Active); CSB-MP004937HU3 Recombinant Mouse CD40 ligand (Cd40lg), partial (Active); CSB-MP004937MO1 ● CD40LG 抗体 CD40LG Antibody CSB-PA06005A0Rb CD40LG Antibody CSB-PA004937GA01HU ● CD40LG ELISA 试剂盒 Human Soluble Cluster of differentiation 40 ligand,sCD40L ELISA Kit CSB-E04716h Rat Soluble Cluster of differentiation 40 ligand,sCD40L ELISA Kit CSB-E07395r Mouse Soluble Cluster of differentiation 40 ligand,sCD40L ELISA Kit CSB-E04717m 参考文献： [1] M. Lacy, C. Bürger, Annelie Shami, M. Ahmadsei, H. Winkels, K. Nitz, C. van Tiel, T. Seijkens, Pascal J. H. Kusters, Ela Karshovka, K. Prange, Yuting Wu, S. Brouns, Sigrid Unterlugauer, Marijke J. E. Kuijpers, M. Reiche, S. Steffens, A. Edsfeldt, R. Megens, J. Heemskerk, I. Gonçalves, C. Weber, N. Gerdes, D. Atzler, E. Lutgens. (2021). Cell-specific and divergent roles of the CD40L-CD40 axis in atherosclerotic vascular disease. [2] C. Aloui, Antoine Prigent, S. Tariket, C. Sut, Jocelyne Fagan, F. Cognasse, T. Chakroun, O. Garraud, S. Laradi. (2016). Levels of human platelet-derived soluble CD40 ligand depend on haplotypes of CD40LG-CD40-ITGA2. [3] B. Neven, F. Ferrua. (2020). Hematopoietic Stem Cell Transplantation for Combined Immunodeficiencies, on Behalf of IEWP-EBMT. [4] T. Nishikawa, Dan Tomomasa, Atsushi Hijikata, Hiroshi Kasabata, Yasuhiro Okamoto, H. Ochs, H. Kanegane. (2025). Case Report: CD40LG Arg203Ile variant underlies atypical phenotype of X-linked hyper IgM syndrome. [5] K. Antoniou, F. Ender, T. Vollbrandt, Y. Laumonnier, Franziska Rathmann, C. Pasare, Harinder Singh, J. Köhl. (2020). Allergen-Induced C5a/C5aR1 Axis Activation in Pulmonary CD11b+ cDCs Promotes Pulmonary Tolerance through Downregulation of CD40. [6] A. Sacco, V. Desantis, J. Celay, V. Giustini, Fabio Rigali, Francesco D Savino, M. Cea, D. Soncini, A. Cagnetta, Antonio Giovanni Solimando, D. D'Aliberti, S. Spinelli, Daniele Ramazzotti, C. Almici, K. Todoerti, A. Neri, A. Anastasia, A. Tucci, M. Motta, M. Chiarini, Y. Kawano, Jose-Al Martinez-Climent, R. Piazza, A. Roccaro. (2023). Targeting the immune microenvironment in Waldenström Macroglobulinemia via halting the CD40/CD40-ligand axis. [7] Jiaxuan Chen, Haitao Chen, Haoming Mai, Shuang Lou, Mengqi Luo, Haisheng Xie, Bin Zhou, J. Hou, Deke Jiang. (2022). A functional variant of CD40 modulates clearance of hepatitis B virus in hepatocytes via regulation of the ANXA2/CD40/BST2 axis. [8] Liping Sun, Dandan Wang, Yan Xu, Wenxiu Qi, Yanbo Wang. (2020). Evidence of TCM Theory in Treating the Same Disease with Different Methods: Treatment of Pneumonia with Ephedra sinica and Scutellariae Radix as an Example. [9] . (2017). A PPARγ-dependent miR-424/503-CD40 axis regulates inflammation mediated angiogenesis. [10] Sonali Sharma, G. Pavlasová, V. Seda, K. Černá, E. Vojáčková, D. Filip, L. Ondrisova, Veronika Šandová, L. Košťálová, P. F. Zeni, M. Borsky, J. Oppelt, K. Lišková, L. Křen, A. Janíková, Š. Pospíšilová, S. Fernandes, M. Shehata, U. Jaeger, M. Doubek, M. Davids, Jennifer R. Brown, J. Mayer, T. Kipps, M. Mraz. (2020). miR-29 Modulates CD40 Signaling in Chronic Lymphocytic Leukemia by Targeting TRAF4: an Axis Affected by BCR inhibitors. [11] Linchao Sang, Luobin Ding, Kangning Hao, Ce Zhang, Xiaoyu Shen, Hui Sun, Dehao Fu, Xiangbei Qi. (2023). LncRNA MSTRG.22719.16 mediates the reduction of enoxaparin sodium high-viscosity bone cement-induced thrombosis by targeting the ocu-miR-326-5p/CD40 axis. [12] S. Salunkhe, Tushar Vaidya. (2020). CD40-miRNA axis controls prospective cell fate determinants during B cell differentiation. [13] H. Fan, Li Huang, Diyuan Yang, Changhao Zhang, Q. Zeng, G. Yin, G. Lu, Kunling Shen. (2022). Respiratory infections in X-linked hyper-IgM syndrome with CD40LG mutation: a case series of seven children in China. [14] A. Khojah, L. Gunderman, Mohammad Binhussein, A. Bukhari, Imad Khojah. (2023). A Case Report of Hyper-IgM Syndrome Patient with Normal Serum IgA Level. [15] Tianliu Wang, Li-Fang Wu, Junguo Chen, Wen Zhu, Hua Wang, Xiao-Lin Liu, Yi-qun Teng. (2019). X-linked hyper-IgM syndrome complicated with interstitial pneumonia and liver injury: a new mutation locus in the CD40LG gene. [16] Hong-bo Xu, Maolin Tian, Yong-hua Bai, X. Ran, Lei Li, Yan Chen. (2023). CD40LG-associated X-linked Hyper-IgM Syndrome (XHIGM) with pulmonary alveolar proteinosis: a case report. [17] W. Rae, D. Ward, C. Mattocks, Yifang Gao, R. Pengelly, Sanjay Patel, S. Ennis, S. Faust, Anthony P. Williams. (2017). Autoimmunity/inflammation in a monogenic primary immunodeficiency cohort. [18] Chuanhui Yao, Hui Xu, Xun Gong, Xieli Ma, Yuchen Yang, Dan Dou, Qiu-wei Peng, Juan Jiao, Xiaopo Tang, Quan Jiang, Congmin Xia. (2025). CD40LG as a Biomarker in Rheumatoid Arthritis: Links to Bone Destruction and Interstitial Lung Disease ‐ A Bioinformatic Analysis With Clinical Validation. [19] Tian-Liang Fang, Baoqi Li, Meng Li, Yu-long Zhang, Zhang Jing, Yuan Li, Tianyuan Xue, Zhirang Zhang, Wen-li Fang, Zhongda Lin, Fanqiang Meng, Liyan Li, Yang Yang, Xingding Zhang, Xin Liang, Shu-Na Chen, Jun Chen, Xudong Zhang. (2023). Engineered Cell Membrane Vesicles Expressing CD40 Alleviate System Lupus Nephritis by Intervening B Cell Activation. [20] M. Kurokawa, T. Goya, M. Kohjima, Masatake Tanaka, Sadahiro Iwabuchi, Shigeyuki Shichino, S. Ueha, Tomonobu Hioki, Tomomi Aoyagi, Masaki Kato, Kouji Matsushima, Yoshihiro Ogawa. (2024). Microcirculatory disturbance in acute liver injury is triggered by IFNγ-CD40 axis. [21] Manqiu Yuan, Jianying Pei, Ruihao Li, Lirong Tian, Xin-bin He, Yanping Li. (2021). CD40LG as a Prognostic Molecular Marker Regulates Tumor Microenvironment Through Immune Process in Breast Cancer. [22] H. Miyashita, R. Kurzrock, N. Bevins, Kartheeswaran Thangathurai, Suzanna Lee, S. Pabla, M. Nesline, S. Glenn, J. Conroy, P. DePietro, E. Rubin, J. Sicklick, S. Kato. (2023). T-cell priming transcriptomic markers: implications of immunome heterogeneity for precision immunotherapy. [23] Min Feng, Bailing Zhang, Guilan Li, Yan Yang, Jiangyuan Liu, Ziting Zhang, Bing Zhou, Han Zhang. (2024). BACH2-mediated CD28 and CD40LG axes contribute to pathogenesis and progression of T-cell lymphoblastic leukemia. [24] M. Fujisawa, Tran Bich Nguyen, Yoshiaki Abe, Y. Suehara, K. Fukumoto, S. Suma, K. Makishima, C. Kaneko, Yen Thi Minh Nguyen, K. Usuki, K. Narita, K. Matsue, N. Nakamura, S. Ishikawa, F. Miura, Takashi Ito, A. Suzuki, Yutaka Suzuki, S. Mizuno, Satoru Takahashi, S. Chiba, M. Sakata-Yanagimoto. (2022). Clonal germinal center B cells function as a niche for T-cell lymphoma. [25] Sofia Papadakos, Hawraa Issa, Abdulaziz Alamri, Abdullah Alamri, A. Semlali. (2024). Rapamycin as a Potential Alternative Drug for Squamous Cell Gingiva Carcinoma (Ca9-22): A Focus on Cell Cycle, Apoptosis and Autophagy Genetic Profile. [26] E. Fukutani, P. I. Ramos, J. I. Kasprzykowski, L. G. Azevedo, M. Rodrigues, J. Lima, Helton Fábio Santos de Araújo Junior, K. Fukutani, A. T. D. de Queiroz. (2019). Meta-Analysis of HTLV-1-Infected Patients Identifies CD40LG and GBP2 as Markers of ATLL and HAM/TSP Clinical Status: Two Genes Beat as One.

2026-03-30

·BioSpace

Biogen’s Lupus Drug Reduces Disease Activity, Further Deresking I&I Pipeline

iStock, Chee Siong Teh William Blair hailed a positive readout in cutaneous lupus erythematosus as a turning point for Biogen, while RBC Capital analysts called the results “another derisking step” for the company’s immunology and inflammation pipeline. Biogen’s litifilimab reduced disease activity in cutaneous lupus erythematosus in a second mid-stage study, providing another derisking step for the company’s immunology and inflammation (I&I) pipeline, according to analysts at RBC Capital Markets. “We believe this should underscore the promise of [Biogen’s] I&I pipeline,” the analysts said in a Sunday note to investors. Litifilimab—also known as liti—met the Phase 2/3 AMETHYST trial’s primary endpoint, showing an 11.8% higher reduction in disease activity in people with cutaneous lupus erythematosus (CLE) as measured by the Cutaneous Lupus Activity Investigators’ Global Assessment Revised (CLA-IGA-R) erythema score of 0-1 (clear/almost clear) at week 16 compared to placebo. Specifically, 14.7% of patients treated with liti achieved this target versus just 2.9% of patients on placebo, Biogen reported at the 2026 American Academy of Dermatology Annual Meeting on Saturday. Treatment with liti was also “associated with rapid and continued improvement in skin disease activity with separation from placebo observed as early as Week 4,” according to Biogen’s press release , with a score of 40.8% vs. 21.0% as measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity-50 (CLASI-50) through week 24. Notably, 16.3%—or 1 in 6—of liti recipients experienced no or minimal disease activity at week 24 compared to none of the placebo recipients. CLE is a serious autoimmune disease that causes skin rashes that can lead to permanent scarring and disfigurement, Diana Gallagher, senior vice president of Biogen’s Multiple Sclerosis and Immunology Disease Unit and Alzheimer’s and Dementia Disease Unit, told BioSpace. Diana Gallagher/ copyright David A. White AMETHYST’s results back an earlier successful Phase 2 trial, dubbed LILAC, in which liti showed a 22%–25% placebo-adjusted advantage at week 16 on the CLASI-50 in patients with CLE, according to RBC. The analysts called the drug’s consistent activity in this metric “encouraging.” Liti’s safety pro consistent with prior studies, Biogen reported. Next up in CLE, a one-year Phase 3 study is expected to produce topline data later next year, according to Gallagher. This trial will allow the company to “fully characterize safety and tolerability, time to effect and durability,” she said, adding that these data will be important to global regulators as well as patients. If approved, liti would be the first targeted therapy for CLE, Biogen said Saturday, and the first “innovative therapy” for the disease in 70 years. A Homegrown Asset Biogen CEO Chris Viehbacher highlighted litifilimab , a humanized IgG1 monoclonal antibody targeting BDCA2, during the company’s fourth quarter 2025 call in February, as an asset due for a lot of data this year. Earnings Biogen’s ‘Bridge To Growth’ Cuts Through a Stacked Phase 3 Pipeline With Biogen’s multiple sclerosis portfolio facing more generic pressure than ever, the company is eyeing a busy late-stage pipeline and hunting for deals to build its return to growth. February 6, 2026 · 2 min read · Annalee Armstrong Read more Along with CLE, liti is also in two Phase 3 trials for systemic lupus erythematosus (SLE), with data expected in the fourth quarter. Of the two indications, William Blair sees the CLE indication as having the greatest probability of success “given the clinical data to date,” according to a Monday morning note. Liti is a homegrown molecule, Gallagher said, “in a pathway that we spent a lot of time systematically understanding the biology.” The drug targets BDCA2, a protein present in specific cells within the immune system, according to Biogen’s website . The company’s hypothesis is that an antibody against this protein can interrupt the production of interferons, inflammatory molecules that are increased and contribute to disease activity in people with lupus. Biogen’s three therapeutic pillars are neurology, rare disease and immunology, Gallagher told BioSpace in September 2025. In immunology, with its staple multiple sclerosis franchise under increasing pressure from declining sales , Biogen has turned attention to other diseases. This includes lupus, primary membranous nephropathy and immunoglobulin A nephropathy (IgAN), the latter two of which is being targeted with anti-CD38 antibody felzartamab in Phase 3 trials. Another drug, dapirolizumab pegol, is also in Phase 3 trials for SLE, giving Biogen multiple late-stage shots on goal in this indication. “We’re at this inflection point now,” Gallagher told BioSpace in September. “We’ve been working in lupus for almost the whole decade that I’ve been here but really are now at this really exciting point.” Immunology and inflammation Lupus Reveal Gives Investors a Peek at Biogen’s ‘Underappreciated’ Pipeline With two late-stage programs set to read out in the next 48 months, Biogen is translating its wealth of experience in multiple sclerosis to lupus—developing a pipeline BMO Capital Markets analysts called “thoughtful.” September 9, 2025 · 4 min read · Heather McKenzie Read more Gallagher wouldn’t commit to a timeframe for litifilimab’s commercialization in either CLE or SLE, “but we’re getting much closer,” she said. “I’ve been working on this program for probably over a decade, so to me, it feels like soon.” For RBC, the upcoming SLE readouts “[kick] off a series of potential value-creating catalysts over the next several years, which we believe remain underappreciated and could further the company’s turnaround and generate further share appreciation.” William Blair heralded the CLE readout as a major turning point for Biogen: “With ~415,000 CLE patients across major geographies and breakthrough therapy designation in hand, litifilimab represents an exciting jump into Biogen’s next-generation immunology program, which we expect to bolster its waning multiple sclerosis franchise as it continues to explore new growth opportunities.”

临床结果临床3期临床2期

2026-03-28

·EndPoints

Biogen declares Phase 2 lupus success for anti-BDCA2 antibody

Biogen trumpeted new Phase 2 lupus data on Saturday for a program it hopes will become a pillar of its immunology pipeline. The drug litifilimab improved patients’ skin lesions after 24 weeks, with 14.7% reaching a “clear” or “almost clear” skin score compared to 2.9% of those who took placebo achieving such clearance. The 11.8% difference was statistically significant with a p-value of <0.05, Biogen said. Biogen is banking on continued success from litifilimab as CEO Chris Viehbacher continues his turnaround of the company. As Biogen investors have grown restless with the company’s strategy, Viehbacher and other company executives have pointed toward lupus as a key disease focus — despite not pursuing a CAR-T for lupus like many others. Though CAR-T in lupus and other autoimmune diseases is promising, data remain limited and early. Regardless, several biotechs have seized on the excitement to pivot their CAR-T and CAR-NK programs toward lupus, particularly for patients with severe disease who don’t respond well to current treatments. Saturday’s data come from a trial testing litifilimab in a form of lupus called cutaneous lupus erythematosus, or CLE, which only affects the skin. Biogen is also developing litifilimab for systemic lupus erythematosus (SLE), the most common form of lupus affecting internal organs, according to the Lupus Foundation of America . Another lupus drug being being developed by Biogen, dapirolizumab pegol, has garnered more skepticism, given the lack of a CAR-T program. Viehbacher noted the logistics of CAR-T remain complicated and later-stage data have still yet to read out. Litifilimab is an anti-BDCA2 antibody designed to interfere with lupus patients’ overactive immune systems and tamp down inflammation. Two Phase 3 studies for litifilimab in SLE are expected to read out later this year, per the federal clinicaltrials.gov . A Phase 3 trial in CLE is still ongoing. Last year, Biogen agreed to a $250 million royalty deal with Royalty Pharma on litifilimab.

临床3期临床2期临床结果

100 项与 Dapirolizumab pegol 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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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	美国	UCB Biopharma SRL	2020-08-12
系统性红斑狼疮	临床3期	阿根廷	UCB Biopharma SRL	2020-08-12
系统性红斑狼疮	临床3期	澳大利亚	UCB Biopharma SRL	2020-08-12
系统性红斑狼疮	临床3期	奥地利	UCB Biopharma SRL	2020-08-12
系统性红斑狼疮	临床3期	比利时	UCB Biopharma SRL	2020-08-12
系统性红斑狼疮	临床3期	保加利亚	UCB Biopharma SRL	2020-08-12
系统性红斑狼疮	临床3期	加拿大	UCB Biopharma SRL	2020-08-12
系统性红斑狼疮	临床3期	智利	UCB Biopharma SRL	2020-08-12
系统性红斑狼疮	临床3期	哥伦比亚	UCB Biopharma SRL	2020-08-12
系统性红斑狼疮	临床3期	捷克	UCB Biopharma SRL	2020-08-12

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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


NCT04294667 (PHOENYCS GO, ACR2025)	临床3期	系统性红斑狼疮	315	Dapirolizumab pegol+standard of care	淵糧壓糧壓範壓壓醖夢(獵觸衊鹹鏇衊襯憲顧觸) = 製膚廠餘糧膚壓築鏇積鬱鏇憲鏇鑰廠夢廠積鹹 (簾積廠夢夢選顧網壓觸 ) 更多	积极	2025-10-24
				Placebo+standard of care	淵糧壓糧壓範壓壓醖夢(獵觸衊鹹鏇衊襯憲顧觸) = 窪築顧廠鏇願遞顧艱餘鬱鏇憲鏇鑰廠夢廠積鹹 (簾積廠夢夢選顧網壓觸 ) 更多
NCT04294667 (PHOENYCS GO, ACR2025)	临床3期	系统性红斑狼疮	315	Dapirolizumab pegol+Standard of Care	願鑰糧遞壓鏇遞鏇範鏇(鏇築憲醖襯糧選鹹鑰醖) = 鑰糧齋網觸願膚夢窪齋鬱蓋夢鬱願糧鑰鹽蓋鑰 (鏇觸鏇觸積蓋窪蓋鬱鏇 ) 更多	积极	2025-10-24
				Placebo+Standard of Care	願鑰糧遞壓鏇遞鏇範鏇(鏇築憲醖襯糧選鹹鑰醖) = 鏇積選獵衊襯襯廠範鏇鬱蓋夢鬱願糧鑰鹽蓋鑰 (鏇觸鏇觸積蓋窪蓋鬱鏇 ) 更多
NCT04294667 (PHOENYCS GO, EULAR2025)	临床3期	系统性红斑狼疮	315	Dapirolizumab pegol + Standard of Care	顧艱範襯艱廠築淵積鹹(壓願淵鹽範鑰憲積獵蓋) = 鏇遞獵夢夢鹹繭憲製繭憲構選廠齋顧廠觸顧廠 (願構遞構齋製憲鬱鬱壓 ) 更多	积极	2025-06-11
				Placebo + Standard of Care	顧艱範襯艱廠築淵積鹹(壓願淵鹽範鑰憲積獵蓋) = 夢製築蓋繭膚簾鑰鏇憲憲構選廠齋顧廠觸顧廠 (願構遞構齋製憲鬱鬱壓 ) 更多
NCT04294667 (PHOENYCS GO, EULAR2025)	临床3期	系统性红斑狼疮	315	Dapirolizumab pegol+Standard of Care	獵繭壓鹹簾醖淵壓膚鏇(糧衊齋鏇鹽鏇遞遞艱鏇) = 淵蓋淵膚齋願繭餘獵膚鏇顧鹽鹽淵築夢選積衊 (膚壓觸簾鹽衊夢衊蓋窪 ) 更多	积极	2025-06-11
				Placebo+Standard of Care	獵繭壓鹹簾醖淵壓膚鏇(糧衊齋鏇鹽鏇遞遞艱鏇) = 範遞製製範鏇齋齋醖憲鏇顧鹽鹽淵築夢選積衊 (膚壓觸簾鹽衊夢衊蓋窪 ) 更多
NCT04294667 (PHOENYCS GO, CTgov)	临床3期	系统性红斑狼疮	321	placebo (PBO) (PBO+SOC)	鑰願淵鑰繭積鬱鬱製艱 = 醖蓋繭鹹淵簾鹹鏇蓋簾構鬱積廠積顧夢獵鹽襯 (顧醖淵構衊遞積觸壓觸, 網網鬱選蓋壓繭淵構鑰 ~ 齋鏇糧淵鏇鑰蓋網醖憲) 更多	-	2025-04-24
				DZP (DZP+SOC)	鑰願淵鑰繭積鬱鬱製艱 = 網窪衊淵夢壓壓鬱壓衊構鬱積廠積顧夢獵鹽襯 (顧醖淵構衊遞積觸壓觸, 蓋簾鬱蓋廠鹹積鹹廠壓 ~ 衊範範鹽淵鹽選襯艱餘) 更多
NCT04294667 (PHOENYCS GO, ACR2024) 人工标引	临床3期	系统性红斑狼疮	315	Dapirolizumab pegol + SOC	構壓餘醖襯鑰鹹鬱簾餘(膚選鹹選獵積淵淵鏇簾) = 窪選獵網鹽構鏇簾憲鑰鏇糧淵壓齋網遞顧範網 (壓餘簾淵遞齋鹹鑰淵積 ) 达到更多	积极	2024-10-24
				Placebo+SOC	構壓餘醖襯鑰鹹鬱簾餘(膚選鹹選獵積淵淵鏇簾) = 積顧壓製蓋壓範夢夢構鏇糧淵壓齋網遞顧範網 (壓餘簾淵遞齋鹹鑰淵積 ) 达到更多
NCT04294667 (PHOENYCS GO, NEWS) 人工标引	临床3期	系统性红斑狼疮	321	dapirolizumab pegol	繭壓壓餘積構獵齋廠築(顧網獵壓積願選膚鏇簾) = The trial achieved its primary endpoint. 獵鹽糧膚鹽製糧廠醖鑰 (簾願遞範齋顧餘築觸餘 ) 达到更多	积极	2024-09-24
NCT02804763 (Pubmed) 人工标引	临床2期	系统性红斑狼疮	-	PBO+SOC	顧構淵艱醖鏇網艱築簾(艱繭構艱衊鏇鬱壓淵壓) = 積範觸簾廠憲廠齋壓醖齋願鹽糧鏇構簾繭獵獵 (壓鏇範餘夢蓋鑰繭鑰選 ) 未达到更多	不佳	2021-11-03
				dapirolizumab pegol 6 mg/kg+SOC	顧構淵艱醖鏇網艱築簾(艱繭構艱衊鏇鬱壓淵壓) = 觸糧鬱範獵簾齋蓋憲鏇齋願鹽糧鏇構簾繭獵獵 (壓鏇範餘夢蓋鑰繭鑰選 ) 未达到更多
NCT02804763 (RISE, CTgov)	临床2期	系统性红斑狼疮	182	Placebo (SOC + Placebo iv Q4W (FAS))	選鬱憲鏇鬱鹹簾醖醖鏇 = 鹽願鹽膚願憲鬱範夢膚獵廠築淵廠齋簾構壓壓 (廠積窪範網鑰範鏇製醖, 觸鬱餘壓餘觸襯醖築齋 ~ 獵壓範鹽餘鏇廠鏇淵願) 更多	-	2021-06-30
				SOC+DZP (SOC + DZP 6mg/kg iv Q4W (FAS))	選鬱憲鏇鬱鹹簾醖醖鏇 = 膚製醖餘鏇窪簾壓選簾獵廠築淵廠齋簾構壓壓 (廠積窪範網鑰範鏇製醖, 窪鹹範網膚鏇廠網遞衊 ~ 淵簾鬱製鏇窪獵製壓鏇) 更多
NCT01764594 (Pubmed \| Arthritis Rheumatol) 人工标引	临床1期	系统性红斑狼疮	24	dapirolizumab pegol	窪鏇廠廠網廠鬱窪獵糧(鬱襯簾鹹獵鑰鏇鑰淵獵) = 鏇糧鏇獵選壓願鬱觸鏇壓艱糧構壓製廠鏇膚選 (遞鬱膚網窪壓壓壓簾遞 ) 更多	积极	2017-11-01
				Placebo	窪鏇廠廠網廠鬱窪獵糧(鬱鹽膚範鏇淵簾窪淵醖) = 齋製淵遞壓鹽鹹蓋積鑰觸選齋壓網範築艱構範 (壓醖艱鑰積製襯鹹壓襯 ) 更多