A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy.
The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with systemic lupus erythematosus (SLE); to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.

开始日期2023-10-03

申办/合作机构

Biogen, Inc.

100 项与 Litifilimab 相关的临床结果

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100 项与 Litifilimab 相关的转化医学

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100 项与 Litifilimab 相关的专利（医药）

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项与 Litifilimab 相关的文献（医药）

2024-05-01·Current opinion in rheumatology

Emerging biologic therapies for systemic lupus erythematosus

Review

作者: Kato, Hiroshi ; Kahlenberg, J. Michelle

Purpose of review:

The approval of belimumab and anifrolumab has expanded the scope of treatment for systemic lupus erythematosus (SLE) patients. However, many patients remain refractory to currently available therapies and suffer from drug toxicities. This review will discuss approved and target-specific therapeutics in development that bring hope for better SLE treatments.

Recent findings:

Since the last review on this subject in the journal, the FDA has approved anifrolumab and belimumab for SLE and lupus nephritis (LN), respectively. A fully humanized anti-CD20, obinutuzumab, met the primary end point in a phase II trial in LN. A Tyk2 inhibitor, deucravacitinib, and an antibody targeting plasmacytoid dendritic cells, litifilimab, met the primary end point in phase II trials in SLE and cutaneous lupus erythematosus (CLE). Ustekinumab and baricitinib met the primary end point in phase II but not in phase III trials.

Summary:

While many drug candidates which met the end points in phase II trials have failed phase III trials, the number of target-specific therapies for SLE has continued to expand.

2024-01-01·Immunotherapy

The Development of Litifilimab (BIIB 059) for Cutaneous and Systemic Lupus Erythematosus

Review

作者: Furie, Richard ; Cho, Young Min

This review describes the litifilimab (BIIB 059) development program to date for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). Plasmacytoid dendritic cells (pDCs), major producers of type I interferons (IFN-I), play a key role in SLE pathogenesis. Litifilimab, a humanized monoclonal antibody, binds to BDCA2, a protein uniquely expressed on pDCs. The consequence of BDCA2 ligation is the inhibition of IFN-I as well as IFN-III, cytokine and chemokine production. Phase I and II LILAC trial parts A and B achieved primary end points in SLE and CLE patients, confirming the importance of pDCs and IFN-I in SLE and CLE. Litifilimab is currently being evaluated in phase III trials in both SLE and CLE.

2023-07-01·American journal of clinical dermatology

Cutaneous Lupus Erythematosus: An Update on Pathogenesis and Future Therapeutic Directions.

Review

作者: Brägelmann, Christine ; Niebel, Dennis ; de Vos, Luka ; Fetter, Tanja ; Wenzel, Jörg

Lupus erythematosus comprises a spectrum of autoimmune diseases that may affect various organs (systemic lupus erythematosus [SLE]) or the skin only (cutaneous lupus erythematosus [CLE]). Typical combinations of clinical, histological and serological findings define clinical subtypes of CLE, yet there is high interindividual variation. Skin lesions arise in the course of triggers such as ultraviolet (UV) light exposure, smoking or drugs; keratinocytes, cytotoxic T cells and plasmacytoid dendritic cells (pDCs) establish a self-perpetuating interplay between the innate and adaptive immune system that is pivotal for the pathogenesis of CLE. Therefore, treatment relies on avoidance of triggers and UV protection, topical therapies (glucocorticosteroids, calcineurin inhibitors) and rather unspecific immunosuppressive or immunomodulatory drugs. Yet, the advent of licensed targeted therapies for SLE might also open new perspectives in the management of CLE. The heterogeneity of CLE might be attributable to individual variables and we speculate that the prevailing inflammatory signature defined by either T cells, B cells, pDCs, a strong lesional type I interferon (IFN) response, or combinations of the above might be suitable to predict therapeutic response to targeted treatment. Therefore, pretherapeutic histological assessment of the inflammatory infiltrate could stratify patients with refractory CLE for T-cell-directed therapies (e.g. dapirolizumab pegol), B-cell-directed therapies (e.g. belimumab), pDC-directed therapies (e.g. litifilimab) or IFN-directed therapies (e.g. anifrolumab). Moreover, Janus kinase (JAK) and spleen tyrosine kinase (SYK) inhibitors might broaden the therapeutic armamentarium in the near future. A close interdisciplinary exchange with rheumatologists and nephrologists is mandatory for optimal treatment of lupus patients to define the best therapeutic strategy.

项与 Litifilimab 相关的新闻（医药）

2024-09-17

·FiercePharma

Lupus landscape 'poised for evolution' as US doctors eagerly await new entrants

Biogen's litifilimab "stands out as an especially strong competitor" to Benlysta and Saphnelo, according to Spherix Global Insights analysts. New biologics such as GSK's Benlysta and AstraZeneca's Saphnelo, along with off-label drugs, have been the mainstay for systemic lupus erythematosus (SLE) treatment for many years. However, the landscape may be about to change with the introduction of new medicines and indications from other approved treatments.That's according to Spherix Global Insights analysts who spoke to 101 U.S. rheumatologists about current and future treatments for SLE, a landscape they see as “poised for evolution.”There are several types of lupus, with SLE the most common. The condition is caused by an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage. Organ damage can occur in up to 48% of people living with lupus, most within five years of diagnosis, with lupus flares also upping the risk of organ damage.GSK’s SLE drug Benlysta, which was approved by the FDA in 2011, has now become a blockbuster medicine, while AstraZeneca’s new challenger Saphnelo, FDA-approved in 2021, remains some way behind the market leader in Benlysta in terms of sales.Doctors have also relied on off-label use of other older medicines, including rituximab. However, Spherix found in a 2023 report, this use has begun to lose favor among rheumatologists as they turn to newer biologics.Now, Spherix has found that an experimental drug from Biogen, litifilimab, “stands out as an especially strong competitor” to Benlysta and Saphnelo, according to its report. Talking to rheumatologists, Spherix analysts said that they believe litifilimab’s latest midstage data, notably its 26% improvement in SRI-4 response (a measurement on how well a patient responds to treatment) over placebo, “demonstrates a superior treatment profile compared to existing biologics and other promising therapies.”There is also hope from new indications from already-approved drugs in the form of AbbVie’s blockbuster immunology drug Rinvoq, which is in phase 3 testing for SLE, and Bristol Myers Squibb’s Sotyktu, which presented positive data in SLE at the start of the year.Spherix found that these oral therapies “offer convenience for patients and may appeal to rheumatologists seeking alternative treatment options.”Getting patients to stay on them, however, can be a “challenge,” while black box warnings on JAKs (i.e., Rinvoq) “may prevent use in earlier lines of SLE treatment,” according to Spherix. Despite that, rheumatologists “are most eager to see Rinvoq approved for SLE, followed by Sotyktu and litifilimab, all of which are believed to be potentially effective for skin manifestations,” the report found.There are also other investigational contenders in the form of UCB Pharma’s dapirolizumab pegol and Idorsia’s cenerimod.All new entrants must, however, be mindful of the “dominance” of Benlysta, the analysts conclude, which “remains a preferred choice” in both SLE and lupus nephritis.

临床结果上市批准临床3期

2024-09-10

·同写意

聊聊千亿自免领域蓝海：系统性红斑狼疮SLE

自身免疫疾病领域是全球仅次于肿瘤的第二大用药市场，具有庞大的市场规模和增长潜力。从2023 年的全球药物销售情况来看，自免领域多款重磅炸弹均保持快速成长的趋势。虽然Humira因仿制药上市在2022年退下了久居十年的“药王”宝座，但Dupixent首次突破百亿美元，预计COPD获批后还会进一步推高其销售额。 IL-12、IL-23、CD20、IL-17、JAK等靶点药物销售额也迅速增长，同时随着这些重磅药物的出现，Asthma、AD、IBD、RA、Psoriasis等多个自免疾病的热度进一步推高，各大药企也争相布局相关管线。特别是2022年来，自免领域的交易和收购一波接一波，MNC纷纷入场，交易金额屡创新高。 2023年全球药品销售额TOP50中自免领域药物 1 未被满足的需求蓝海系统性红斑狼疮（Systemic Lupus Erythematosus, SLE）是一种系统性自身免疫病，以全身多系统多脏器受累、反复的复发与缓解、体内存在大量自身抗体为主要临床特点，如不及时治疗，会造成受累脏器的不可逆损害，最终导致患者死亡。 SLE的临床表现具有高度异质性，系统受累表现多样，病程和疾病严重程度不一；不同患者临床表现各异，同一患者在病程不同阶段出现不同的临床表现；相同临床表型的患者预后亦有差异。SLE的自然病程多为病情的加重与缓解交替。 SLE临床表现系统性红斑狼疮---皮疹全球SLE患者数量约800万人。根据《2020中国系统性红斑狼疮诊疗指南》，我国约有100万名SLE患者。SLE患病率地域差异较大，全球患病率为0~241/10万，中国大陆地区患病率约为30~70/10万；发病率全球为5.14/10万人；中国为8.57/10万人，并且SLE好发于育龄期女性，女性发病年龄多为15~40岁，男女患病比约为1:10。指南疗法方面，羟氯喹和糖皮质激素作为无禁忌SLE患者的长期基础治疗，疗效不佳时可联合使用免疫抑制剂，并适当调整激素用量；经激素和/或免疫抑制剂治疗效果不佳、不耐受或复发的SLE患者，可考虑使用生物制剂进行治疗。 2019年EULAR SLE治疗建议总结系统性红斑狼疮SLE用药原则--《2020中国系统性红斑狼疮诊疗指南》 2 机制与创新药物靶点 SLE的发病机制较复杂，涉及先天免疫和适应性免疫反应的失调，多种细胞和体液成分在其中发挥关键作用，B细胞免疫异常与I型干扰素（IFN）系统的激活已被验证是SLE的核心发病机制，目前药物开发的主流方向也是基于此。除此之外，以下这些元素共同参与了SLE的复杂免疫途径，突显了SLE发病机制的多面性：（1）中性粒细胞（Neutrophils）及其产物（如中性粒细胞外陷阱）是强大的核酸来源，这些核酸可以激活浆细胞样树突状细胞，并通过降低其激活阈值来刺激T细胞；（2）巨噬细胞（Macrophages）在狼疮的发病和传播中都有重要作用。巨噬细胞清除凋亡细胞的能力缺陷可能导致凋亡物质的积累，从而成为自身抗原的来源。巨噬细胞是促炎细胞因子（如IL-1、IL-6和IFNγ）的关键生产者，作为抗原呈递细胞，并释放炎症介质，引起组织损伤和纤维化；（3）自然杀伤细胞（Natural killer cells）在调节其他免疫细胞的活性和生存方面发挥重要作用，并产生细胞因子（如IFNγ和IL-17）；（4）自身反应性CD4 T细胞和B细胞会增强免疫反应，它们的激活依赖于共刺激分子的适当结合；（5）浆细胞（Plasma cells）的成熟过程依赖于在细胞因子（如B细胞激活因子）的影响下，B细胞的增殖和分化。（6）Th17细胞是产生IL-17或IL-21等细胞因子的CD4 T辅助细胞的一个亚群，能够促进炎症和浆细胞的分化。Th17细胞在IL-23的影响下被激活、扩增和维持。（7）CD8+细胞毒性T细胞能够在皮肤、肾脏或大脑中介导组织损伤。（8）调节性T细胞（Regulatory T cells）是CD4 T细胞的一个亚群，对于维持免疫耐受性和防止自身免疫反应至关重要。 SLE发病的关键细胞和体液驱动因素作为SLE标准治疗的药物，羟氯喹、糖皮质激素等自1950年代以来就已开始使用。1960年代，医生开始联用免疫抑制剂应对SLE。 2011年贝利木单抗（Belimumab）FDA获批，成为50年来首个获批治疗SLE的生物制剂；2019年该药在我国获批，随后适应证扩大至儿童SLE和成人狼疮肾炎（LN）。 2021年FDA批准了2款新药，一款是靶向Ⅰ型干扰素受体（IFNAR）单抗药物Anifrolumab，另一个是小分子钙调磷酸酶抑制剂Voclosporin获批用于LN。泰它西普2021年基于II期数据在我国附条件获批上市，2023年11月转为完全批准。利妥昔单抗（Rituximab）最早获批用于治疗淋巴瘤，其针对SLE和LN 治疗的两项临床试验未达主要终点，因此没有获得SLE适应证，然而临床实践中观察到其有效性，目前在某些临床表型的SLE患者中仍使用。 SLE治疗药物发展Timeline及未来展望现有治疗SLE的生物制剂概览由于目前获批SLE适应症的药物较少，市场目前还是一片蓝海，从数据库查询，2022年欧美日国家市场规模达到26亿美元，预计十年后将翻倍。弗若斯特沙利文数据则显示，2020年全球SLE治疗药物市场规模达16亿美元，预计2025年将达65亿美元。2021年中国SLE药物市场规模约4亿美元，预计2030年市场规模将达到34亿美元。 SLE在研药物靶点，主要包括以下几个方向，部分靶点药物已获批用于治疗SLE外的其他疾病，这些新靶点也为SLE疾病的治疗带来了新的可能性： • 靶向B细胞：CD19、CD22、CD20、CD38、BAFF-APRIL等； • 靶向T细胞共刺激因子：CD40-CD40L和CD28–CD80/CD86等； • 靶向DC细胞：TLR、BDCA2等； • 靶向胞内信号转导途径：JAK1/JAK2、BTK等； • 靶向细胞因子：IL12-IL23、IL17、IFN等。 SLE已批准和在研药物靶点 3 本土创新的崛起荣昌生物在SLE领域已有获批产品泰它西普，并且近年来一直在做临床试验尝试拓展其他适应症。此外，国内主要进军这一领域的药企，包括布局生物药的恒瑞医药、康诺亚、智翔金泰、科越医药等；布局小分子化药的诺诚健华、亚盛医药、安锐生物等；还有布局细胞疗法的明聚生物、亘喜生物、博雅辑因等企业，但项目均还在临床早期，未有临床结果公布。 5月，中国学者在EULAR2024上发布了一款CD19靶向的CAR-T细胞疗法在中国成年人活动性SLE患者中的最新临床数据，表现出了良好的安全性和有效性。据了解，近几年CD19靶向的CAR-T细胞疗法已有多篇文献报道其在SLE患者中的临床获益，该疗法可能成为SLE有效的治疗手段，尤其是给难治性SLE患者带来新的治疗选择。 8月，三生国健披露该公司申报了SLE领域相关新药项目BDCA2抗体，为国内首家申报临床，同时也是该靶点全球第二款获FDA批准进入临床的抗体药物，有BIC潜力。据调研，该靶点较新颖，全球首款BDCA2抗体为渤健的BIIB059，用于治疗SLE和CLE，目前处于临床III期阶段。很高兴看到国内企业能够在临床开发难度极高的SLE领域对新靶点进行布局跟进，这也体现了现阶段国内药企开始从跟风热门靶点到敢于冒险创新的转变。目前，自免领域特应性皮炎、银屑病等疾病热门靶点赛道已开始拥挤，并且即将迎来国产化替代。但由于国内自免市场仍有巨大的未被满足临床需求，而且随着医疗水平、诊疗率的进一步提升，未来市场还有很大的提升空间，所以也吸引着越来越多国内药企布局自免管线。各企业对于自免创新药的布局与立项也在逐步前移，与国际化接轨，希望能够加快我国自免创新药的开发与临床应用，给国内数千万自免患者带来新的希望。参考文献(上下滑动查看更多)： 1.Siegel CH, Sammaritano LR. Systemic Lupus Erythematosus: A Review. JAMA. 2024 May 7;331(17):1480-1491. doi: 10.1001/jama.2024.2315 2.《2020中国系统性红斑狼疮诊疗指南》 3.Fanouriakis A, Kostopoulou M, Alunno A, et al. 2019. 2019 Update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann. Rheum. Dis. 78:736–45 4.Deligeorgakis D, Skouvaklidou E, Adamichou C. Interferon Inhibition in SLE: From Bench to Bedside. Mediterr J Rheumatol. 2024 Jun 30;35(Suppl 2):354-364. doi: 10.31138/mjr.010324.iis 5.Venturelli V, Isenberg DA. Targeted Therapy for SLE-What Works, What Doesn't, What's Next. J Clin Med. 2023 Apr 29;12(9):3198. doi: 10.3390/jcm12093198 6.Athanassiou P, Athanassiou L. Current Treatment Approach, Emerging Therapies and New Horizons in Systemic Lupus Erythematosus. Life (Basel). 2023 Jul 1;13(7):1496. doi: 10.3390/life13071496 7.Rönnblom L, Pascual V. The innate immune system in SLE: type I interferons and dendritic cells. Lupus. 2008 May;17(5):394-9. doi: 10.1177/0961203308090020 8.Murphy G, Isenberg DA. New therapies for systemic lupus erythematosus - past imperfect, future tense. Nat Rev Rheumatol. 2019 Jul;15(7):403-412. doi: 10.1038/s41584-019-0235-5 9.Hoi A, Igel T, Mok CC, Arnaud L. Systemic lupus erythematosus. Lancet. 2024 May 25;403(10441):2326-2338. doi: 10.1016/S0140-6736(24)00398-2 10.Morand EF, Fernandez-Ruiz R, Blazer A, Niewold TB. Advances in the management of systemic lupus erythematosus. BMJ. 2023 Oct 26;383:e073980. doi: 10.1136/bmj-2022-073980 11.Lazar S, Kahlenberg JM. Systemic Lupus Erythematosus: New Diagnostic and Therapeutic Approaches. Annu Rev Med. 2023 Jan 27;74:339-352. doi: 10.1146/annurev-med-043021-032611 同写意媒体矩阵，欢迎关注↓↓↓

并购临床研究临床结果

2024-09-09

·CPHI制药在线

BDCA2：红斑狼疮潜力新靶点，BIIB059已进入3期临床

关注并星标CPHI制药在线 BDCA2，全称血液树突状细胞抗原2，也称CLEC4C或CD303，属于钙依赖性凝集素家族，是一类含有213个氨基酸的新的二型跨膜糖蛋白，由胞外Ca2+依赖性碳水化合物识别结构域CRD、跨膜区及较短的胞内区构成，其中CRD可结合半乳糖末端残基等多种糖基，胞内区可与FcεRIγ结合。关于BDCA2 BDCA2主要在浆细胞样树突状细胞（pDC）上表达，而pDC是树突状细胞（DC）的一种亚类，通过大量分泌I型干扰素（IFN-I）来激活适应性免疫反应，并在机体抗病毒免疫中起关键作用。在免疫应答中，pDC通过TLR7和TLR9来识别病原体相关分子，并产生丰富的干扰素α（IFN-α）。IFN-α是一种强有力的抗病毒干扰素，可以抑制病毒的复制和传播，并激活其他免疫细胞参与免疫反应。 BDCA2是最新鉴定的pDC表面标记物之一，其胞外部分含有的C型碳水化合物识别域可与甘露糖、葡萄糖或N-乙酰葡糖胺结合，其胞内部分能通过FcR γ链在B细胞抗原受体样信号体中发出信号。BDCA2激活会引发酪氨酸激酶（Syk）的活化、B细胞连接蛋白（SLP65）的聚集和磷脂酰肌醇特异性磷酯酶（PLCγ2）的活性。而PLCγ2的激活可能导致Ca2+流入并在浆细胞样树突状细胞pDC中起到负调节剂的作用。通过BDCA2的信号传导途径减少NFKB（核因子κB）的活化，从而抑制IFN-I的产生。由此可以看出，BDCA2在pDC中可通过抑制干扰素产生，影响免疫应答，进而调控免疫系统。由于pDC产生IFNα/β被认为是SLE的主要病理生理因素。BDCA2被认为是阻断SLE产生干扰素α/β的潜力靶点。除了与SLE发病有关，BDCA2还在其他多种疾病中发挥作用，如慢性炎症、感染性疾病、肿瘤。研究发现BDCA2可与丙型肝炎病毒（HCV）颗粒或感染细胞表面的分子结构相互作用，能够识别病原体并启动免疫反应。而且，BDCA2还可以识别其他病毒，如 HIV、流感病毒和登革热病毒等。一旦与病原体结合，BDCA2能够激活pDC，促使其产生大量的IFN-I，从而抑制病毒的复制和传播。此外，研究发现CD4+CD56+血液皮肤肿瘤中的BDCA2表达与肿瘤的特征和生存时间相关。 BDCA2靶向药进展据不完全统计，目前全球药企已研发出几款在研BDCA2靶向药，如BIIB059（Litifilimab）、DB-2304。其中BIIB059是渤健开发的一款靶向BDCA2的全人源化IgG1单克隆抗体，通过抑制BDCA2减少包括IFN-I在内的炎性细胞因子的产生，起到调节狼疮病理机制的重要作用。 2020年11月，渤健宣布BIIB059治疗系统性红斑狼疮（SLE）的2期临床试验取得积极结果：使用疾病活跃关节总数（疼痛和肿胀的关节总数）评分，接受BIIB059皮下注射治疗的患者在第24周时总关节计数显著减少（p=0.037），达到试验的主要终点。此外，BIIB059治疗皮肤型红斑狼疮（CLE）的2期临床试验也已取得积极结果：BIIB059可改善CLE患者的皮肤病活动性，对CLE的治疗效果高于安慰剂治疗。具体数据为：从基线到第16周，衡量皮肤病活动指标的CLASI-A评分的最小二乘平均值（±SE）百分比变化：50mg litifilimab组为-38.8±7.5；150mg litifilimab组为-47.9±7.4；450mg litifilimab组为-42.5±5.5；安慰剂组为-14.5±6.4。 BIIB059是目前进展最快的一款BDCA2靶向药，其治疗CLE和SLE的临床试验均已进入3期阶段。 DB-2304是映恩生物研发的一款BDCA2靶向ADC。已公布的概念验证结果显示：DB-2304能够靶点依赖的递送小分子免疫抑制剂。相较抗BCDA2单抗，DB-2304具有更强的抑制pDC以及外周血细胞IFN-I分泌的能力。除抑制IFN-I分泌外，DB-2304还更能高效广谱地抑制其它炎症因子的分泌，并负调控SLE疾病严重性相关的干扰素效应基因组。此外，三生国健也开发一款BDCA2抗体。今年8月，该药在国内申报临床，成为首款申请临床试验的国产BDCA2抗体。总结目前，BDCA2靶点进展较慢，在研药物也较少，且主要被开发用于治疗红斑狼疮。其中渤健的BIIB059的进展最快，目前已进入3期临床。此外，除了治疗红斑狼疮，BDCA2靶向药还有望用于治疗多种疾病，如肿瘤、病毒感染。 END 【智药研习社直播预告】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~

多肽偶联药物临床失败临床结果临床3期

100 项与 Litifilimab 相关的药物交易

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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
皮肤红斑狼疮	临床3期	美国	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	阿根廷	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	保加利亚	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	智利	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	法国	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	匈牙利	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	意大利	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	斯洛伐克	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	西班牙	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	瑞典	Biogen, Inc.	2023-10-03

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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


NCT02847598 (LILAC \| LILAC study, CTgov)	临床2期	皮肤红斑狼疮 \| 系统性红斑狼疮	264	Placebo (Part A: Placebo)	鑰壓範顧網鬱鏇製遞夢(蓋製願鏇廠壓簾選築顧) = 壓繭鑰獵餘窪憲鹽齋繭築簾範鑰衊願夢獵蓋鑰 (範積蓋醖淵製蓋築廠選, 夢夢壓簾獵餘壓構糧齋 ~ 衊顧顧齋膚願範鹹觸齋) 更多	-	2023-05-15
				BIIB059 (litifilimab) (Part A: BIIB059 450 mg)	鑰壓範顧網鬱鏇製遞夢(蓋製願鏇廠壓簾選築顧) = 淵艱衊繭艱壓壓顧餘構築簾範鑰衊願夢獵蓋鑰 (範積蓋醖淵製蓋築廠選, 醖遞壓憲繭膚積鏇願範 ~ 願構蓋壓窪壓壓願鹹鏇) 更多
NCT02847598 (LILAC, Pubmed \| Br Dent J)	临床2期	系统性红斑狼疮	132	Litifilimab 450 mg	願願壓壓壓餘淵醖築鏇(鬱壓選齋選鬱網願鏇築): P-Value = 0.04 更多	积极	2022-09-08
				Placebo
NCT02847598 (LILAC, Pubmed \| Br Dent J)	临床2期	皮肤红斑狼疮	132	Litifilimab 50 mg	壓網選齋鏇選範築蓋淵(繭蓋製衊窪鬱糧夢鬱繭) = Litifilimab was associated with one case of herpes zoster infection 廠鹽鹽遞願遞膚廠簾鹽 (蓋築鑰壓願夢窪廠製廠 ) 更多	积极	2022-07-28
				Litifilimab 150 mg
NCT02847598 (LILAC study, EULAR2022)	临床2期	皮肤红斑狼疮 BDCA2	-	BIIB059	鹽衊鏇鬱顧獵鬱齋獵艱(顧遞鹽壓餘夢糧遞簾糧) = 積遞鏇糧繭窪廠鬱繭夢鑰艱範簾窪遞襯糧糧夢 (壓顧夢襯觸醖憲艱壓窪 ) 更多	积极	2022-06-01
NCT02847598 (LILAC, EULAR2022)	临床2期	系统性红斑狼疮 anti-nuclear antibodies \| anti-double-stranded DNA antibodies	-	BIIB059 450 mg	齋糧壓製積壓願鬱製憲(夢廠遞廠廠積夢築壓範) = 鑰遞衊齋窪餘醖廠範鏇餘網憲壓廠淵憲醖鏇醖 (積糧蓋醖繭廠蓋範衊顧 ) 更多	积极	2022-06-01
				Placebo	齋糧壓製積壓願鬱製憲(夢廠遞廠廠積夢築壓範) = 簾醖窪簾選鑰鬱窪願糧餘網憲壓廠淵憲醖鏇醖 (積糧蓋醖繭廠蓋範衊顧 ) 更多
NCT02847598 (LILAC, ACR2020) 人工标引	临床2期	系统性红斑狼疮	120	BIIB059	壓遞鬱繭鹹製糧鑰膚糧(膚繭簾鹽觸醖網觸簾襯) = 齋醖繭憲窪糧醖糧蓋願糧鏇鏇淵繭鹽壓鹹範網 (夢窪繭築繭簾製鹽鏇鑰, 1.2) 更多	积极	2020-11-07
				Placebo	壓遞鬱繭鹹製糧鑰膚糧(膚繭簾鹽觸醖網觸簾襯) = 構淵夢壓艱製膚願襯獵糧鏇鏇淵繭鹽壓鹹範網 (夢窪繭築繭簾製鹽鏇鑰, 1.3) 更多
NCT02847598 (LILAC, ACR2020)	临床2期	系统性红斑狼疮 ANA \| anti-dsDNA antibodies	-	BIIB059 450 mg	醖觸築積糧願鏇繭鬱選(製範選願艱艱顧製齋糧) = 願鹹醖糧顧鹽遞齋襯獵鑰選艱淵鹹膚範顧淵範 (餘築鑰憲鹹襯糧築製範, 1.2)	积极	2020-11-07
				Placebo	醖觸築積糧願鏇繭鬱選(製範選願艱艱顧製齋糧) = 製遞壓鬱餘衊築淵鹹鹹鑰選艱淵鹹膚範顧淵範 (餘築鑰憲鹹襯糧築製範, 1.3)
LILAC (EULAR2020)	临床2期	皮肤红斑狼疮	132	BIIB059 50 mg	積築憲鹹網獵願鑰餘淵(襯範繭觸製窪鏇製鹹鑰) = 62 (62.6%) 80 (60.6%) 遞鹽淵範築觸艱製鹽選 (積蓋簾襯衊廠觸餘製壓 ) 更多	积极	2020-06-03
				BIIB059 150 mg
NCT02847598 (Pubmed)	临床2期	系统性红斑狼疮	264	BIIB059	淵製製選艱廠遞壓餘製(艱壓餘鹽齋齋獵鑰憲構) = 構製觸鏇簾夢淵艱鬱淵膚淵齋簾餘鹽獵繭糧積 (艱醖廠築範醖鏇積窪憲 ) 更多	-	2020-06-01
NCT02106897 (Pubmed \| J Clin Invest) 人工标引	临床1期	湿疹 \| 系统性红斑狼疮	54	BIIB059	觸獵遞範夢壓顧淵築獵(壓艱遞膚餘艱獵廠繭艱) = 製範鏇壓衊糧築憲糧淵蓋鏇築鏇醖製獵選獵壓 (鹽遞窪憲窪襯憲膚糧製 ) 更多	积极	2019-03-01
				Placebo	觸獵遞範夢壓顧淵築獵(壓艱遞膚餘艱獵廠繭艱) = 構網製餘鏇蓋築蓋構顧蓋鏇築鏇醖製獵選獵壓 (鹽遞窪憲窪襯憲膚糧製 ) 更多