A Randomized, Open-Label, 2-Arm, 2-Part, Parallel Group Study to Assess the Pharmacokinetic Comparability of Subcutaneously Administered Litifilimab (BIIB059) Delivered by 3 Devices (Pre-Filled Syringe, Autoinjector, or On-Body Injector) in Healthy Participants

In this study, researchers will learn how the body processes litifilimab when it is given under the skin in 3 different ways. Currently, ongoing studies utilize pre-filled syringes (PFS) that can deliver litifilimab subcutaneously (SC), also known as under the skin.
In this study, researchers want to learn more about new ways of delivering litifilimab SC using either an autoinjector (AI) or an on-body injector (OBI):
Both devices are designed to deliver litifilimab in an automatic way, especially helping patients who may not be able to use their hands very well, or who may be afraid of needles. While the AI is handheld, the OBI device works by being placed on the skin and can help deliver the highest amount of litifilimab through a single injection. The main objective of this study is to learn how the body processes litifilimab after using the AI device or the OBI device, as compared to using the PFS method.
The main questions researchers want to answer are:
* What is the highest amount of litifilimab found in the blood after dosing? How much total litifilimab is found in the blood throughout the study? Researchers will also learn more about: Any medical problems the participants have during the study
* Any injection site pain or reactions the participants may have. Any skin reactions to the OBI device
* Any changes in the participants' overall health after receiving litifilimab.
This study will be done as follows:
* Participants will be screened to check if they can join the study. The screening period will be up to 4 weeks, after which selected participants will check into their study research center.
* Participants will be randomly assigned to be in Part 1 or Part 2 of the study:
* Part 1: Participants will receive SC injection(s) of litifilimab through either the AI device or through PFS.
* Part 2: Participants will receive SC injection(s) of litifilimab through the OBI device or through PFS.
* Participants will remain at their study research center for the first 8 days. After that, there will be a follow-up period for 17 weeks during which participants return to the center a total of 6 times.
Each participant will be in the study for about 22 weeks.

开始日期2025-01-02

申办/合作机构

Biogen, Inc.

NCT06044337

/ Enrolling by invitation临床3期

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

In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.
The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301.
The main objective of the study is to learn more about the long-term safety of litifilimab.
The main question researchers want to answer is:
- How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are unwanted health problems that may or may not be caused by the study drug.
Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).
Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab.
The study will be done as follows:
* The last visit of parent study 230LE301 will be the first visit of study 230LE305.
* All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug.
* Globally, the treatment period will last up to 104 weeks, or 2 years. For participants in the United States, the treatment period may last up to 260 weeks, or 5 years
* There will be a follow-up safety period that lasts up to 24 weeks.
* Globally, participants will have up to 27 study visits during the treatment period. In the US, participants will have up to 66 study visits.
* Globally, the total study duration for participants will be up to 128 weeks. In the US, the total study duration will be up to 284 weeks .

开始日期2023-10-03

申办/合作机构

Biogen, Inc.

NCT05531565

/ Recruiting临床2/3期

A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in 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 (AMETHYST)

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.
The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms and signs of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).
The main questions researchers want to answer are:
* How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment?
* How many participants have their skin disease activity go down by at least 70% as measured by CLASI?
Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires.
The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows:
* After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine.
* Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks.
* The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
* This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin.
* During the 2nd treatment period, all participants will receive litifilimab for 28 weeks.
* After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks.
* The total study duration for participants will be up to 80 weeks.

开始日期2022-09-13

申办/合作机构

Biogen, Inc.

100 项与利替非利单抗相关的临床结果

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100 项与利替非利单抗相关的专利（医药）

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项与利替非利单抗相关的文献（医药）

2026-01-01·The Journal of clinical and aesthetic dermatology

What's New in Cutaneous Lupus Erythematosus: Guidelines, Biologics, and Beyond.

Review

作者: Childs, Beth A ; Merola, Joseph F

OBJECTIVE:

We aim to review current treatment strategies for cutaneous lupus erythematosus (CLE) and highlight emerging therapies, evolving outcome measures, and practical considerations that may inform future management of this clinically heterogeneous disease.

METHODS:

We conducted a narrative review of the literature using PubMed to identify relevant clinical trials, observational studies, and mechanistic investigations related to CLE treatment. Emphasis was placed on studies published within the past 15 years. Expert opinion from dermatology and rheumatology was incorporated to contextualize evolving therapies and their application in clinical practice.

RESULTS:

Current management of CLE follows a stepwise framework, with antimalarials and immunosuppressants forming the foundation of systemic therapy. However, many patients experience refractory disease, especially in chronic or hypertrophic subtypes. Advances in the understanding of CLE pathogenesis have led to the development of targeted biologics and small molecule agents that modulate Type I interferon signaling, B- and T-cell activation, and inflammatory cytokine pathways. Novel tools such as Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) and the Investigator Global Assessment for Cutaneous Lupus (CLA-IGA-R) are being validated to standardize disease assessment, while RNA tape sampling and real-world electronic health record (EHR)-based algorithms are enhancing research precision. Emerging therapies, such as belimumab, anifrolumab, litifilimab, deucravacitinib, and enpatoran, demonstrate promise in both clinical trials and real-world settings.

LIMITATIONS:

As a narrative review, this study is limited by the lack of systematic inclusion criteria and formal quality assessment of individual studies.

CONCLUSION:

Ongoing therapeutic innovation, guided by mechanistic insights and strengthened by the development of standardized outcome measures, is transforming the CLE landscape and advancing the goal of precision-based, durable disease control.

2025-12-01·Arthritis & Rheumatology

Pharmacodynamic Effects of Litifilimab in Lupus in a Randomized, Placebo‐Controlled Phase 2 Study: Rapid and Sustained Reductions in Type I Interferon‐Associated Gene Expression and Cytokines

Article

作者: Furie, Richard ; Franchimont, Nathalie ; Milliman, Eric ; Ferber, Kyle ; Werth, Victoria P. ; Barbey, Catherine ; Lahoud, Youmna ; Zoghbi, Jad ; Brown, Roland

Objective:

The pharmacodynamic effects of litifilimab on type I interferon (IFN) response and correlations with clinical outcomes were investigated in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE).

Methods:

Participants from part A (SLE) or part B (CLE with or without SLE) of the randomized phase 2 LILAC trial who received litifilimab (at 50 mg, 150 mg, or 450 mg) or a placebo were included. IFN gene signature (IFNGS) scores were assessed from whole‐blood samples using a 22‐gene panel in 120 and 131 participants (parts A and B, respectively). IFNα and other IFN‐regulated cytokine concentrations were measured in serum in 112 and 131 participants (parts A and B, respectively).

Results:

Most participants were IFNGS‐high at baseline (79–91%), and no baseline IFNGS‐low participant results were reported. In IFNGS‐high participants, litifilimab induced rapid, significant (nominal P < 0.05), and sustained reductions in IFNGS scores and IFNα concentrations versus a placebo for litifilimab at 450 mg in part A and for litifilimab at 150 mg and 450 mg in part B. In part A, IFNα reductions with litifilimab were correlated with clinical response measures. In part B, dose‐response relationships for IFNGS score and IFNα concentration were observed, similar to those for disease activity measured with the Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI‐A) score.

Conclusion:

Administration of litifilimab resulted in reductions in both IFNGS scores and IFNα concentrations, pharmacodynamic effects that correlated with clinical responses. These findings support the mechanism of action of litifilimab and its continued evaluation in larger studies of patients with SLE or CLE.image

2025-07-01·CPT-Pharmacometrics & Systems Pharmacology

An Integrative Mechanistic Model of Type 1 IFN‐Mediated Inflammation in Systemic Lupus Erythematosus

Article

作者: Volkova, Alina ; Tettamanti, Florencia ; Ugolkov, Yaroslav ; Kimko, Holly ; Sokolov, Victor ; Tang, Weifeng ; Peskov, Kirill ; Verma, Meghna

ABSTRACT:

Type I interferon (IFN1) pathway–targeting therapies represent a highly promising class of remedies for the treatment of systemic lupus erythematosus. However, the overall clinical benefit of these compounds is afflicted by marked variability. In this study, we developed a quantitative systems pharmacology model of type I IFN‐mediated inflammation and applied it for an indirect comparison of anifrolumab, sifalimumab, daxdilimab, and litifilimab pharmacodynamic response, represented in the model by the change in IFN1 gene signature (IFNGS). The model consists of 20 ordinary differential equations and 68 parameters, among which four systemic parameters (including one random effect) were estimated using patient‐level data from Phase IIb anifrolumab clinical trial. Within‐target and within‐pathway validation was performed using study‐level pharmacokinetics, IFNα, and/or IFNGS data from five anifrolumab, four sifalimumab, one daxdilimab, and one litifilimab trials. The model successfully captured overall trends in IFNGS at clinically relevant doses of these compounds and discriminated IFNGS response between patients with low (< 2.75) and high (≥ 2.75) baseline IFNGS. Overprediction of treatment benefit was observed for the low range of anifrolumab doses (100–150 mg every 4 weeks). In contrast, IFNGS response under 150 mg of daxdilimab was underpredicted, despite the accurate description of plasmacytoid dendritic cells and IFNα biomarkers. Results of the global sensitivity analysis revealed baseline IFNGS, IFNα, and IFNα fraction as key factors affecting treatment benefit the most. In terms of maximum IFNGS reduction, anifrolumab showed superior potential compared to sifalimumab, daxdilimab, and litifilimab (ΔIFNGS~25%), which was further enhanced in patients with high baseline IFNGS or IFNα (ΔIFNGS~50%–60%).

项与利替非利单抗相关的新闻（医药）

2026-02-28

·药研新药招募

【临床试验招募】红斑狼疮新药！首个国产重组抗BDCA2人源化单克隆抗体注射液招募活动性狼疮患者

患者招募一研究名称一项评价重组抗BDCA2人源化单克隆抗体注射液（SSGJ-626）在系统性红斑狼疮（SLE）受试者中的安全性、有效性、药代动力学及免疫原性特征的多中心、随机、双盲、安慰剂对照的Ib/II期临床研究二药物介绍 BDCA2靶向药进展： 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。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-2304，三生国建的SSGJ-626,映恩生物DDB-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。研究药物介绍： SSGJ-626是三生国健创新研发、拥有自主知识产权的重组抗BDCA2人源化单克隆抗体。BDCA2（血液树突状细胞抗原2）主要在浆细胞样树突状细胞（pDCQ）上表达，通过抑制干扰素产生来影响免疫应答，进而调控免疫系统。由于pDC产生的IFN/被认为是SLE的主要病理生理因素，因此BDCA2成为阻断SLE产生干扰素/的潜力靶点。红斑狼疮是一类慢性、反复发作的非器官特异性自身免疫病，其中SLE和CLE是两种主要类型。我国系统性红斑狼疮患病率高，患病人口众多，且每年新增确诊患者数量庞大。传统治疗以泛靶点抗炎和免疫抑制药物为主，但生物制剂为SLE治疗提供了新手段。SSGJ-626作为首款取得临床批件的国产BDCA2抗体，其研发成功有望为红斑狼疮患者带来新的治疗选择。随着生物制剂在红斑狼疮治疗中的使用范围和重要性不断扩大，SSGJ-626的市场前景值得期待。目前，SLE的传统治疗药物存在诸多局限性，如副作用大、疗效不稳定等。而生物制剂以其针对性强、疗效显著、副作用小等优点，逐渐成为SLE治疗的重要选择。用药介绍：给药方案：皮下注射，100 mg~400 mg，4周/次，用药时程: 双盲治疗，连续16周或20周，安全性随访8w，共12次访视三关键入选标准如果您符合以下要求，将有机会参与本次临床： ✅基本入选标准：年龄18-70，体重40-90kg，诊断SLE至少6个月； ANA或抗dsDNA抗体阳性、SLEDAI-2k≥6分，临床SLEDAI≥4分；目前正接受至少1种SLE标准治疗；SOC）药物（单药或联合）：a. 抗疟药：i. 基线访视前12 周开始使用且在基线访视时稳定剂量治疗≥4 周，或基线前停用≥4 周；ii. 允许的抗疟药和最高剂量如下：羟氯喹≤400 mg/天、氯喹≤250 mg/天、奎纳克林≤100 mg/天；b. 口服糖皮质激素：i. 基线访视时需稳定剂量治疗≥4 周；ii. 每日最大剂量≤20 mg/天的泼尼松或等效药物；c. 免疫抑制剂：i. 基线访视前12 周开始使用且在基线访视时稳定剂量治疗≥4 周，或基线前停用≥4 周；ii. 允许的免疫抑制剂（不超过1 种）和最大允许剂量如下：硫唑嘌呤（口服）≤200 mg/天或6-巯基嘌呤≤100 mg/天、甲氨蝶呤（口服、皮下或肌注）≤15 mg/周、吗替麦考酚酯（口服）≤2 g/天或霉酚酸（口服）≤2.16 g/天、环孢素（口服）≤400 mg/天、他克莫司（口服）≤4 mg/天、来氟米特（口服）≤20 mg/天、沙利度胺（口服）≤200 mg/天（若使用其他未列出的免疫抑制剂，剂量应不高于用于治疗SLE 的临床剂量）。四关键排除标准 1.混合性结缔组织病诊断（在筛选前的1 年内）或任何SLE 和系统性硬化重叠综合征病史（允许出现SLE 与继发性干燥综合征的重叠综合征，但受试者必须同时符合SLE 的分类标准）； 2具有临床意义的非SLE 相关性血管炎综合征的病史或当前诊断； 3.基线前2 个月内存在活动期重度狼疮肾炎，研究者认为研究方案规定的SOC疗法不足以治疗，应使用更积极的治疗方法，如添加环磷酰胺（IV）和/或高剂量脉冲皮质类固醇疗法（IV）或其他方案不允许的疗法；或尿蛋白-肌酐比值> 2.0 g/g 或肾小球滤过率估计值（eGFR）< 30 mL/min/1.73 m2（改良的简化MDRD 方程：eGFR[mL∙min-1∙(1.73 m2)-1]＝186×[Scr/88.4]-1.154×[年龄]-0.203×[女性×0.742] ×1.233）（注：Scr 为血肌酐值，单位为μmol/L）； 4.. 筛选时，乙型肝炎检验结果阳性【定义为：①乙肝表面抗原（HBsAg）阳性；②HBsAg 虽然阴性，但乙肝核心抗体（HbcAb）阳性（均须进一步通过乙肝病毒脱氧核糖核酸HBV DNA 检测，超过测定法的正常值上限 [ULN] 需要排除）】、丙肝病毒抗体（HCV Ab）阳性【须进一步通过丙肝病毒核糖核酸（HCV RNA）检测（超过测定法的ULN 需要排除）】、人类免疫缺陷病毒抗体（HIVAb）阳性、血清梅毒螺旋体抗体（TP Ab）阳性【若TPAb 阳性，须进一步通过快速血浆反应素试验（RPR）或甲苯胺红不加热血清试验（TRUST）检测（阳性需要排除）】；以上为主要入选标准，最终是否入选由研究者判断五项目获益 1 项目周期治疗期16/20周，全程32周左右，4周回院用药/次 2 项目补助 1.相关的检查和研究药物全部免费。 2.三甲医院专家的一对一问诊及病情管理。 3.患者全程参与补贴为1.1w左右，具体以研究中心为准 3 提交哪些病历 1、确诊病历（不限于门诊病历、住院病历） 2、近三个月用药记录（处方，最好有发票） 3、近1个月ANA、抗dsDNA抗体记录，其余的血、尿检查五开展医院六联系方式详情可咨询患者招募服务热线研究助理 13699739546

临床2期临床1期临床结果

2026-02-24

·科学研读社

系统性红斑狼疮治疗的新纪元：从免疫抑制到免疫稳态重建

一场与复杂性的持久战系统性红斑狼疮（SLE）是一种经典的、高度异质性的自身免疫性疾病。它像一个狡猾的对手，临床表现千变万化，从轻微的皮疹、关节痛到致命的肾炎、神经精神症状，不一而足。过去数十年，SLE的治疗主要依赖于糖皮质激素和广谱免疫抑制剂，这些药物虽能控制病情，却伴随着显著的毒副作用，严重影响患者的生活质量和长期预后。然而，随着对SLE发病机制的深入理解，我们正迎来一个治疗模式的根本性转变。SLE的治疗已不再满足于“压制”免疫系统，而是致力于“精准打击”致病通路，并最终走向“修复”免疫系统的最终目标。 SLE的高度异质性——治疗与研发的核心挑战 SLE的复杂性是其治疗和药物研发的最大障碍。临床异质性：患者之间受累器官、疾病严重程度和病程波动差异巨大，使得“一刀切”的治疗策略难以奏效。病理异质性： SLE并非单一疾病，而是由多种致病通路（如I型干扰素通路、B细胞活化通路、中性粒细胞胞外诱捕网NETosis等）交织而成的综合征。这意味着，针对单一通路的药物可能只对特定亚群有效。这种异质性直接导致了过去许多大型III期临床试验的失败。失败的原因包括：对照组因标准治疗（如高剂量激素）而反应率过高、未能筛选出最可能受益的生物标志物阳性人群、以及缺乏能全面反映疾病改善的评估工具。图1：系统性红斑狼疮发病机制总览从传统免疫抑制到精准靶向治疗尽管挑战重重，SLE的治疗在过去十年取得了里程碑式的突破。 1. B细胞靶向治疗：从失败到成功B细胞及其产生的自身抗体是SLE的核心驱动因素。利妥昔单抗（Rituximab）：作为首个B细胞清除剂，其在大型RCT中未能达到主要终点，一度让领域陷入低谷。但事后分析表明，这可能是由于组织内B细胞清除不彻底所致。奥妥珠单抗（Obinutuzumab）：新一代抗CD20单抗，凭借更强的B细胞清除能力，在狼疮肾炎（LN）的NOBILITY和REGENCY III期试验中均取得成功，显著提高了完全肾脏缓解率。贝利尤单抗（Belimumab）：全球首个获批用于SLE的生物制剂，通过抑制B细胞活化因子（BAFF），有效降低了疾病活动度、减少了激素用量，并延缓了器官损伤。其在LN中的BLISS-LN研究也证实了长期肾脏获益。泰它西普（Telitacicept）：一种新型融合蛋白，可同时抑制BAFF和APRIL，为B细胞靶向治疗提供了新选择。 2. I型干扰素（IFN-I）通路：点亮“干扰素签名”约50-90%的SLE患者存在IFN-I通路过度活化（即“干扰素签名”）。阿尼夫鲁单抗（Anifrolumab）：通过阻断IFN-I共用的受体（IFNAR），成为第二个获批的SLE生物制剂。它在皮肤和关节症状方面效果显著，有趣的是，其疗效似乎不受基线干扰素签名水平高低的影响，拓宽了适用人群。 3. 细胞内信号通路抑制剂：多点开花靶向细胞内的关键信号分子，可以同时抑制多条炎症通路。JAK/STAT通路：巴瑞替尼（Baricitinib）和乌帕替尼（Upadacitinib）等JAK抑制剂在II期试验中显示出对皮肤和关节病变的改善作用，目前正在进行III期验证。 BTK抑制剂：奥布替尼（Orelabrutinib）等药物通过抑制B细胞受体信号，在LN中展现出降低蛋白尿和自身抗体的潜力。钙调磷酸酶抑制剂：伏环孢素（Voclosporin）作为一种新型、药代动力学更优的药物，已获批用于LN，通过稳定足细胞骨架和抑制T细胞活化，有效诱导肾脏缓解。迈向治愈：免疫稳态的重建如果说精准靶向是“治标”，那么恢复免疫系统的自我平衡（免疫稳态）则是“治本”，代表着SLE治疗的终极梦想。 1. 调节性T细胞（Treg）SLE患者普遍存在Treg细胞数量减少和功能受损。低剂量白介素-2（IL-2LD）疗法旨在选择性扩增和激活Treg细胞，已在多项小型研究中显示出改善疾病活动度、减少激素用量的潜力。虽然一些工程化IL-2变体（muteins）的IIb期试验因未达主要终点而终止，但该策略的理论基础依然坚实。 2. CAR-T细胞疗法：重置免疫系统嵌合抗原受体T细胞（CAR-T）疗法最初用于血液肿瘤，如今在SLE领域实现了突破。通过靶向CD19阳性的B细胞，CAR-T疗法在十余例难治性SLE患者中实现了长期、无药缓解。其机制被认为是通过深度清除致病性B细胞，从而“重置”了紊乱的免疫系统。这一突破性进展，首次让人们看到了“功能性治愈”SLE的曙光。 3. 其他前沿探索血浆细胞清除：靶向CD38（如达雷妥尤单抗）或BCMA的疗法，旨在清除产生自身抗体的长寿浆细胞。FcRn 抑制剂：如尼泊利尤单抗（Nipocalimab），通过阻断新生儿Fc受体，加速致病性自身抗体的降解。浆细胞样树突状细胞（pDC）：作为I型干扰素的主要来源，靶向pDC表面标志物（如BDCA2）的抗体（如Litifilimab）正在临床开发中。图2：系统性红斑狼疮的治疗方案总览未来的挑战与机遇尽管前景光明，SLE治疗仍面临重大挑战：精准分层：如何利用可靠的生物标志物（如干扰素签名、特定自身抗体谱）将患者精准分入最合适的治疗路径，是提高药物成功率的关键。治疗降级（De-escalation）：如何在疾病得到良好控制后，安全地减少甚至停用药物（尤其是激素），以最小化长期毒性，是临床实践中的核心难题。中枢神经系统狼疮（NPSLE）：针对这一严重且难以治疗的并发症，目前仍缺乏有效的特异性疗法。结语：希望与复杂性并存系统性红斑狼疮的治疗正处在一个激动人心的转折点。从过去有限的、充满毒性的选择，到如今日益丰富的精准靶向武器库，再到未来有望实现免疫系统“重置”的疗法，科学界为患者带来的希望前所未有。然而，SLE固有的复杂性和异质性提醒我们，通往“治愈”之路依然漫长。未来的成功将依赖于更深入的疾病分型、更智能的临床试验设计、以及对免疫稳态重建机制的持续探索。虽然障碍依然存在，但“持久缓解甚至治愈的希望正在上升”。这场与复杂性的持久战，正迎来属于患者的胜利曙光。往期精选文章：治愈自身免疫性疾病的开发竞赛自身免疫性疾病药物靶点的开发趋势 CAR-T疗法用于缓解自身免疫性疾病

临床3期临床结果免疫疗法

2026-02-11

·谈医说药

2026年02月11日药品临床试验默示许可

序号受理号药品名称申请人名称适应症注册分类 1 CXSL2501018 HL08 华兰生物工程股份有限公司;华兰基因工程有限公司拟用于肥胖患者的体重控制。 1 2 JXSB2600012 PF-08046054 (注射用冻干粉针) Pfizer Inc. 本品适用于治疗既往接受过含铂化疗、接受或未接受过程序性死亡受体-1（PD-1）或程序性死亡配体1抑制剂（PD-L1）治疗的局部晚期不可切除或转移性非小细胞肺癌成年患者，这些患者经过市售的或经验证的方法检测确定其肿瘤表达PD-L1表达≥1%。 1 3 JXHB2500174 LOU064片 Novartis Pharma AG 中重度化脓性汗腺炎 1 4 JXHB2500173 LOU064片 Novartis Pharma AG 中重度化脓性汗腺炎 1 5 CXHL2501351 GEN-725片河南真实生物科技有限公司 GEN-725与PD-1单抗联合用于治疗晚期实体瘤 2.4 6 CXHL2501350 GEN-725片河南真实生物科技有限公司 GEN-725与PD-1单抗联合用于治疗晚期实体瘤 2.4 7 CXHL2501343 注射用西罗莫司（白蛋白结合型）石药集团中奇制药技术（石家庄）有限公司注射用西罗莫司（白蛋白结合型）联合SYS6023用于治疗不可切除的局部晚期或转移性乳腺癌。 2.4 8 CXSL2501062 托莱西单抗注射液信达生物制药（苏州）有限公司单药用于治疗非家族性高胆固醇血症和混合型血脂异常的成人患者。治疗用生物制品:2.2类 9 CXSL2501052 阿得贝利单抗注射液上海盛迪医药有限公司;苏州盛迪亚生物医药有限公司阿得贝利单抗联合化疗用于可切除的局部进展期胃癌或胃食管结合部癌 2.2 10 CXSL2501060 信迪利单抗注射液信达生物制药（苏州）有限公司 IBI310联合信迪利单抗和贝伐珠单抗伴或不伴化疗用于既往未接受过系统治疗的不可切除或转移性肝细胞癌的一线治疗。 2.2 11 CXSL2501057 贝伐珠单抗注射液信达生物制药（苏州）有限公司 IBI310联合信迪利单抗和贝伐珠单抗伴或不伴化疗用于既往未接受过系统治疗的不可切除或转移性肝细胞癌的一线治疗。 2.2 12 CXSL2501055 SYS6023 石药集团巨石生物制药有限公司 SYS6023联合用药用于治疗不可切除的局部晚期或转移性乳腺癌。 1 13 CXSL2501054 MRG006A 乐普生物科技股份有限公司本品联合免疫检查点抑制剂、靶向治疗药物用于晚期肝癌患者的治疗 1 14 CXSL2501063 IMM0306 宜明昂科生物医药技术（上海）股份有限公司 IgG4相关性疾病（IgG4-RD） 1 15 CXSL2501061 IBI310 信达生物医药科技（杭州）有限公司;信达生物制药（苏州）有限公司 IBI310联合信迪利单抗和贝伐珠单抗伴或不伴化疗用于既往未接受过系统治疗的不可切除或转移性肝细胞癌的一线治疗。 2.2 16 CXHB2500326 HRS-1893片山东盛迪医药有限公司 1.拟用于治疗肥厚型心肌病以及心肌肥厚导致的心力衰竭；2.拟用于治疗射血分数保留的心力衰竭。 1 17 CXHL2501348 JAB-23E73片北京加科思新药研发有限公司 JAB-23E73联合白蛋白结合型紫杉醇和吉西他滨治疗KRAS基因改变的转移性胰腺导管腺癌患者。 1 18 CXHL2501347 JAB-23E73片北京加科思新药研发有限公司 JAB-23E73联合白蛋白结合型紫杉醇和吉西他滨治疗KRAS基因改变的转移性胰腺导管腺癌患者。 1 19 CXHL2501346 JAB-23E73片北京加科思新药研发有限公司 JAB-23E73联合白蛋白结合型紫杉醇和吉西他滨治疗KRAS基因改变的转移性胰腺导管腺癌患者。 1 20 CXSL2501053 DXC006 杭州多禧生物科技有限公司小细胞肺癌 1 21 CXHL2501337 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 22 CXHL2501336 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 23 CXHL2501335 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 24 CXHL2501334 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 25 CXHL2501333 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 26 JXSB2500147 Litifilimab (BIIB059) Biogen Idec Research Limited 用于治疗正在接受非生物制剂标准疗法的成人活动期系统性红斑狼疮（SLE ）。有或无全身表现且抗疟药治疗反应不佳和/或不耐受的活动性亚急性皮肤型红斑狼疮（SCLE）和/或慢性皮肤型红斑狼疮（CCLE）。 1 27 CXHB2500325 CG2001 北京辰光医药科技有限公司;辰光（天津）制药有限公司本品用于男性雄激素性脱发患者的治疗。化学药品 28 JXHL2500387 Eloralintide注射液 Eli Lilly and Company 超重或肥胖患者的中重度阻塞性睡眠呼吸暂停 1 29 JXHL2500386 Eloralintide注射液 Eli Lilly and Company 超重或肥胖患者的中重度阻塞性睡眠呼吸暂停 1 30 JXHL2500385 Eloralintide注射液 Eli Lilly and Company 超重或肥胖患者的中重度阻塞性睡眠呼吸暂停 1 31 JXHL2500384 Eloralintide注射液 Eli Lilly and Company 超重或肥胖患者的中重度阻塞性睡眠呼吸暂停 1 32 JXHL2500383 Eloralintide注射液 Eli Lilly and Company 本品用于成年肥胖或者超重患者在饮食和运动基础上的长期体重管理。 1 33 JXHL2500382 Eloralintide注射液 Eli Lilly and Company 本品用于成年肥胖或者超重患者在饮食和运动基础上的长期体重管理。 1 34 JXHL2500381 Eloralintide注射液 Eli Lilly and Company 本品用于成年肥胖或者超重患者在饮食和运动基础上的长期体重管理。 1 35 JXHL2500380 Eloralintide注射液 Eli Lilly and Company 本品用于成年肥胖或者超重患者在饮食和运动基础上的长期体重管理。 1 36 JXHL2500377 Eloralintide注射液 Eli Lilly and Company 肥胖或超重合并膝骨关节炎疼痛 1 37 JXHL2500376 Eloralintide注射液 Eli Lilly and Company 肥胖或超重合并膝骨关节炎疼痛 1 38 JXHL2500375 Eloralintide注射液 Eli Lilly and Company 肥胖或超重合并膝骨关节炎疼痛 1 39 JXHL2500374 Eloralintide注射液 Eli Lilly and Company 肥胖或超重合并膝骨关节炎疼痛 1 40 CXSL2600068 BG-A3004注射液广州百济神州生物制药有限公司免疫介导性皮肤病 1 41 CXSL2501000 R01注射液杭州纽安津生物科技有限公司根治术后具高危复发风险的恶性实体瘤患者，主要包括胰腺癌、食管癌、肝细胞癌、胆道恶性肿瘤、胃癌以及结直肠癌等。 1 42 CXSL2501002 GKL-006注射液北京基因启明生物科技有限公司中重度银屑病 1 43 CXSL2500998 流感病毒裂解疫苗（高剂量）成大生物（本溪）有限公司;辽宁成大生物股份有限公司接种本疫苗后，可刺激机体产生抗流感病毒的免疫力。用于预防疫苗相关型别的流感病毒引起的流行性感冒。 3.2 44 CXSL2501188 OVV-01注射液上海荣瑞医药科技有限公司 OVV-01注射液静脉及瘤内给药联合治疗晚期实体瘤 1 45 CXSL2501187 OVV-01注射液（静脉）上海荣瑞医药科技有限公司 OVV-01注射液静脉及瘤内给药联合治疗晚期实体瘤 1 46 CXSB2500226 U16注射液上海优卡迪智造生命科技有限公司;上海优卡迪生物医药科技有限公司复发或难治性非霍奇金淋巴瘤治疗用生物制品

100 项与利替非利单抗相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
盘状红斑狼疮	临床3期	美国	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	中国	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	日本	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	阿根廷	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	比利时	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	巴西	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	保加利亚	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	加拿大	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	智利	Biogen Idec Research Ltd.	2024-02-21
盘状红斑狼疮	临床3期	哥伦比亚	Biogen Idec Research Ltd.	2024-02-21

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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 \| 盘状红斑狼疮	264	Placebo (Part A: Placebo)	遞壓遞鑰襯鹹窪膚鏇觸(糧鑰蓋鏇窪鏇鏇蓋鹹艱) = 淵壓網憲淵鹹積襯網鑰鏇廠糧觸觸餘艱醖獵構 (製願願遞築糧糧網顧鏇, 10.3) 更多	-	2023-05-15
				BIIB059 (litifilimab) (Part A: BIIB059 450 mg)	遞壓遞鑰襯鹹窪膚鏇觸(糧鑰蓋鏇窪鏇鏇蓋鹹艱) = 選壓餘遞願願選製網蓋鏇廠糧觸觸餘艱醖獵構 (製願願遞築糧糧網顧鏇, 8.7) 更多
NCT02847598 (LILAC, Pubmed \| N Engl J Med)	临床2期	系统性红斑狼疮 BDCA2	132	Litifilimab 450 mg	蓋蓋蓋膚網夢餘觸鏇壓(鏇製網簾窪顧齋淵蓋廠): P-Value = 0.04 更多	积极	2022-09-08
				Placebo
NCT02847598 (LILAC, Pubmed \| N Engl J Med)	临床2期	皮肤红斑狼疮	132	Litifilimab 50 mg	鬱壓齋醖簾膚獵網構觸(夢築醖夢觸壓廠鏇網選) = Litifilimab was associated with one case of herpes zoster infection 蓋糧構淵蓋壓積襯簾簾 (艱鏇繭獵壓壓鬱遞膚獵 ) 更多	积极	2022-07-28
				Litifilimab 150 mg
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	繭鑰願選觸範鹹鏇鏇廠(醖糧遞觸鹽製窪遞餘積) = 顧觸鹽糧獵蓋積積鏇鹹醖觸衊顧範願遞遞蓋夢 (壓壓觸鑰夢築鹹壓淵獵 ) 更多	积极	2022-06-01
				Placebo	繭鑰願選觸範鹹鏇鏇廠(醖糧遞觸鹽製窪遞餘積) = 遞顧範壓築憲衊夢衊憲醖觸衊顧範願遞遞蓋夢 (壓壓觸鑰夢築鹹壓淵獵 ) 更多
NCT02847598 (LILAC study, EULAR2022)	临床2期	皮肤红斑狼疮 BDCA2	-	BIIB059	願糧壓憲網積艱膚鬱蓋(廠衊鬱鏇膚鏇鏇醖淵觸) = 築淵製醖廠鹹襯鏇齋衊齋觸襯夢淵網鏇繭醖醖 (製簾鑰觸鬱築選範齋齋 ) 更多	积极	2022-06-01
NCT02847598 (LILAC, ACR2020) 人工标引	临床2期	系统性红斑狼疮	120	BIIB059	構製齋夢壓獵繭構獵膚(鬱餘鏇顧鹽積築鬱糧積) = 餘淵鬱選糧築膚構鑰廠製襯鬱淵齋醖觸鹹積鏇 (簾夢壓鹹願糧網觸衊餘, 1.2) 更多	积极	2020-11-07
				Placebo	構製齋夢壓獵繭構獵膚(鬱餘鏇顧鹽積築鬱糧積) = 積醖鏇齋壓積獵範繭鏇製襯鬱淵齋醖觸鹹積鏇 (簾夢壓鹹願糧網觸衊餘, 1.3) 更多
NCT02847598 (LILAC, EULAR2020)	临床2期	皮肤红斑狼疮	132	BIIB059 50 mg	願選糧糧膚網願築蓋襯(顧簾鑰鏇範製鑰鑰構鑰) = 62 (62.6%) 80 (60.6%) 壓遞醖糧鹹願構鹹願網 (艱築鹽鹹繭範選遞糧簾 ) 更多	积极	2020-06-03
				BIIB059 150 mg
NCT02847598 (Pubmed \| J Pharmacokinet Pharmacodyn)	临床2期	皮肤红斑狼疮	264	BIIB059	淵鬱網鬱選衊網醖窪衊(願糧範蓋鹹簾選繭鏇膚) = 選壓築襯艱構淵蓋醖憲網憲鹹壓壓鏇艱夢鬱鏇 (壓製範衊齋齋衊憲網鏇 ) 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	獵醖窪齋鏇膚襯衊衊壓(範遞醖遞淵鏇築願獵艱) = 廠獵膚衊遞鑰築蓋網鑰鹹製齋衊艱繭鬱繭淵構 (獵艱蓋鹹憲鹽製艱選鬱 ) 更多	积极	2019-03-01
				Placebo	獵醖窪齋鏇膚襯衊衊壓(範遞醖遞淵鏇築願獵艱) = 壓淵衊衊製鹹構簾鏇艱鹹製齋衊艱繭鬱繭淵構 (獵艱蓋鹹憲鹽製艱選鬱 ) 更多
NCT02106897 (EULAR2018)	临床1期	BDCA2 on pDC	-	BIIB059 20 mg/kg IV	遞憲窪網鬱網觸壓鏇廠(鑰觸餘鏇積製網壓願構) = 製積獵簾廠壓觸選繭鹹淵糧餘窪顧艱鏇壓繭餘 (廠簾範獵餘觸襯淵繭遞 ) 更多	-	2018-06-13
				BIIB059 20, 50 or 150 mg SC	襯構顧鑰餘夢鑰範鑰遞(餘獵糧鏇觸鑰網襯鏇鏇) = 範憲積夢積築積齋鹹鹹顧鹹範鏇積淵顧窪鹽築 (範積鑰糧鏇製餘鬱網窪 ) 更多