来金珠单抗(Lebrikizumab) - 药物靶点：IL-13_在研适应症：特应性皮炎，慢性鼻窦炎伴鼻息肉，常年性变应性鼻炎_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

ANTI-IL-13、Lebrikizumab (genetical recombination) (JAN)、Lebrikizumab (USAN/INN)

+ [13]

靶点

IL-13

作用方式

抑制剂

作用机制

IL-13抑制剂(白细胞介素-13抑制剂)

治疗领域

免疫系统疾病遗传病与畸形皮肤和肌肉骨骼疾病+ [3]

在研适应症

特应性皮炎慢性鼻窦炎伴鼻息肉常年性变应性鼻炎+ [3]

非在研适应症

气道病变气道阻塞过敏性哮喘+ [4]

原研机构

Genentech, Inc.

在研机构

Almirall SA

Eli Lilly & Co.Eli Lilly Canada, Inc.

+ [3]

非在研机构

Hoffmann-La Roche, Inc.

Genentech, Inc.Tanox, Inc.

最高研发阶段批准上市

首次获批日期

欧盟 (2023-11-16),

特应性皮炎

最高研发阶段(中国)临床3期

特殊审评快速通道 (美国)

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结构/序列

Sequence Code 142719L

来源: *****

Sequence Code 9082543H

来源: *****

关联

62

项与来金珠单抗相关的临床试验

NCT06906497

/ Not yet recruiting临床4期IIT

Mechanism of Action for Lebrikizumab in Moderate-to-severe Atopic Dermatitis

This research is studying a drug already approved for the treatment of atopic dermatitis (AD). This research collects health-related information and blood and skin samples to understand if the study drug, lebrikizumab, leads to long-term improvement in AD skin.

开始日期2025-04-01

申办/合作机构

University of Michigan

[+2]

NCT06921759

/ Not yet recruiting临床3期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis

The main purpose of this study is to assess the efficacy of lebrikizumab versus placebo on skin lesions in adults and adolescent participants with atopic hand and foot dermatitis.
This study lasts up to 32 weeks, including a 6-week screening period, a 16-week treatment period, and a safety follow-up visit 12 weeks after the last dose.

开始日期2025-04-01

申办/合作机构

Eli Lilly & Co.

CTR20241693

/ Recruiting临床3期

一项在接受鼻内皮质类固醇背景治疗的慢性鼻窦炎伴鼻息肉成人受试者中评估 Lebrikizumab/LY3650150 的有效性和安全性的 III 期、多中心、随机、双盲、安慰剂对照、平行组研究

主要目的: 评估 Lebrikizumab 250 mg Q2W 与安慰剂（PBO ）相比在降低接受鼻内皮质类固醇（INCS ）背景治疗的受试者第 24 周时的鼻塞严重程度和内镜鼻息肉评分（NPS ）方面的有效性关键次要目的：评估 Lebrikizumab 在减轻受试者体征和症状方面的有效性

开始日期2024-08-14

申办/合作机构

礼来苏州制药有限公司

[+2]

100 项与来金珠单抗相关的临床结果

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100 项与来金珠单抗相关的转化医学

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100 项与来金珠单抗相关的专利（医药）

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177

项与来金珠单抗相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Rosacea-like skin reaction under treatment with dupilumab for atopic dermatitis

Article

作者: Augustin, M. ; Wagner, J. N. ; Grote, C. ; Zirkenbach, F.

PURPOSE:

Dupilumab is a widely recommended treatment for moderate-to-severe atopic dermatitis (AD), with known ocular side effects but less frequent cutaneous reactions.

MATERIAL AND METHODS:

This case report details a 52-year-old female patient with atopic dermatitis treated with dupilumab. After an initially successful treatment, the patient developed a rosacea-like dermatitis. At first, dupilumab was continued alongside doxycycline, metronidazole gel and ivermectin cream.

RESULTS:

Following a worsening of her skin condition, dupilumab was discontinued. Lebrikizumab was introduced, leading to significant regression of the lesions.

CONCLUSIONS:

This case highlights a rare paradoxical skin reaction to dupilumab, potentially linked to the blockade of IL-4Rα, which may shift the immune response towards a Th1/Th17 phenotype. The findings suggest that alternative therapies, such as IL-13 inhibitors, should be considered when cutaneous side effects arise during dupilumab treatment.

2025-03-18·BRITISH JOURNAL OF DERMATOLOGY

Long-term management of moderate-to-severe atopic dermatitis with lebrikizumab and concomitant topical corticosteroids: a 68-week randomized double-blind placebo-controlled phase III trial in Japan (ADhere-J)

Article

作者: Igawa, Ken ; Morisaki, Yoji ; Kataoka, Yoko ; Shimizu, Ryosuke ; Torisu-Itakura, Hitoe ; Katoh, Norito ; Tanaka, Akio ; Yamamoto, Chie ; Takahashi, Hidetoshi

Abstract:

Background:

Moderate-to-severe atopic dermatitis (AD) affects the quality of life of patients. More treatment options are urgently needed to manage this chronic disease. Lebrikizumab is a monoclonal antibody that binds to interleukin-13, a key mediator in AD pathogenesis. In Japanese patients, lebrikizumab has been evaluated through week 16 in the randomized placebo-controlled phase III ADhere-J study.

Objectives:

To evaluate the long-term efficacy and safety of lebrikizumab in combination with topical corticosteroids (TCS) in the ADhere-J study.

Methods:

Patients aged ≥12 years weighing ≥ 40 kg with moderate-to-severe AD and receiving either subcutaneous lebrikizumab 250 mg every 2 weeks (Q2W)/every 4 weeks (Q4W) or placebo during the 16-week induction period were evaluated during the long-term maintenance period from week 16 to week 68. Responders achieved the co-primary endpoints at week 16: an Investigator’s Global Assessment score of 0 or 1 [IGA (0,1)] with ≥ 2-point improvement from baseline and/or ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI 75). In this analysis, week 16 responders received lebrikizumab 250 mg Q2W or Q4W combined with TCS during the maintenance period (maintenance primary population; MPP); week 16 per-protocol nonresponders received lebrikizumab Q2W with TCS (maintenance escape population; MEP). Major endpoints included IGA (0,1) with ≥ 2-point improvement from baseline and EASI 75 through week 68. Other outcomes included quality of life, itch and serum thymus and activation-regulated chemokine. The trial was registered with ClinicalTrials.gov (NCT04760314).

Results:

At week 68, 66–81% of 103 patients in the MPP and 32–38% of 168 patients in the MEP achieved IGA (0,1) with ≥ 2-point improvement from baseline. EASI 75 was maintained by 83–89% of patients in the MPP, while 71–80% of patients in the MEP achieved this outcome by week 68. Across treatment arms, patients in the MPP tended to maintain improvements recorded at week 16, while patients in the MEP steadily improved across the maintenance period. No new safety signals were reported, and most treatment-emergent adverse events were mild or moderate in severity in both populations. Safety outcomes were consistent with previous reports for lebrikizumab treatment in global studies.

Conclusions:

These results support the use of lebrikizumab in combination with TCS for the treatment of moderate-to-severe AD in the Japanese population in the long term.

2025-03-01·Dermatology and Therapy

Lebrikizumab vs Other Systemic Monotherapies for Moderate-to-Severe Atopic Dermatitis: Network Meta-analysis of Efficacy

Review

作者: Curteis, Tristan ; Karlsson, Andrei ; Ezzedine, Khaled ; Kamata, Masahiro ; Silverberg, Jonathan I ; Gallo, Gaia ; Puig, Luis ; Chovatiya, Raj ; Wiseman, Marni ; Akmaz, Buelent ; Bieber, Thomas ; Del Rosso, James ; Irvine, Alan D ; Paller, Amy S ; Beck, Lisa ; Johansson, Erin ; Dossenbach, Martin ; Casillas, Marta ; Gold, Linda Stein ; Foley, Peter

INTRODUCTION:

A systematic literature review and network meta-analysis (NMA) were conducted to compare the short-term efficacy of lebrikizumab to other biologic and Janus kinase (JAK) inhibitor monotherapies approved for moderate-to-severe atopic dermatitis in adults and adolescents.

METHODS:

The NMA included randomized, double-blind, placebo-controlled monotherapy phase 2 and 3 trials of biologics (lebrikizumab 250 mg every 2 weeks [Q2W], dupilumab 300 mg Q2W, and tralokinumab 300 mg Q2W) and JAK inhibitors (abrocitinib 100/200 mg daily, baricitinib 2/4 mg daily, and upadacitinib 15/30 mg daily) at approved doses. Efficacy outcomes included the proportions of patients achieving Eczema Area and Severity Index (EASI) improvement, an Investigator Global Assessment of 0 or 1 (IGA 0/1), and a ≥ 4-point improvement in pruritus/itch numeric rating scale score at 12 weeks (abrocitinib) or 16 weeks (other treatments). Itch was also assessed at week 4. A Bayesian NMA employing baseline risk-adjusted random effects models was used to estimate treatment differences.

RESULTS:

Twenty-two monotherapy studies involving 8531 patients were included in the NMA. By week 12/16, lebrikizumab had superior odds of achieving IGA 0/1 and itch improvement compared to baricitinib and tralokinumab; similar odds to dupilumab, abrocitinib, and upadacitinib 15 mg; and inferior odds to upadacitinib 30 mg. Additionally, lebrikizumab had a higher probability of improving EASI than baricitinib 2 mg; similar probability to baricitinib 4 mg, tralokinumab, dupilumab, abrocitinib, and upadacitinib 15 mg; and lower probability than upadacitinib 30 mg daily. At week 4, lebrikizumab had superior odds of improving itch compared to tralokinumab; similar odds to baricitinib, dupilumab, and abrocitinib 100 mg; and inferior odds to abrocitinib 200 mg and upadacitinib.

CONCLUSION:

Among biologics, lebrikizumab was comparable to dupilumab and superior to tralokinumab in improving response rates at week 16. Upadacitinib 30 mg was the only JAK inhibitor with superior response rates compared to lebrikizumab.

246

项与来金珠单抗相关的新闻（医药）

2025-03-28

·Cytiva学堂

医药创新星河璀璨：2024年Biacore助力FDA获批药物盘点

2024年，美国食品药品监督管理局（FDA）完美收官，全年共批准13款抗体新药，创下历史新高！至此，FDA批准的抗体药物累计达143款，标志着生物医药正式迈入“精准制导”的新纪元。13款抗体新药中，3款为双特异性抗体，10款为单抗，如同繁星点亮了多个疾病治疗的“无人区”。Biacore team将选取2024年度最具代表性的获批案例，看Biacore如何化身分子尺度的‘动态解码器’在药物发现的混沌中搭建起理性设计的桥梁，让更多抗体药物跨越研发鸿沟，加速抵达拯救生命的终点。抗癌战场：中国创新闪耀国际舞台抗肿瘤领域独占6席，印证抗体药物在癌症治疗中的核心地位。百济神州的PD-1单抗替雷利珠单抗（tislelizumab-jsgr，商品名百泽安，TEVIMBRA）斩获食管癌适应症，成为中国自主研发的又一里程碑。Tislelizumab是一种针对PD-1的人源化免疫球蛋白G4（IgG4）变体单克隆抗体，可与人类PD-1的细胞外结构域结合。它竞争性地阻断PD-L1和PD-L2的结合，抑制PD-1介导的负信号传导，并在体外细胞试验中增强T细胞的功能活性。2024年3月被FDA批准用于治疗既往接受过化疗的不可切除、复发、局部晚期或转移性食管鳞状细胞癌的成年患者。其在整个研发过程中大量使用到了Biacore的检测数据。通过Biacore 8K系统（CM5芯片固定PD-1 Fc融合蛋白），研究团队对比了替雷利珠单抗与已上市抗体Pembrolizumab、Nivolumab的结合参数（图1）。实验显示，替雷利珠单抗的KD较Pembrolizumab和Nivolumab低1-2个数量级。其核心机制在于极低的解离速率，较Pembrolizumab减缓80倍，结合半衰期延长30倍以上。这一特性预示了其在体内更持久的靶点占据能力。图1：Tislelizumab、Pembrolizumab和Nivolumab的表征数据通过PD-1/替雷利珠单抗Fab复合物的晶体结构解析，研究团队发现抗体通过重链CDR3（HCDR3）与轻链CDR1/2（LCDR1/2）形成广泛的结合界面，其中PD-1的CC'环成为关键结合区域。为验证这一发现，团队利用丙氨酸扫描突变结合Biacore分析，发现CC'环突变体（如Q75A、T76A、D77A）导致替雷利珠单抗的KD值显著上升（图2）。图2：CC'环突变体亲和力数据Biacore数据与结构分析的整合表明，替雷利珠单抗的结合表位与PD-L1的重叠面积达80%，而Pembrolizumab和Nivolumab的重叠面积仅为66%和44%。这一差异在细胞水平的P3Z实验中得到验证：替雷利珠单抗在3 μg/mL浓度下可完全阻断PD-L1信号（IL-2分泌抑制>99%），而Pembrolizumab和Nivolumab仅能达到80%和81%的阻断率。其机制源于替雷利珠单抗的轻链（VL）直接占据PD-L1的结合位点，形成空间位阻效应。结合结构生物学与功能实验，该研究为抗体药物的理性设计提供了范本。辉瑞新型血友病疗法：TFPI抑制HYMPAVZI美国FDA批准辉瑞（Pfizer）药品Hympavzi（marstacimab）用于常规预防或减少12岁及以上血友病A和血友病B成人和儿童患者的出血，这些患者体内不含凝血因子VIII与IX抑制剂（中和抗体）。Marstacimab是一种人源化IgG1单克隆抗体，通过特异性结合TFPI的Kunitz 2（K2）结构域，中和TFPI的K2活性，释放FXa和FVIIa的促凝功能，绕过内源性凝血途径缺陷（如FVIII/FIX缺乏），直接增强凝血酶生成。在该药的研发与申报中，SPR实验显示，Marstacimab对人类TFPI K2结构域的解离常数（Kd）为2.63 ± 0.08 nM，对K1K2复合结构域的Kd为7.9 ± 0.33 nM，但不与TFPI的K1域结合。此外，Marstacimab对不同物种的TFPI K1K2域均表现出相似的抑制作用，具体数值如下：图3：Marstacimab对不同物种的TFPI K1K2域的亲和力数据Marstacimab不与TFPI的K1结构域结合，其促凝血活性完全依赖于对K2和K1K2结构域的结合与抑制。这种高选择性结合机制使其在增强凝血功能的同时，减少了潜在的副作用风险。此外，辉瑞研发人员还进行了Marstacimab与Concizumab（另一种抗TFPI单克隆抗体）的对比研究，见下表。基于结合亲和力，研发人员预测Marstacimab的临床有效剂量在100至300毫克之间。Marstacimab虽亲和力略低，但其平缓的药效动力学特性可能降低剂量依赖性毒性风险。图4：Marstacimab与Concizumab对人K1K2及小鼠K1K2的亲和力Marstacimab通过靶向TFPI的K2结构域，为血友病患者提供了一种“无需依赖凝血因子”的创新疗法。其每周一次的皮下注射方案、明确的疗效数据（III期研究ABR降低>65%）及Fc沉默化设计，标志着血友病治疗从“替代缺陷”到“调控内源”的范式转变。2019年FDA授予的快速通道资格（FTD）进一步凸显其临床价值，未来有望成为全球血友病标准治疗的重要组成。礼来新型特应性皮炎疗法：IL-13抑制剂Ebglyss特应性皮炎（AD）是一种以慢性炎症、剧烈瘙痒和皮肤屏障功能受损为特征的免疫介导性疾病。传统治疗方法主要依赖于糖皮质激素和免疫抑制剂，但长期使用这些药物可能引发皮肤萎缩及全身性副作用。尽管新型生物制剂（如IL-4/IL-13抑制剂Dupixent）在治疗中表现出一定疗效，但仍有部分患者对其应答不足。礼来公司开发的Ebglyss（Lebrikizumab）作为一种高选择性的IL-13单克隆抗体，为患者提供了更为精准的靶向治疗选择。Lebrikizumab是一种人源化IgG4单克隆抗体，通过特异性结合游离的IL-13蛋白，阻断其与IL-13受体（IL-13Rα1/IL-4Rα复合物）的相互作用，从而抑制下游JAK-STAT信号通路的激活，减少炎症细胞的浸润和瘙痒信号的传递，同时部分恢复皮肤屏障功能。2023年，礼来公司的研究人员发表了一项研究，该研究利用Biacore T200技术对Lebrikizumab、Cendakimab和Tralokinumab三种单克隆抗体与糖基化及非糖基化IL-13的结合能力进行了测试。研究结果显示，这三种单克隆抗体均能够与糖基化和非糖基化的IL-13结合。尽管它们的结合速率相近，但Lebrikizumab对糖基化和非糖基化人IL-13的解离速率最慢，因此其整体亲和力显著高于Cendakimab和Tralokinumab。图5：Lebrikizumab、Cendakimab和Tralokinumab对糖基化和非糖基化IL-13的结合能力此外，研究人员又进一步利用Biacore来评估抗体是否结合在IL-13的相同表位。当IL-13预先结合Cendakimab或Tralokinumab时，Lebrikizumab仍能结合IL-13；而Cendakimab和Tralokinumab无法结合已与自身或其他抗体结合的IL-13。这一结果表明：Tralokinumab与Cendakimab结合IL-13的重叠表位；Lebrikizumab结合IL-13的不同表位，且其表位空间不与其他两种抗体冲突。综上所述，Lebrikizumab凭借其高亲和力和独特的表位结合特性，在IL-13抑制剂中展现出核心优势。这些发现对于理解不同IL-13单克隆抗体在AD治疗中的潜在差异具有重要意义，并可能为个体化治疗提供新的见解。礼来阿尔茨海默新药Donanemab美国食品药品监督管理局（FDA）批准Kisunla（通用名：Donanemab）用于治疗早期有症状的阿尔茨海默病（AD）成人患者，包括轻度认知障碍患者和处于神经退行性疾病轻度痴呆阶段的患者。Donanemab是一种人源化(IgG1)单克隆抗体，可以减少淀粉样β斑块，用于治疗针对患有轻度认知障碍或轻度痴呆症的患者。在Kisunla的申报材料中， Biacore被用于药靶的亲和力检测，以及结合表位的鉴定。首先利用Biacore测定了Donanemab与人源AβN3pE-42肽结合的亲和力（KD）最高达到了0.82±0.05 nM；与非焦谷氨酸人Aβe3-16 (KD = 420 nM)相比，对c端截断形式Aβ N3pE-16的亲和力仍然相对较高(KD = 3±2 nM)。未检测到与人源Aβ1-40或小鼠AβN3pE-16的结合。同时，结合了Biacore的实验结果鉴定得到Donanemab与人源AβN3pE-16结合的表位定位在n端（AβN3pE-7）的5个氨基酸上。图6：Donanemab申报材料全球首款HER2双抗Zanidatamab11月20日，Jazz Pharmaceuticals宣布Zanidatamab（商品名：Ziihera）获FDA加速批准上市，用于治疗既往接受过治疗的不可切除或转移性HER2阳性（HER2+，标准为IHC 3+）胆道癌（BTC）成人患者。该药物是第一款获批上市的HER2双抗。该药物获批前小编已经对该抗体进行了详细报道。回顾点击：新型双特异性抗体Zanidatamab结构设计及活性验证思路Biacore用于定量分析双特异性抗体zanidatamab及其前体与HER2胞外域（ECD）的结合动力学参数。通过单循环动力学实验（single-cycle kinetics），作者验证了zanidatamab对HER2的亚纳摩尔级高亲和力，并比较了其与亲本抗体的差异（如抗ECD2 Fab经工程优化后亲和力提升8.8倍）。作者进一步运用Biacore进行了结合模式验证，通过调节芯片表面抗体捕获密度，Biacore实验揭示了zanidatamab的反式结合特性：在高密度条件下，抗体通过同时结合两个HER2分子（分别靶向ECD2和ECD4）形成交联复合物，导致kd显著降低（密度依赖性）。而对照抗体trastuzumab（仅靶向ECD4）的kd无密度依赖性，证实其为顺式结合。这一结果为后续观察的HER2簇状聚集和补体依赖的细胞毒性（CDC）提供了机制基础。随后在抗体工程过程中，Biacore被用于筛选亲和力优化的抗ECD2 Fab突变体。通过对比野生型与突变体的结合参数（KD从15 nM提升至1.7 nM），作者确认了结构导向的亲和力提升策略的有效性，确保双特异性抗体能够高效交联HER2受体。结合分析型超速离心（AUC）和冷冻电镜（cryo-EM）数据，Biacore结果进一步支持了zanidatamab诱导的HER2多聚体形成，为其独特的生物学功能（如CDC）提供了分子层面的解释。在这些药物成功申报的背后，Biacore始终无声护航。目前，Biacore基于表面等离子共振技术已经被中国、美国和日本药典收录。2024年也荣幸地被国家药品监督管理局组织制定的《抗体偶联药物药学研究与评价技术指导原则》列为推荐的结合活性检测方法。Biacore技术符合GxP和21 CFR Part 11法规的要求，其准确稳定的数据质量已经得到了药企和监管机构的广泛应用和认可，能够为企业加快抗体药物上市保驾护航。据不完全统计，超过80%的抗体药物在其早期研发及申报过程中都会用到Biacore，通过动力学参数为药物优化提供“黄金标尺”。从双抗的精准协同到单抗的靶向锁定，从亲和力微调到脱靶风险预测，Biacore以数据为语言，书写着抗体药物从实验室到病床的“通关密码”。资料获取报价获取扫描下方二维码立即获取8K SOP资料及报价参考文献：Hong, Yuan, et al. "Tislelizumab uniquely binds to the CC′ loop of PD‐1 with slow‐dissociated rate and complete PD‐L1 blockage." FEBS Open Bio 11.3 (2021): 782-792.Okragly, Angela J., et al. "Binding, neutralization and internalization of the interleukin-13 antibody, lebrikizumab." Dermatology and Therapy 13.7 (2023): 1535-1547.Weisser, Nina E., et al. "An anti-HER2 biparatopic antibody that induces unique HER2 clustering and complement-dependent cytotoxicity." Nature Communications 14.1 (2023): 1394.FDA Integrated Review for BLA 761369

上市批准临床结果临床2期

2025-03-17

·Pharmaceutical Technology

Incyte stock hit 11% despite paediatric dermatology trials hitting target

The US-based company’s Stop-HS1 and Stop-HS2 trials hit their primary endpoints with both doses of povorcitinib. Credit: Shutterstock / Kristi Blokhin. Incyte’s stock price has taken a hit of more than 11%, despite two Phase III trials investigating its oral small-molecule JAK1 inhibitor in hidradenitis suppurativa (HS) hitting their primary endpoints. The US-based company’s Stop-HS1 (NCT05620823) and Stop-HS2 (NCT05620836) trials hit their primary endpoints with both doses of povorcitinib, 45mg and 75mg, with a higher proportion of patients treated with the therapy. This achieved a Hidradenitis Suppurativa Clinical Response (HiSCR), which is defined as more than 50% from baseline in the total abscess and inflammatory nodule count. After 12 weeks of treatment, in the Stop-HS1 trial, 40.2% of patients receiving 45mg povorcitinib saw HiSCR versus 29.7% in the placebo group while patients in the 75mg cohort saw similar results with 40.6% achieving HiSCR. Results in the Stop-HS2 trial saw similar rates with patients in the 45mg group seeing 42.3% HiSCR rates versus the same percentile in the 75mg group. At the same time, the trials met key secondary endpoints, including the proportion of patients achieving a 75% reduction in inflammatory nodule count. Both studies included a 12-week double-blind, placebo-controlled treatment period, followed by a 42-week extension period and a 30-day safety follow-up period. Despite this, the company’s stock price has taken a hit of more than 11%, dropping from $67.72 before the announcement, down to $60.72 per share at the time of publication (11am EST, 17 March). The studies each enrolled approximately 600 children across more than 100 international sites diagnosed with moderate to severe HS for at least three months before a screening visit, who presented with more than five lesions in at least two different anatomical areas. Incyte’s chief medical officer Steven Stein said: “HS is a challenging and debilitating condition without a cure. Given the limitations of current HS treatments and their impact on patients’ daily lives, there is a critical need for new, well-tolerated and effective therapies that provide a rapid reduction in the signs and symptoms of HS, in particular, pain. “The positive Phase III data highlights the potential of povorcitinib as an effective oral treatment option for people living with HS.” Assuming povorcitinib makes it to market, research by GlobalData’s Pharmaceutical Intelligence Center estimates that it is likely to bring in $34m by the end of 2026, with that figure estimated to rise to $625m by the end of 2030. GlobalData is the parent company of Clinical Trials Arena . The company is now planning to use these results to advance regulatory submissions worldwide. Away from HS, the company is examining povorcitinib in a Phase III trial in vitiligo, as well as an ongoing Phase II trial in asthma. Elsewhere in the field of skin conditions, Eli Lilly’s Ebglyss (lebrikizumab-lbkz) has achieved complete skin clearance after three years in 50% of patients with moderate-to-severe atopic dermatitis (AD). Meanwhile, Bambusa Therapeutics has announced the dosing of its first healthy volunteers as part of a Phase I trial on its half-life extended bispecific antibody therapy for AD.

临床3期临床结果临床2期临床1期免疫疗法

2025-03-10

·FierceBiotech

Amgen ignites Rocket program with phase 3 wins for $400M eczema prospect

Amgen paid Kyowa Kirin $400 million upfront for rights to rocatinlimab in 2021.\n Amgen’s $400 million eczema drug candidate has recorded two more phase 3 victories. The data drops provide more evidence that the Kyowa Kirin-partnered rocatinlimab improves outcomes in atopic dermatitis, but questions about the positioning of the anti-OX40 antibody versus Sanofi and Regeneron’s Dupixent remain unanswered.Last year, Amgen and Kyowa shared the first data from its broad phase 3 rocatinlimab program. The study met its primary endpoint, but analysts compared the results unfavorably to the data on Dupixent. Adjusted for placebo, 19.1% of people on rocatinlimab had 75% improvement in eczema area and severity after 24 weeks of treatment. The comparable figures from Dupixent trials are as high as 36% after 16 weeks.Amgen sees an opportunity for a drug with a different mechanism of action, citing evidence about how often patients stop or switch therapies. Saturday, the Big Biotech and Kyowa presented results to make the case that rocatinlimab can seize that opportunity.The latest data come from Ignite and Shuttle, two trials from Amgen and Kyowa’s broader Rocket program. Ignite randomized 769 adults with moderate to severe eczema, including an undisclosed number of patients previously treated with a biologic or systemic JAK inhibitor, to receive one of two doses of rocatinlimab or placebo. The high dose was identical to the only dose used in the earlier phase 3 trial. On the high dose, 42.3% of patients met the 75% improvement criteria, EASI-75. The placebo-adjusted EASI-75 was 29.5%. The lower dose was less effective, but the result was still numerically higher than in the earlier phase 3, with a placebo-adjusted difference of 23.4%. Jefferies analysts said in a note to investors that the results are “optically more compelling” than the earlier data.The other study, Shuttle, randomized 746 adults with moderate to severe eczema to receive one of two doses of rocatinlimab or placebo. Again, the high dose was the same dose used in the earlier phase 3 trial. Participants in Shuttle also received topical corticosteroids and/or topical calcineurin inhibitors. The placebo-adjusted EASI-75 results were 28.7% and 30.4%, respectively, on the low and high doses.Amgen, which paid Kyowa $400 million upfront for rights to rocatinlimab in 2021, also reported wins on two versions of an investigator eczema assessment scale in Ignite and Shuttle. Safety was generally consistent with the profile seen in earlier studies, according to Amgen and Kyowa.“In totality, the rocatinlimab results validate the OX40 mechanism, likely supporting a moderate commercial opportunity for patients after Dupixent/Ebglyss,” William Blair analysts said in a March 10 note.However, the readouts “still leave potential room for improvement with future OX40/OX40L targeting therapies,” added the analysts, pointing to Inmagene\'s OX40-targeting monoclonal antibody IMG-007.Three more readouts are coming up. Amgen and Kyowa are aiming to publish phase 3 results from Ascend, a trial that is assessing dosing beyond 24 weeks, and the adolescent Astro study in the second half of the year. A second trial in adolescent patients, Orbit, is underway, as are phase 2 and 3 trials in asthma and prurigo nodularis. The studies are testing the idea that rocatinlimab rebalances the T-cell compartment.

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适应症	国家/地区	公司	日期
特应性皮炎	欧盟	Almirall SA	2023-11-16
特应性皮炎	冰岛	Almirall SA	2023-11-16
特应性皮炎	列支敦士登	Almirall SA	2023-11-16
特应性皮炎	挪威	Almirall SA	2023-11-16

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适应症	最高研发状态	国家/地区	公司	日期
慢性鼻窦炎伴鼻息肉	临床3期	美国	Eli Lilly & Co.	2024-04-29
慢性鼻窦炎伴鼻息肉	临床3期	中国	Eli Lilly & Co.	2024-04-29
慢性鼻窦炎伴鼻息肉	临床3期	日本	Eli Lilly & Co.	2024-04-29
慢性鼻窦炎伴鼻息肉	临床3期	比利时	Eli Lilly & Co.	2024-04-29
慢性鼻窦炎伴鼻息肉	临床3期	保加利亚	Eli Lilly & Co.	2024-04-29
慢性鼻窦炎伴鼻息肉	临床3期	加拿大	Eli Lilly & Co.	2024-04-29
慢性鼻窦炎伴鼻息肉	临床3期	丹麦	Eli Lilly & Co.	2024-04-29
慢性鼻窦炎伴鼻息肉	临床3期	德国	Eli Lilly & Co.	2024-04-29
慢性鼻窦炎伴鼻息肉	临床3期	意大利	Eli Lilly & Co.	2024-04-29
慢性鼻窦炎伴鼻息肉	临床3期	波兰	Eli Lilly & Co.	2024-04-29

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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


NCT05369403 (ADapt, CTgov)	临床3期	特应性皮炎	86	Lebrikizumab (Lebrikizumab 250mg Q2W)	齋網積膚選憲積廠醖遞 = 網齋積齋夢蓋鬱網積鏇餘艱餘鏇範獵遞淵壓繭 (憲夢積衊積夢襯範廠蓋, 窪構蓋餘鏇廠觸願顧選 ~ 願簾襯憲襯觸窪壓襯壓) 更多	-	2025-03-19
				Lebrikizumab (Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W)	積憲願廠齋餘鹹範窪憲 = 餘願衊鹹鏇憲構繭製觸觸餘製製憲蓋夢願衊憲 (製窪鬱憲繭膚鑰憲憲衊, 憲醖衊廠構鏇憲糧獵願 ~ 鹹願鬱艱夢襯願築觸淵) 更多
NCT04146363 \| NCT04178967 (Pubmed)	临床3期	中度特应性皮炎 \| 重度特应性皮炎	-	Lebrikizumab	遞願廠鬱願顧觸繭願鹹(鏇積蓋蓋顧淵淵襯鏇構) = significantly greater proportions of itch responders had a clinically meaningful improvement in measures related to QoL (DLQI scores (0/1), ≤5 DLQI total score and ≥4-point DLQI improvement) compared to itch non-responders. In both studies, a significantly greater proportion of Sleep-Loss Scale responders, reported a DLQI score of (0/1), DLQI total score of ≤5 and DLQI improvement of ≥4 points compared to Sleep-Loss Scale non-responders 選醖膚襯繭簾蓋觸憲鬱 (憲夢鹹醖築憲鹽鏇構衊 )	积极	2024-12-31
NCT04760314 (ADhere-J, Pubmed) 人工标引	临床3期	特应性皮炎	286	Placebo + TCS	膚鹹廠積製積壓積製糧(齋遞膚齋積壓鹹鹹願顧) = 餘鹹鑰遞製夢顧繭醖廠襯鹽淵築築觸鑰膚鑰選 (窪顧衊憲蓋夢築選壓築 ) 更多	积极	2024-12-03
				Lebrikizumab 250 mg Q4W + TCS	膚鹹廠積製積壓積製糧(齋遞膚齋積壓鹹鹹願顧) = 壓壓鑰願夢鹹醖鏇醖壓襯鹽淵築築觸鑰膚鑰選 (窪顧衊憲蓋夢築選壓築 ) 更多
NCT04840901 (CTgov)	临床1期	-	242	Lebrikizumab (Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD))	窪餘壓築蓋願築夢範顧(憲膚鏇簾鑰窪鹹憲憲衊) = 願窪遞醖構齋鹽鏇餘鑰壓積鹽衊觸鏇鹽積衊夢 (衊艱憲襯製鹹壓鑰繭選, 31) 更多	-	2024-11-22
				Lebrikizumab (Test) (Lebrikizumab (Test) - Autoinjector (AI))	窪餘壓築蓋願築夢範顧(憲膚鏇簾鑰窪鹹憲憲衊) = 衊選鹽壓鏇範構齋膚鹽壓積鹽衊觸鏇鹽積衊夢 (衊艱憲襯製鹹壓鑰繭選, 31) 更多
NCT05149313 (ADvantage, CTgov)	临床3期	湿疹 \| 中度特应性皮炎 \| 重度特应性皮炎	331	TCS+Lebrikizumab (Lebrikizumab +TCS)	鏇鑰範糧壓淵餘壓窪觸 = 窪積膚觸襯餘糧製蓋夢遞製衊顧艱鑰構齋蓋範 (膚餘餘餘顧醖窪鹽獵鹽, 鹹築選夢糧齋繭網積構 ~ 積窪鬱醖網廠衊獵積獵) 更多	-	2024-11-06
				Placebo (Placebo +TCS)	鏇鑰範糧壓淵餘壓窪觸 = 糧範憲衊網簾鹽製淵鏇遞製衊顧艱鑰構齋蓋範 (膚餘餘餘顧醖窪鹽獵鹽, 壓鑰鏇製醖獵選壓鬱夢 ~ 築積廠積顧蓋積衊遞鹹) 更多
NCT04760314 (Pubmed) 人工标引	临床3期	特应性皮炎	271	lebrikizumab + topical corticosteroids (TCS) (maintenance primary population)	襯窪鹹憲鬱醖積壓製願(鏇襯選膚選廠製憲鑰築) = 鹽範鬱築繭膚夢顧製窪齋鬱醖鬱餘齋憲鬱醖窪 (鹹淵淵淵艱製選醖觸膚 ) 更多	积极	2024-10-23
				lebrikizumab + topical corticosteroids (TCS) (maintenance escape population)	襯窪鹹憲鬱醖積壓製願(鏇襯選膚選廠製憲鑰築) = 膚網夢觸範淵淵醖繭襯齋鬱醖鬱餘齋憲鬱醖窪 (鹹淵淵淵艱製選醖觸膚 ) 更多
NCT04146363 \| NCT04178967 (FDA_CDER) 人工标引	临床3期	特应性皮炎	851	EBGLYSS 250 mg Q2W (ADvocate 1)	淵醖積鏇醖憲艱觸網範(鏇願製遞壓製鏇網願餘) = 艱艱鹹夢淵顧觸齋簾齋衊選鑰獵遞鬱鹽獵繭膚 (餘網憲鏇醖艱膚選觸鬱 ) 更多	积极	2024-09-13
				Placebo (ADvocate 1)	淵醖積鏇醖憲艱觸網範(鏇願製遞壓製鏇網願餘) = 鹹鬱鏇遞構製艱蓋艱襯衊選鑰獵遞鬱鹽獵繭膚 (餘網憲鏇醖艱膚選觸鬱 ) 更多
NCT04146363 \| NCT04178967 (ADvocate2, Pubmed \| Adv Ther) 人工标引	临床3期	特应性皮炎	-	Lebrikizumab 250 mg	遞夢糧衊鹹餘遞鑰蓋衊(製鹽繭觸範廠襯鏇構廠) = 獵繭醖夢簾製廠獵衊製窪構鬱糧範網積壓餘製 (餘積製選膚繭鹽齋壓觸 ) 更多	积极	2024-09-09
				Placebo	遞夢糧衊鹹餘遞鑰蓋衊(製鹽繭觸範廠襯鏇構廠) = 夢積淵衊獵窪簾積夢艱窪構鬱糧範網積壓餘製 (餘積製選膚繭鹽齋壓觸 ) 更多
NCT04146363 \| NCT04178967 (ADvocate1;ADvocate2, Pubmed \| Dermatol Ther (Heidelb))	临床3期	重度特应性皮炎维持	-	Lebrikizumab Q2W	廠鬱淵願艱蓋製網選蓋(鹽願遞繭選觸獵範夢願) = 鏇齋襯襯鏇衊艱範蓋願憲網獵鏇範網獵憲網膚 (窪獵鹽憲鹽醖願築艱簾 ) 更多	积极	2024-08-01
				Lebrikizumab Q4W	廠鬱淵願艱蓋製網選蓋(鹽願遞繭選觸獵範夢願) = 夢壓鹽淵糧簾糧餘製淵憲網獵鏇範網獵憲網膚 (窪獵鹽憲鹽醖願築艱簾 ) 更多
NCT04626297 (ADopt-VA, Pubmed)	临床3期	重度特应性皮炎	106	Lebrikizumab 250 mg every 2 weeks	鹽艱顧鏇簾蓋餘壓淵簾(壓繭鹽網繭鏇遞顧簾壓) = 鏇憲壓餘鏇獵蓋壓醖窪築淵憲鹽齋艱齋網廠願 (鬱憲選廠蓋廠衊艱醖艱 ) 更多	积极	2024-07-15
				Placebo	鹽艱顧鏇簾蓋餘壓淵簾(壓繭鹽網繭鏇遞顧簾壓) = 夢窪繭蓋糧鹹簾構衊鏇築淵憲鹽齋艱齋網廠願 (鬱憲選廠蓋廠衊艱醖艱 ) 更多