Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Risankizumab is a human monoclonal antibody against IL23 p19, part of a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to its receptor. Primary non-response to risankizumab is high in both CD and UC. Currently, there are no predictors of response to risankizumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of risankizumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled risankizumab (risankizumab-800CW). This study aims to assess the safety and the optimal dose of risankizumab-800CW to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).

开始日期2024-10-01

申办/合作机构

University Medical Center Groningen

NCT06571266 / Recruiting临床1期

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes

This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.

开始日期2024-09-11

申办/合作机构

AbbVie, Inc.

NCT06548542 / Recruiting临床2期

A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.
The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide.
Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.

开始日期2024-09-04

申办/合作机构

AbbVie, Inc.

100 项与瑞莎珠单抗相关的临床结果

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100 项与瑞莎珠单抗相关的转化医学

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100 项与瑞莎珠单抗相关的专利（医药）

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512

项与瑞莎珠单抗相关的文献（医药）

2024-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Prescribing patterns and persistence of biological therapies for psoriasis management: a retrospective cohort study from Saudi Arabia

Article

作者: Fazel, Mohammad ; Alyazidi, Wejdan ; Alkaff, Tuqa ; Almalki, Ziyad ; Alomar, Mukhtar ; Almakki, Sarah ; Alamer, Ahmad ; Mobarki, Fatimah ; Aldosari, Saad ; Alahmari, Abdullah

BACKGROUND:

Biological therapies are effective for psoriasis, but patient responses vary, often requiring therapy switching or discontinuation.

OBJECTIVES:

To identify physicians' prescribing patterns of biological therapies at a referral tertiary center in Saudi Arabia and assess the probability of biologic persistence following treatment initiation.

METHODS:

We conducted a retrospective study of biologic-naïve adult psoriasis patients who initiated therapy from October 2013 to July 2022 in Dammam. Descriptive statistics and a Kaplan-Meier analysis evaluated treatment persistence at 6, 12, 24, and 36 months.

RESULTS:

A total of 151 patients received adalimumab (n = 89), etanercept (n = 17), risankizumab (n = 30), ustekinumab (n = 14), and ixekizumab (n = 1). At 6 months, all therapies demonstrated 100% persistence. At 12 months, persistence was highest for ustekinumab (100%) and lowest for etanercept (88.2%). At 24 months, ustekinumab maintained 100% persistence, followed by risankizumab (96.6%), adalimumab (94.3%), and etanercept (76.4%). At 36 months, risankizumab had the highest persistence (96.6%), followed by adalimumab (83.1%), ustekinumab (78%), and etanercept (70.6%). The most common reasons for discontinuation were lack of effectiveness and intolerability.

CONCLUSION:

This study shows changing psoriasis treatment patterns with new therapies. Risankizumab demonstrated high long-term persistence, while etanercept and ustekinumab showed declining persistence, suggesting evolving treatment considerations.

2024-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Effectiveness and safety of risankizumab in VEry severe plaque psoriasis: a real-life retrospective study (VESPA-Study)

Article

作者: Bonifati, Claudio ; Graceffa, Dario ; Orsini, Diego ; Megna, Matteo ; Cameli, Norma ; Assorgi, Chiara ; Potestio, Luca

BACKGROUND:

The recent introduction of biological drugs specifically targeting the interleukins involved in psoriasis pathogenesis revolutionized the therapeutic scenario of moderate to severe forms of psoriasis. Among these, risankizumab, an anti-IL-23, was shown to be effective both in clinical trials and real-life experiences. However, data on its use on very severe forms of psoriasis, defined by a Psoriasis Area Severity Index (PASI) of at least 30, are scant. In this context, our study aimed to investigate the outcomes of patients with very severe psoriasis, and the involvement of difficult-to-treat areas treated with risankizumab for up to 2 years.

METHODS:

A retrospective, observational study enrolled patients with very severe plaque psoriasis and the involvement of difficult-to-treat areas undergoing treatment with risankizumab. Clinical and demographic data were collected at baseline. Moreover, at baseline and each dermatological examination (16, 28, 40 and 104 weeks), clinical improvement was measured using the percentage of patients achieving PASI 75/90/100 response, site-specific Psoriasis Global Assessment and Dermatology Life Quality Index.

RESULTS:

At baseline, the mean PASI was 35.1 ± 5.1. A significant reduction was observed since week 16 and maintained up to week 104. Moreover, the Psoriasis Global Assessment and Dermatology Life Quality Index improved as well.

CONCLUSIONS:

Risankizumab showed to be effective and safe in patients affected by very severe forms of psoriasis with the involvement of difficult-to-treat areas.

2024-12-31·The Journal of dermatological treatment

Efficacy of risankizumab across subgroups in patients with active psoriatic arthritis: a post hoc integrated analysis of the phase 3 KEEPsAKE 1 and KEEPsAKE 2 randomized controlled trials

Article

作者: Kaplan, Blair ; Photowala, Huzefa ; Paek, So Yeon ; Armstrong, April ; Merola, Joseph F. ; Yue, Cuiyong ; Khattri, Saakshi ; Kristensen, Lars Erik ; Padilla, Byron

In the KEEPsAKE 1 (NCT03675308) and KEEPsAKE 2 (NCT03671148) phase 3 trials, risankizumab demonstrated greater efficacy compared with placebo in patients with active psoriatic arthritis (PsA). This post hoc integrated analysis evaluated achieving the following efficacy outcomes at weeks 24 and 52 by baseline demographics and clinical characteristics: ≥20%/50%/70% improvement in American College of Rheumatology response criteria (ACR20/50/70), ≥90% improvement in Psoriasis Area and Severity Index, minimal disease activity status, Low Disease Activity status (Disease Activity in Psoriatic Arthritis), and minimal clinically important difference in pain. Baseline demographics and clinical characteristics were similar between risankizumab (n = 707) and placebo (n = 700) groups. Numerically higher ACR20 response rates at week 24 (primary endpoint) were observed among the risankizumab (46.3%-60.1%) vs. placebo (15.5%-36.2%) cohorts, regardless of subgroups. At week 52, consistent proportions of patients randomized to risankizumab achieved ACR20 (48.6%-75.8%) while those initially randomized to placebo and switched to risankizumab experienced an improvement from week 24 (43.7%-63.9%), regardless of subgroups. Similar trends were observed for other efficacy measures assessing rigorous skin response criteria, composite measures of overall disease activity, and PsA-related symptoms. Risankizumab treatment was efficacious among patients with varying demographic and psoriatic disease characteristics through 52 weeks.

550

项与瑞莎珠单抗相关的新闻（医药）

2024-09-29

·药精通Bio

自免“不觉晓”，靶点知多少？

OTC2024类器官前沿应用与3D细胞培养论坛圆满落幕，点击图片可查看会后报告，咨询OTC2025类器官论坛请联系：王晨 180 1628 8769 随着对自免发病机制的了解，靶向炎性细胞因子、免疫细胞和细胞内激酶的生物药和小分子抑制剂已成为治疗自免疾病的标准手段，也成了创新药竞相争夺的一块肥肉！图注：部分已上市产品的获批适应症布局（人工整理，累惨本猫，或有偏颇，持续修订）今天我们聊一聊自免领域能够成药的靶点，都有哪些？ 01 细胞因子 1.1 TNF TNF是一种主要由髓系细胞和活化T细胞分泌促炎细胞因子，和多种自免疾病的发病有关。阻断TNF通路可以对多种自免疾病起到治疗作用，包括，类风关（RA）RA、幼年特发性关节炎（JIA）、强直性脊柱炎（AS）、银屑病和银屑病关节炎（PsA）等。而这个靶点也造就了曾经的全球“药王”阿达木单抗！除此外还有多款该靶点药物获得FDA批准，相关药物以及批准适应症情况如下表： 1.2 IL-17 IL-17A，通常称为IL-17，是Th17细胞亚群的标志性细胞因子，关于靶点的基本介绍在我们之前的文章也有写过（在文后有统一的合集，欢迎感兴趣的读者查看）。来自动物和临床研究的证据表明，IL-23/IL-17轴是多种自身免疫性疾病（如AS、PsA和RA）的治疗靶标。目前靶向IL-17药物包括，IL-17A（苏金单抗和依奇珠单抗）和IL-17RA（Brodalumab）等。 1.3 IL-23 IL-23作为IL-12家族的一员，是一种由DC和活化的巨噬细胞分泌的促炎细胞因子。IL-23和IL-12共用p40 亚基，但IL-23更广泛地参与自身免疫性疾病的发病机制。通过靶向IL-12/IL-23p40或IL-23p19，可以阻断IL-23信号。IL-23的阻断可有效治疗银屑病和PsA。从目前上市的药物看，靶向IL-12/IL-23p40抗体药物为乌司奴单抗，可阻断IL-12和IL-23；靶向IL-23p19的药物包括：Guselkumab、Tildrakizumab、Risankizumab和Mirikizumab，这些药物仅抑制IL-23。 1.4 IL-1 IL-1家族包括IL-1α和IL-1β，是和先天免疫反应密切相关的促炎细胞因子。IL-1和受体的结合，需要IL-1R1与IL-1R3形成异源三聚体，随后募集髓MYD88，并触发随后的激酶级联反应，从而促进炎症反应。目前研究认为在自免中IL-1β比IL-1α更重要。靶向IL-1的药物已有3种被批准：Canakinumab和Gevokizumab，这两种抗体药均靶向IL-1β；Anakinra，重组IL-1受体拮抗剂；Rilonacept，IL-1R1-Fc融合蛋白。抗IL-1疗法更广泛地用于自身炎症性疾病，如全身性 JIA、AOSD和 CAPS。其他具有高炎症负荷的疾病，如痛风和复发性心包炎，也可通过 IL-1 靶向治疗进行控制。另外，由于IL-1在炎症性疾病中的广泛作用，IL-1阻断有望在治疗顽固性自身免疫性疾病（包括SLE和系统性硬化症）及控制过度的促炎反应（如细胞因子释放综合征和巨噬细胞活化综合征）方面提供临床益处。 1.5 IL-6 IL-6是一种多效细胞因子，由各种类型细胞在感染、炎症和恶性肿瘤的情况下产生。 IL-6在生理和病理条件下具有多种生物学功能。生理状态下，IL-6负责巨噬细胞分化为M2状态，通过成骨细胞RANK配体表达的增加进行破骨细胞生成，及通过肝脏中的JAK-STAT通路进行急性期反应。病理（炎症）条件下，IL-6 通过调节FOXP3、RORC和IL-23R表达，参与Th17分化，同时IL-6对滤泡辅助性T细胞的发育和B细胞的成熟也很重要。阻断IL6通路可以通过靶向IL-6、IL-6R、gp130、JAK和STAT3来实现。这其中由于副作用，gp130和STAT3无法成药。目前抗IL-6抗体、抗IL-6R抗体和JAK抑制剂已被批准用于自免疾病的治疗。经典的IL-6抗体药物托珠单抗，目前被批准用于治疗RA、JIA、AOSD、巨细胞动脉炎和细胞因子释放综合征。 1.6 I型IFN I型IFN，包括IFN-α、IFN-β、IFN-ε、IFN-κ和IFN-ω。研究表明，IFN-α在自身免疫性疾病，尤其是SLE的发病机制中起着至关重要的作用，IFN-α以外的IFN 的作用尚不清楚。在SLE中，IFN-α通过刺激髓系DC、Th1细胞和B细胞及抑制Treg细胞来促进促炎反应，使用重组IFN-α治疗后产生的SLE样综合征的发展也表明 1 型IFN 在自身免疫性疾病中的病理作用。 IFN-α在SLE中的病理生理学意义,使得导致了I型IFN靶向免疫治疗的发展。Rontalizumab和Sifalimumab是靶向IFN-α的抗体，但在SLE中未能控制疾病活动。 02 靶向B细胞随着对B细胞功能的研究，B细胞被认为是自身免疫性疾病的积极参与者。B细胞耗竭疗法在RA和多发性硬化症（MS）中的成功也证明了B细胞在自免中的病理意义。除了在抗体产生中发挥作用外，B细胞还通过抗原呈递、三级淋巴组织的形成和细胞因子（如IL-6、TNF、IFN-γ和GM-CSF）的产生参与到自身免疫中。 2.1 CD20 CD20仅在pro-B细胞到记忆B细胞谱系中表达，不在浆细胞中表达。过去几十年，抗CD20疗法一直是B细胞耗竭的主要工具。利妥昔单抗是一种靶向CD20的嵌合抗体，可有效消除 CD20+ B细胞，耗尽分泌自身抗体的浆母细胞的细胞来源，并阻止不依赖抗体的B细胞功能，从而减轻自身免疫性炎症，已经在RA和MS中获得临床试验的成功。除利妥昔单抗外，多种具有不同结合表位、不同给药途径和效果的抗CD20药物在开发中。其中Ocrelizumab和Ofatumumab是人源化抗CD20 抗体，已被批准用于复发性MS。 2.2 CD19 CD19在CD20+ B 细胞以及 CD20- 浆母细胞和一些浆细胞上表达，可以起到针对抗 CD20 治疗耐药的B 细胞耗竭作用。人源化抗CD19抗体Inebilizumab已经被批准用于治疗视神经脊髓炎谱系疾病，并且正在进行临床试验以治疗其他炎症性神经系统疾病。 2.3 B细胞活化靶点抑制B细胞的另一种方法是阻断与B 细胞成熟和存活密切相关的因子这包括：BAFF受体（BAFF-R），在除浆细胞外的大多数B 细胞亚群上表达；B细胞成熟抗原（BCMA），在浆母细胞和浆细胞上表达。贝利尤单抗是一种人源化抗BAFF抗体药物，是FDA批准的用于SLE的第一个靶向免疫疗法。然而，贝利尤单抗并不对所有SLE患者具有疗效。Ianalumab是一种抗BAFF-R的单克隆抗体，在原发性干燥综合征（pSS）患者的II期试验中显示出有希望的结果。 Telitacicept是一种TACI-Ig融合蛋白，基于其对BAFF/APRIL系统的抑制作用，也正在临床开发中。 03 靶向T细胞作为适应性免疫的关键参与者，T细胞在自身免疫的发生和发展中起着关键作用。因此靶向T细胞也是自免靶向药物开发的重要考量因素。 3.1 CD28 CD28信号通过激活MAPK、AKT和NF-κB通路激活T细胞。 CTLA-4是CD28的负反馈调节因子通过占据 CD80 和CD86 来抑制 CD28 信号传导。基于CTLA-4的负向调节，设计了CTLA4 胞外结构域和IgG Fc 区（阿巴西普，CTLA4-Ig）组成的融合蛋白，目前阿巴西普已经被批准用于治疗RA 和 JIA，已证实对控制炎症性关节炎有效。其它类似药物还包括Belatacept 和MEDI5256，正处于临床研究阶段。 3.2 CD40 CD40通路是T细胞的主要激活信号，与CD40L连接后，上调CD80和 CD86 表达。活化T 细胞的CD40L与靶细胞CD40结合时，多个激酶级联反应会激活转录因子，如NF-κB和AP1，以诱导细胞存活、增殖和分化。 CD40信号转导对于参与T 细胞依赖的抗体产生、生发中心形成和记忆 B 细胞分化的B 细胞-T 细胞相互作用尤为重要。由于其在 B 细胞功能中的关键作用，靶向CD40 信号转导的治疗潜力已在临床前和临床研究中得到研究。Iscalimab（一种人源化抗 CD40 mAb）最近的II 期试验显示pSS 患者的临床改善，随后的 III 期试验正在进行中。 3.3 其它靶向其他共刺激信号转导的免疫疗法，如ICOS和OX40 通路，也正在开发中，以抑制自身免疫性疾病中的 T 细胞效应功能。作为在活化的CD4+ T 细胞上表达的共刺激分子，ICOS和OX40参与T细胞的存活、分化和活化。 04 激酶靶向治疗 JAK家族由JAK1、JAK2、JAK3和TYK2组成，与细胞因子受体（包括IL-2R、IL-4R、IL-5R、IL-6R、IL-13R 和1型IFN）、生长激素和促红细胞生成素有关。由于JAK在细胞因子通路的关键作用，JAK抑制剂已经被批准用于RA、PsA和溃疡性结肠炎。除JAK抑制剂外，布鲁顿酪氨酸激酶（BTK）抑制剂也有望通过调节 B 细胞功能来改善自身免疫性炎症。目前正在研究 BTK 抑制剂在各种自身免疫性疾病中的应用，包括 RA、MS、pSS 和SLE。 05 结论过去几十年，靶向免疫药物的进步彻底改变了自免疾病患者的治疗和临床结果。目前的靶向免疫疗法通过阻断炎性细胞因子、细胞表面分子和细胞内激酶来抑制主要的促炎信号通路。尽管靶向治疗在自身免疫性疾病中取得了巨大成功，但在药物疗效和长期安全性方面仍未满足医疗需求。除了阻断炎症通路外，未来的疗法还旨在诱导长期的免疫耐受，同时保持保护性免疫功能。希望生物技术的进步和疾病知识将为开发具有更高治疗效果和最小不良反应的新药提供机会。 END 免责声明：本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。 OTC2024类器官前沿应用与3D细胞培养论坛圆满落幕，点击图片可查看会后报告，咨询OTC2025类器官论坛请联系：王晨 180 1628 8769

申请上市上市批准

2024-09-28

·生物制品圈

信达生物IL-23单抗上市申请获CDE受理

9月26日，CDE官网显示，信达生物自主研发的IL-23p19抗体注射液匹康奇拜单抗（IBI112）上市申请获受理。 CDE官网匹康奇拜单抗（IBI112）为重组抗白介素23p19亚基（IL-23p19）抗体注射液，是由信达生物自主研发，具有自主知识产权的一种单克隆抗体，特异性结合IL-23p19亚基。通过阻止IL-23与细胞表面受体结合，阻断IL-23受体介导信号通路发挥抗炎作用。该药物是首款递交上市申请的由中国企业自主研发的IL-23p19靶向药物。就在今年5月，信达生物宣布匹康奇拜单抗在中国中重度斑块状银屑病受试者中开展的3期临床研究（CLEAR-1）中达成主要终点和所有关键次要终点。 CLEAR-1（NCT05645627）是一项在中重度斑块型银屑病受试者中评估匹康奇拜单抗有效性和安全性的多中心、随机、双盲、安慰剂对照的Ⅲ期临床研究。研究共纳入500例受试者，按1:2:2的比例随机接受安慰剂、匹康奇拜单抗 200 mg（0，4，8周3次给药）后，在20周开始接受200mg 或者100mg 每12周一次给药的长期维持。研究设置双主要终点，分别为第16周时达到银屑病面积和严重程度指数（PASI）改善≥90%（PASI 90）的受试者比例，和第16周时达到静态医师总体评分（sPGA）清洁（0分）或接近清洁（1分）的受试者比例。结果显示：在第16周，接受匹康奇拜单抗治疗的群体中，达到PASI 90标准和sPGA评分为0或1的参与者比例分别高达80.3%和93.5%，这两项指标均显著超越了对照组的数据（PASI 90: 2.0%，sPGA 0/1: 13.1%；P值均小于0.0001）。这也是本靶点全球唯一一个首要研究终点（16周PASI 90）突破80%的银屑病III期注册临床研究。治疗持续至第52周时，匹康奇拜单抗在两个不同剂量的组别中，参与者达到PASI 90和sPGA 0/1评分的比例保持不变；具体到第52周，200 mg剂量组的PASI 90和sPGA 0/1评分分别保持在84.9%和85.9%。所有关键的次要研究目标均已实现，包括在第16周时PASI评分改善至少75%（PASI 75）、PASI评分改善达到100%（PASI 100）、sPGA评分达到0分以及DLQI评分为0或1分的参与者比例；匹康奇拜单抗在这些指标上的表现均明显优于安慰剂组，并且这种优势基本保持到了第52周。整体来看，该药物的安全性表现良好，与以往的临床研究相比，没有发现新的安全隐患。此外，相对于目前主流上市药物每年7~16次的给药频率，匹康奇拜单抗年度给药次数预计仅需5-6次，维持期能实现季度给药，展现出兼顾疗效、安全性与更友好治疗方案的优势。 IL-23靶点竞争格局 IL-23属于仅包含异二聚体的特殊IL-12家族，由2个蛋白亚基p19和p40通过二硫键连接。IL-23被细胞膜上的异二聚体受体蛋白复合物所识别，该受体复合物由IL-23R及IL-12β组成，分别与p19和p40亚基结合。 IL-23作用机制 IL-23在先天免疫和适应性免疫之间起着关键的连接作用，对早期局部免疫反应的激活至关重要。它主要促进了干扰素-γ（IFN-γ）的产生，这种细胞因子在Th1细胞反应和细胞介导的免疫应答中扮演着核心角色。此外，IL-23还主导着自然杀伤（NK）细胞的激活，增强T细胞的增殖，并在调节抗体的产生中发挥作用。临床研究的大量数据表明，IL-23在多种自身免疫疾病中的水平升高，这些疾病包括但不限于银屑病、炎症性肠病（IBD）、类风湿性关节炎（RA）以及多发性硬化症（MS）。这些发现强调了IL-23作为治疗这些疾病的潜在靶点的重要性。因此IL-23逐渐成为治疗多种自身免疫性疾病的重要靶点之一。 IL-23靶点药物在药物开发市场，IL-23靶点的药物竞争情况激烈，已上市的四个IL-23p19按上市时间排序分别是古塞奇尤单抗（强生）、替瑞奇珠单抗（康哲）、利生奇珠单抗（艾伯维）和mirikizumab（礼来）。除此之外，还有大量管线处在临床开发阶段。为促进抗体行业的交流与创新，2024年10月16-17日第七届金秋十月抗体产业发展大会如约而至。会议旨在为研究人员提供一个互动交流的平台，有助于推动抗体产业的进一步发展。会议内容时间：2024年10月16-17日地点：上海张江（酒店定向通知）规模：600-800人主办单位：生物制品圈、抗体圈演讲支持：Entegris、瑞孚迪、AS ONE CORPORATION 会议费用：免费FREE!（仅收取100元报名定金，含参会学习、茶歇、会议手册，定金概不退还），先到先得，报完即止！报名方式：扫描下方二维码或点击文章最底部“阅读原文”→ 填写表格 → 报名成功（报名志愿者，承担一定工作，请慎重考虑，免交定金）！组委会获得报名信息后，根据报名信息进行初筛，并进一步与报名者沟通确认，实现精准邀请。最终有机会进入大会微信群（严格审核通过）。日程安排更多嘉宾正在邀请中资料来源 1.CDE官网 2.信达生物官网 3.IL-23 past, present, and future: a roadmap to advancing IL-23 science and therapy 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床3期申请上市临床结果

2024-09-25

·PipelineReview

Oruka Therapeutics Announces Preclinical Data for ORKA-001 at the European Academy of Dermatology and Venereology Congress

Half-life in non-human primates (NHP) of 30.3 days after subcutaneous (SQ) administration and 33.8 days after intravenous (IV) administration Equivalent potency to risankizumab with similar binding affinity and epitope demonstrated in several preclinical assays MENLO PARK, CA, USA I September 25, 2024 I Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today announced new preclinical data on ORKA-001, a novel extended half-life monoclonal antibody targeting IL-23p19, from its presentation at the European Academy of Dermatology and Venereology Congress (EADV). “This new data gives us additional confidence that ORKA-001 can achieve our base-case expectation of dosing once every six months and further reason to believe that we could reach once-yearly dosing with the potential for higher efficacy,” said Lawrence Klein, Oruka’s Chief Executive Officer. “Our goal is to offer people with psoriasis the most possible freedom from their condition, and we think ORKA-001 is showing tremendous potential to achieve that.” About ORKA-001 ORKA-001 is a novel, subcutaneously (SQ) administered, half-life extended monoclonal antibody targeting IL-23p19. Inhibitors of IL-23p19 have become the preferred first-line therapy for patients with moderate-to-severe PsO given their strong efficacy and safety profile. Currently approved therapies are dosed four to six times per year and deliver PASI 100, or fully clear skin, for less than half of patients after four months. ORKA-001 has the potential to be dosed just once or twice a year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance. Data from studies in non-human primates and other preclinical assays show that ORKA-001 binds to a similar epitope with similar affinity as risankizumab and has a significantly extended half-life over three times longer than risankizumab. About Oruka Therapeutics Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. SOURCE: Oruka Therapeutics

免疫疗法

100 项与瑞莎珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	瑞莎珠单抗	L04AC18	DB14762

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
活动性中度溃疡性结肠炎	欧盟	AbbVie Deutschland GmbH & Co. KG	2024-07-26
活动性中度溃疡性结肠炎	冰岛	AbbVie Deutschland GmbH & Co. KG	2024-07-26
活动性中度溃疡性结肠炎	列支敦士登	AbbVie Deutschland GmbH & Co. KG	2024-07-26
活动性中度溃疡性结肠炎	挪威	AbbVie Deutschland GmbH & Co. KG	2024-07-26
活动性重度溃疡性结肠炎	欧盟	AbbVie Deutschland GmbH & Co. KG	2024-07-26
活动性重度溃疡性结肠炎	冰岛	AbbVie Deutschland GmbH & Co. KG	2024-07-26
活动性重度溃疡性结肠炎	列支敦士登	AbbVie Deutschland GmbH & Co. KG	2024-07-26
活动性重度溃疡性结肠炎	挪威	AbbVie Deutschland GmbH & Co. KG	2024-07-26
溃疡性结肠炎	美国	AbbVie, Inc.	2024-06-18
克罗恩病	美国	AbbVie, Inc.	2022-06-16
掌跖脓疱病	韩国	AbbVie Ltd. (South Korea)	2019-12-03
斑块状银屑病	加拿大	AbbVie, Inc.	2019-04-17
银屑病关节炎	日本	AbbVie, Inc.	2019-03-26
红皮病性银屑病	日本	AbbVie, Inc.	2019-03-26
寻常性银屑病	日本	AbbVie, Inc.	2019-03-26
脓疱型银屑病	日本	AbbVie, Inc.	2019-03-26

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
幼年特发性关节炎	临床3期	美国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	澳大利亚	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	加拿大	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	法国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	德国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	意大利	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	波兰	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	西班牙	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	英国	AbbVie, Inc.	2024-07-08
掌跖角化病	临床3期	美国	AbbVie, Inc.	2021-02-26

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临床结果

适应症

分期

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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


NCT03398148 (INSPIRE, PRNewswire) 人工标引	临床3期	活动性中度溃疡性结肠炎 \| 重度慢性溃疡性结肠炎诱导	-	SKYRIZI® (risankizumab) 1,200 mg IV	廠構簾選選網繭鹽夢築(製夢選鹽膚糧遞壓齋繭) = 醖鏇製蓋膚觸積簾鹽鏇積鏇膚網鏇醖鹽壓築積 (鏇醖膚鹹醖觸膚範鹹觸 ) 达到更多	积极	2024-07-26
				Placebo	廠構簾選選網繭鹽夢築(製夢選鹽膚糧遞壓齋繭) = 顧壓襯衊鑰簾鏇選積廠積鏇膚網鏇醖鹽壓築積 (鏇醖膚鹹醖觸膚範鹹觸 ) 达到更多
NCT03398135 (COMMAND, PRNewswire) 人工标引	临床3期	活动性中度溃疡性结肠炎 \| 活动性重度溃疡性结肠炎维持	-	risankizumab 180 mg	顧夢網糧齋膚選觸願範(構艱醖糧壓襯窪衊觸繭) = 鹹選衊獵壓壓選遞鬱艱衊襯糧鑰鑰積鬱範積鏇 (網淵淵壓範鬱窪糧選餘 ) 达到更多	积极	2024-07-26
				risankizumab 360 mg	顧夢網糧齋膚選觸願範(構艱醖糧壓襯窪衊觸繭) = 鏇齋繭觸遞鬱製夢衊顧衊襯糧鑰鑰積鬱範積鏇 (網淵淵壓範鬱窪糧選餘 ) 达到更多
NCT03398148 \| NCT03398135 (Pubmed) 人工标引	临床3期	溃疡性结肠炎维持 \| 诱导	975	Risankizumab 1200 mg (induction trial)	鏇築獵窪餘鏇鏇鏇齋鏇(糧壓淵襯壓鹽鬱觸鹽願) = 夢艱膚齋繭餘顧鹹顧鏇獵齋齋糧選衊製獵遞鑰 (醖繭廠餘鏇衊廠廠廠膚 )	积极	2024-07-22
				Placebo (induction trial)	鏇築獵窪餘鏇鏇鏇齋鏇(糧壓淵襯壓鹽鬱觸鹽願) = 繭蓋蓋鑰繭鬱願壓醖網獵齋齋糧選衊製獵遞鑰 (醖繭廠餘鏇衊廠廠廠膚 )
NCT04524611 (phase 3b, Pubmed)	临床3期	克罗恩病 anti-tumor necrosis factor (TNF) therapy	255	Risankizumab	觸艱願壓網憲夢膚蓋糧(築襯築夢醖蓋艱襯網衊) = 窪鏇顧願鹹壓鏇鬱衊衊顧壓願艱願觸顧簾範構 (範積築膚鹽鏇製製構醖, 6.6 ~ 30.3)	积极	2024-07-18
				Ustekinumab	觸艱願壓網憲夢膚蓋糧(築襯築夢醖蓋艱襯網衊) = 鬱憲觸鹹鏇艱觸製艱獵顧壓願艱願觸顧簾範構 (範積築膚鹽鏇製製構醖 )
NCT04524611 (Literature) 人工标引	临床3期	克罗恩病	423	Risankizumab	願夢憲鹹顧網獵醖鏇襯(衊糧觸繭鬱衊壓齋簾蓋) = 壓艱鹽鏇齋齋鏇鬱廠膚膚壓築鹹製積積憲網淵 (鬱糧蓋醖夢衊簾醖製衊 ) 达到更多	非劣	2024-07-17
				Ustekinumab	願夢憲鹹顧網獵醖鏇襯(衊糧觸繭鬱衊壓齋簾蓋) = 壓網築願網廠襯遞襯網膚壓築鹹製積積憲網淵 (鬱糧蓋醖夢衊簾醖製衊 ) 达到更多
NCT04713592 (IMMprint, CTgov)	临床3期	掌跖角化病 \| 斑块状银屑病	174	Placebo for Risankizumab+Risankizumab (Placebo)	廠構鹹憲憲窪齋構獵鬱(簾鏇餘淵餘簾鹽襯繭糧) = 淵壓鏇鬱製簾餘淵壓鏇範鹽膚選膚壓繭鹽齋夢 (蓋構糧顧築壓網獵觸鬱, 醖衊壓鹽窪鏇獵簾積醖 ~ 廠構範遞憲餘衊齋鬱壓) 更多	-	2024-06-14
				Risankizumab (Risankizumab)	廠構鹹憲憲窪齋構獵鬱(簾鏇餘淵餘簾鹽襯繭糧) = 齋積窪鏇餘餘鹽齋糧願範鹽膚選膚壓繭鹽齋夢 (蓋構糧顧築壓網獵觸鬱, 築觸衊襯顧鏇願夢壓窪 ~ 醖構衊鑰壓製窪膚築餘) 更多
EULAR2024 人工标引	N/A	银屑病关节炎	44	Risankizumab	願襯憲憲衊膚餘憲鑰襯(醖獵糧廠顧衊鹹醖鏇衊) = 繭廠餘膚廠壓繭襯構繭夢齋遞築構壓蓋蓋壓廠 (築鏇夢簾觸築鏇願蓋夢 ) 更多	积极	2024-06-05
NCT03671148 \| NCT03675308 (KEEPsAKE 1 and KEEPsAKE 2, Pubmed)	临床3期	银屑病关节炎 Leeds Enthesitis Index \| Leeds Dactylitis Index	1,407	Risankizumab	艱膚製蓋顧獵繭蓋餘鏇(餘襯糧簾繭艱願齋壓遞) = 願襯觸憲鹹獵構膚鏇顧觸鹹餘醖鑰鹹憲醖壓鏇 (範餘艱衊鏇願糧膚鹹衊 ) 更多	积极	2024-06-01
NCT04908475 (IMMpulse, CTgov)	临床4期	斑块状银屑病	352	Apremilast (Period A: APR)	齋遞艱齋鑰膚憲鬱襯鹽(壓範鏇繭製願醖鏇製窪) = 繭顧膚構觸築鏇淵鏇窪夢願築鏇艱鏇齋選淵網 (構網壓鹽壓壓襯積鑰蓋, 顧構選齋窪淵鬱衊衊範 ~ 夢鏇觸淵選壓獵醖艱願) 更多	-	2024-04-30
				Risankizumab (Period A: RZB)	齋遞艱齋鑰膚憲鬱襯鹽(壓範鏇繭製願醖鏇製窪) = 夢範膚遞簾醖餘衊製餘夢願築鏇艱鏇齋選淵網 (構網壓鹽壓壓襯積鑰蓋, 積淵糧醖鑰築鑰鬱餘艱 ~ 夢衊襯遞簾選選齋醖築) 更多
NCT03675308 (KEEPsAKE 1, Pubmed) 人工标引	临床3期	银屑病关节炎	828	Risankizumab 150 mg	簾夢壓鑰範遞艱餘餘製(構壓蓋廠選顧鏇艱糧願) = 淵簾築鏇積鹽窪願範鏇鑰積網蓋願鑰膚遞廠衊 (壓夢襯製醖衊糧夢衊齋 ) 更多	积极	2024-03-18