A Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of 2 Doses of Remibrutinib Over a 68-week Treatment Period in Adult Patients With Moderate to Severe Hidradenitis Suppurativa

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).

开始日期2025-03-12

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT06799000

/ Recruiting临床3期

开始日期2025-01-31

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT06744920

/ Not yet recruiting临床3期

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Remibrutinib in Patients With Generalized Myasthenia Gravis, Followed by an Open-label Extension Phase

A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment.

开始日期2024-12-23

申办/合作机构

Novartis Pharmaceuticals Corp.

100 项与 Remibrutinib 相关的临床结果

登录后查看更多信息

100 项与 Remibrutinib 相关的转化医学

登录后查看更多信息

100 项与 Remibrutinib 相关的专利（医药）

登录后查看更多信息

项与 Remibrutinib 相关的文献（医药）

2024-07-01·Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology

Bruton's tyrosine kinase inhibition for the treatment of allergic disorders

Review

作者: Suresh, Ragha V ; Dispenza, Melanie C ; Lin, Erica V

IgE signaling through its high-affinity receptor FcεRI is central to the pathogenesis of numerous allergic disorders. Oral inhibitors of Bruton's tyrosine kinase (BTKis), which are currently Food and Drug Administration-approved for treating B cell malignancies, broadly inhibit the FcεRI pathway in human mast cells and basophils, and therefore may be effective allergen-independent therapies for a variety of allergic diseases. The application of these drugs to the allergy space was previously limited by the low kinase selectivity and subsequent toxicities of early-generation compounds. Fortunately, next-generation, highly selective BTKis in clinical development appear to have more favorable risk-benefit profiles, and their likelihood of being Food and Drug Administration-approved for an allergy indication is increasing. Recent clinical trials have indicated the remarkable and rapid efficacy of the second-generation BTKi acalabrutinib in preventing clinical reactivity to peanut ingestion in adults with peanut allergy. In addition, next-generation BTKis including remibrutinib effectively reduce disease activity in patients with antihistamine-refractory chronic spontaneous urticaria. Finally, several BTKis are currently under investigation in early clinical trials for atopic dermatitis and asthma. In this review, we summarize recent data supporting the use of these drugs as novel therapies in food allergy, anaphylaxis, urticaria, and other allergic disorders. We also discuss safety data derived from trials using both short-term and chronic dosing of BTKis.

2024-05-01·The Journal of allergy and clinical immunology

BTK signaling—a crucial link in the pathophysiology of chronic spontaneous urticaria

Review

作者: Maurer, Marcus ; Saini, Sarbjit S ; Bernstein, Jonathan A

Chronic spontaneous urticaria (CSU) is an inflammatory skin disorder that manifests with itchy wheals, angioedema, or both for more than 6 weeks. Mast cells and basophils are the key pathogenic drivers of CSU; their activation results in histamine and cytokine release with subsequent dermal inflammation. Two overlapping mechanisms of mast cell and basophil activation have been proposed in CSU: type I autoimmunity, also called autoallergy, which is mediated via IgE against various autoallergens, and type IIb autoimmunity, which is mediated predominantly via IgG directed against the IgE receptor FcεRI or FcεRI-bound IgE. Both mechanisms involve cross-linking of FcεRI and activation of downstream signaling pathways, and they may co-occur in the same patient. In addition, B-cell receptor signaling has been postulated to play a key role in CSU by generating autoreactive B cells and autoantibody production. A cornerstone of FcεRI and B-cell receptor signaling is Bruton tyrosine kinase (BTK), making BTK inhibition a clear therapeutic target in CSU. The potential application of early-generation BTK inhibitors, including ibrutinib, in allergic and autoimmune diseases is limited owing to their unfavorable benefit-risk profile. However, novel BTK inhibitors with improved selectivity and safety profiles have been developed and are under clinical investigation in autoimmune diseases, including CSU. In phase 2 trials, the BTK inhibitors remibrutinib and fenebrutinib have demonstrated rapid and sustained improvements in CSU disease activity. With phase 3 studies of remibrutinib ongoing, it is hoped that BTK inhibitors will present an effective, well-tolerated option for patients with antihistamine-refractory CSU, a phenotype that presents a considerable clinical challenge.

2024-03-01·Annals of the rheumatic diseases

Efficacy and safety of remibrutinib, a selective potent oral BTK inhibitor, in Sjögren’s syndrome: results from a randomised, double-blind, placebo-controlled phase 2 trial

Article

作者: Cenni, Bruno ; Kaul, Martin ; Hanser, Malika ; Papas, Athena S ; Grioni, Andrea ; Gergely, Peter ; Tseng, Jui-Cheng ; Hillenbrand, Rainer ; Pylvaenaeinen, Ilona ; Szántó, Antónia ; Abdallah, Nasri ; Ferrero, Enrico ; Avrameas, Alexandre ; Siegel, Richard M ; Dörner, Thomas ; Santos Da Costa, Aida

Objectives:

To evaluate the safety and efficacy of remibrutinib in patients with moderate-to-severe Sjögren’s syndrome (SjS) in a phase 2 randomised, double-blind trial (NCT04035668; LOUiSSE (LOU064 in Sjögren’s Syndrome) study).

Methods:

Eligible patients fulfilling 2016 American College of Rheumatology/European League Against Rheumatism (EULAR) criteria for SjS, positive for anti-Ro/Sjögren’s syndrome-related antigen A antibodies, with moderate-to-severe disease activity (EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) (based on weighted score) ≥ 5, EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) ≥ 5) received remibrutinib (100 mg) either one or two times a day, or placebo for the 24-week study treatment period. The primary endpoint was change from baseline in ESSDAI at week 24. Key secondary endpoints included change from baseline in ESSDAI over time, change from baseline in ESSPRI over time and safety of remibrutinib in SjS. Key exploratory endpoints included changes to the salivary flow rate, soluble biomarkers, blood transcriptomic and serum proteomic profiles.

Results:

Remibrutinib significantly improved ESSDAI score in patients with SjS over 24 weeks compared with placebo (ΔESSDAI −2.86, p=0.003). No treatment effect was observed in ESSPRI score (ΔESSPRI 0.17, p=0.663). There was a trend towards improvement of unstimulated salivary flow with remibrutinib compared with placebo over 24 weeks. Remibrutinib had a favourable safety profile in patients with SjS over 24 weeks. Remibrutinib induced significant changes in gene expression in blood, and serum protein abundance compared with placebo.

Conclusions:

These data show preliminary efficacy and favourable safety of remibrutinib in a phase 2 trial for SjS.

项与 Remibrutinib 相关的新闻（医药）

2025-02-23

·医药笔记

诺华：BTK抑制剂Remibrutinib启动化脓性汗腺炎关键三期临床

▎Armstrong 2025年2月21日，诺华在Clinicaltrials.gov网站上注册了BTK抑制剂Remibrutinib治疗成人中至重度化脓性汗腺炎的三期临床试验。该三期临床试验计划入组555例中至重度化脓性汗腺炎成人患者，预计2028年完成。 Remibrutinib去年宣布在荨麻疹三期临床获得陈公公，预计今年上半年递交上市申请。适应症扩展方面，除了化脓性汗腺炎，诺华还将在今年启动全身型重症肌无力的关键三期临床试验。诺华预计2026年递交Remibrutinib治疗CINDU的上市申请，2027年递交治疗多发性硬化症的上市申请，2028年以后递交重症肌无力的上市申请。总结除了诺华，赛诺菲也重点布局BTK抑制剂在自免领域的拓展，同时开发2款BTK抑制剂。国内方面，百济神州的泽布替尼在推进膜性肾病的三期临床，诺诚健华的奥布替尼在推进多发性硬化、ITP、狼疮、NMOSD等多项自免适应症的临床试验。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

临床3期引进/卖出抗体药物偶联物临床2期

2025-01-14

·Pharmaceutical Technology

JP Morgan 2025: Novartis streamlines its portfolio to drive future growth

Vas Narasimhan, chief executive officer of Novartis AG, speaks during a news conference in Tokyo, Japan. At the JP Morgan Healthcare Conference 2025, Narsimhan talked about how Novartis is optimistic its streamlined portfolio will fuel high growth in the next five years and into the 2030. Photographer: Akio Kon/Bloomberg via Getty Images Positioning itself as a pure-play innovative medicines company, Novartis is bullish about the growth towards 2030 by placing an emphasis on a streamlined portfolio to drive sales, says CEO Vas Narasimhan. Novartis CEO Vas Narasimhan outlined projections for the company’s future at the 2025 JP Morgan Healthcare conference in San Francisco on 14 January. Novartis, he said, expects peak sales of over $3bn for its eight leading branded products which, along with promising growth in China and Japan, which will fuel the company’s revenues throughout the next decade. Chief among these drugs are Cosentyx (secukinumab) and Kisqali (ribociclib succinate), each projected by Novartis to generate peak sales of over $8bn. Alongside these, the company identified four drugs in clinical development, which it expects to drive growth in the 2030s; remibrutinib, OAV101 IT, and ianalumab, all in Phase III trials, and pelacarsen, currently in a Phase II trial (NCT04023552) for aortic valve stenosis. Narasimhan said Novartis expects 15 submission-enabling data readouts in the next two years from their core assets, which will maintain profits in the face of patent expiries for their current blockbuster drugs. Patent expiries of major drugs have been a key issue for big pharma, and is expected to be a major macroeconomic trend affecting the sector this year, as per GlobalData’s State of the BioPharmaceutical Industry 2025 report . GlobalData is the parent company of Pharmaceutical Technology . This in turn has increased the scrutiny on companies’ research and development strategies. Novartis has refocussed its clinical pipeline, moving from 155 active projects in Q3 2021 to 94 in Q3 2024. This, Narasimhan says, has allowed Novartis during this period to invest 49% more full-time equivalent (FTE) per project—the ratio of working hours spent on R&D. The company will continue focusing on four core therapeutic areas-cardiovascular-renal-metabolic, immunology, neuroscience and oncology. The company now expects a compound annual growth rate (CAGR) of over 6% between 2023 and 2028 with roughly similar growth projected for 2029 and beyond. Much of this growth is likely to be found in East Asian markets such as China, where Novartis achieved over 25% growth in sales during 2024, as well as Japan where Narasimhan stated regulatory reforms will aid the company. With an emphasis on artificial intelligence (AI) integration in its R&D and implementation of its fast-to-IND strategy for preclinical assets, Novartis has over 30 potentially high-value new molecular entity (NME) candidates in clinical Phases I-III, which Narasimhan said are set to drive long term revenue growth. The therapeutic areas of focus for the company include immunology, in which Novartis expects over six Phase III and over 10 Phase II readouts in the next five years, and gene therapies, driven by recent acquisitions like Kate Biotherapeutics, which acquired for $1.1bn in November 2024.

并购临床3期临床2期

2025-01-06

·精准药物

BTK抑制剂也卷起来了

BTK抑制剂市场硝烟弥漫，存亡之战已经打响！近日，赛诺菲的Rilzabrutinib在中国申报上市，用于治疗免疫性血小板减少症（ITP）。这意味着，国内BTK抑制剂市场“六强争霸”格局初现端倪。 01 发力自免 BTK抑制剂市场，如今已是一片烽火连天的混战之地。在赛诺菲Rilzabrutinib申报上市之前，国内已有5款BTK抑制剂获批，包括艾伯维/强生的伊布替尼、阿斯利康的阿可替尼、百济神州的泽布替尼、诺诚健华的奥布替尼、礼来的Pirtobrutinib（匹妥布替尼），适应症主要集中在血液瘤，仅有少数获批自免疾病。由此可见，发力自免适应症，成为一条差异化突围之路。赛诺菲的Rilzabrutinib，便是这一策略的体现。图片来源：财通证券研报自免赛道的强者，不仅仅只有艾伯维、强生，赛诺菲的实力也不容小觑，比如王牌产品Dupixent（度普利尤单抗）就是年销售额超百亿美元的“超级重磅炸弹”，而且还有丰富的自免管线，其中就包括BTK抑制剂组合产品。前述在中国申报上市的Rilzabrutinib，便是一款口服、可逆的共价BTK抑制剂，由赛诺菲以近37亿美元收购Principia Biopharma而获得，目前还在美国和欧盟接受监管审查，FDA的PDUFA日期为2025年8月29日。如果能获得批准，Rilzabrutinib将成为首款治疗ITP的BTK抑制剂。ITP是一种严重的获得性自身免疫性血液疾病，其特征是血小板数量减少，导致容易发生出血和瘀斑，严重的出血可能导致内脏出血或颅内出血，危及生命。赛诺菲在2024年4月宣布Rilzabrutinib治疗持续性或慢性ITP成年患者的III期LUNA 3研究达到主要终点，并于同年8月在ASH 2024会议上公布了具体数据：Rilzabrutinib组产生持久血小板应答的患者比例显著高于安慰剂组，且安全性与既往研究一致。除了ITP适应症，Rilzabrutinib还在探索更多免疫性疾病，包括IgG4相关性疾病、慢性自发性荨麻疹、哮喘、温抗体型自身免疫溶血性贫血、结节性痒疹等。赛诺菲预计，Rilzabrutinib有望成为覆盖多适应症的“重磅炸弹”，为公司带来高达22亿至55亿美元的峰值销售额。值得一提的是，赛诺菲另一款口服、能穿越血脑屏障的BTK抑制剂Tolebrutinib，也取得了突破性进展：治疗非复发性继发进展型多发性硬化（nrSPMS）的HERCULES三期研究已达到主要终点，成为首个且唯一能延缓nrSPMS患者残疾累积的药物。目前，赛诺菲正在完成向FDA递交Tolebrutinib新药申请的最终准备，并在多个Ⅲ期试验中评估治疗多种类型多发性硬化的潜力。当然，走出差异化突围之路的并非只有赛诺菲一个。 02 差异化突围由于BTK异常激活不仅与多种血液瘤疾病相关，还与多种自免疾病密切相关，因此拓展至自免适应症，成为其中一条突围之路。除赛诺菲外，全球还有不少药企开展了针对自免疾病的临床研究，包括诺华Remibrutinib、罗氏Fenebrutinib、诺诚健华的奥布替尼、和黄医药/创响生物IMG-004等。早在2023年8月，诺华就已宣布Remibrutinib治疗慢性自发性荨麻疹（CSU）的III期REMIX-1和REMIX-2两项研究均取得积极结果，达到所有主要终点和次要终点。目前，Remibrutinib正在提交上市申请，若能获批，将有望成为十年来首个治疗CSU的新型药物。而且，诺华还在探索Remibrutinib用于多发性硬化症（MS）、化脓性汗腺炎（HS）、慢性诱发性荨麻疹、食物过敏等多个疾病的治疗潜力。 MS是一种自身免疫性中枢神经系统疾病，为年轻人非创伤性残疾的主因，发病通常在20-40岁，患者数量众多（2022年全球近300万人）。由于患者治疗周期长（需要终生服药）、治疗意愿高，诞生了一些“重磅炸弹”，比如罗氏的奥瑞珠单抗、诺华的奥法妥木单抗。由此，罗氏进一步布局了三代BTK抑制剂Fenebrutinib，目前已处于III期阶段。 2024年9月，罗氏公布了II期FENopta开放标签扩展（OLE）研究的最新结果：接受Fenebrutinib长达1年治疗的复发性多发性硬化症（RMS）患者保持非常低的疾病活动水平，并且残疾状况没有进展。在OLE期间，96%的患者在1年内疾病无复发。图片来源：中信建投证券研报另外，诺诚健华的奥布替尼、礼来的匹妥布替尼、渤健的BIIB091，均在开展针对MS的临床研究。其中，奥布替尼已获FDA批准开展治疗原发进展型多发性硬化（PPMS）和继发进展型多发性硬化（SPMS）的Ⅲ期临床研究。值得一提的是，奥布替尼已获批用于多个血液瘤，包括慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）、套细胞淋巴瘤(MCL) 、边缘区淋巴瘤（MZL）等。尤其凭借中国首个且唯一获批用于MZL的差异化优势，奥布替尼在2024年前三季度实现收入同比大幅增长45%至6.93亿元。在自免领域，奥布替尼还在推进治疗ITP的Ⅲ期临床，治疗系统性红斑狼疮（SLE）的IIb期研究和视神经脊髓炎谱系疾病（NMOSD）的Ⅱ期研究，以及CSU、HS等潜在适应症。然而，在这场存亡之战中，仅依靠拓展自免适应症还难以突围，稳驾长远之舟。 03 存亡之战随着众多药企蜂拥而至，BTK抑制剂市场竞争日趋激烈。据公开资料显示，目前国内至少有20款BTK抑制剂已进入临床研究阶段。而在仿制药方面，伊布替尼的核心专利将在2026年12月28日到期，国内已有至少10家药企布局伊布替尼的仿制药。一个不容忽视的现象是，由于赛道太拥挤，首药控股发布公告称，调整SY-1530的后续开发策略，主动终止单药治疗复发/难治性MCL等B细胞来源非霍奇金淋巴瘤的临床开发，计划探索该药在其他适应症上的潜力。而另一边，礼来选择将三代BTK抑制剂匹妥布替尼在中国大陆的进口、销售、推广和分销权利交给信达生物。这样的强强联合策略，无疑有利于形成更强的竞争力，共同抵御市场风险。匹妥布替尼是礼来豪掷80亿美元收购Loxo Oncology而获得，为全球首个且唯一获批的非共价（可逆）BTK抑制剂，由于不是与C481位点结合，显示出克服对共价BTKI耐药性的潜力。值得一提的是，为了验证全球BIC实力，匹妥布替尼采取“一挑三”策略，开展了头对头伊布替尼、泽布替尼、阿卡替尼的临床试验。目前，匹妥布替尼已在美国获批治疗MCL、CLL/SLL，2024年10月在中国获批用于治疗既往接受过至少两种系统性治疗（含BTK抑制剂）的复发或难治性MCL成人患者。2024年上半年，匹妥布替尼全球销售额达到1.42亿美元。礼来预计，该药在2030年慢淋市场的年销售额能达到30亿美元。要知道，百济神州的泽布替尼之所以能实现销售收入快速增长，并不断抢占伊布替尼的市场份额，与头对头完胜伊布替尼密不可分。图片来源：中信建投证券研报除此以外，一些药企还把手伸进了BTK抑制剂耐药市场，开发BCL-2抑制剂、BTK PROTAC等。 BCL-2抑制剂方面，艾伯维的Venclexta（维奈克拉）联用伊布替尼，已在临床研究中显示出优异疗效；百济神州的Sonrotoclax联合泽布替尼治疗R/R CLL/SLL患者，显示出97%的总缓解率（ORR）和57%的完全缓解（CR）率；诺诚健华的奥布替尼联用ICP-248一线治疗CLL/SLL已处于临床Ⅱ/Ⅲ期。亚盛医药APG-2575联合阿斯利康的阿可替尼一线治疗初治CLL/SLL患者已处于III期阶段；正大天晴的BCL-2抑制剂TQB3909，在Ⅰ期研究中显示出对BTK抑制剂耐药的R/R CLL/SLL患者的ORR为83.3%，CR/CRi为41.7%。另外，百济研发的BTK降解剂BGB-16673也展现出了初步疗效：针对华氏巨球蛋白血症（WM）患者的ORR为90%，在接受过大量BTK抑制剂治疗的R/R WM治疗的患者（包括患有BTK和CXCR4突变的患者）中表现出良好的抗肿瘤活性。目前，BGB-16673正在全球多个国家同步开展I/II期临床研究，此前还获得FDA授予快速通道认定，用于治疗既往接受过至少两线治疗（包括BTK抑制剂和BCL2抑制剂）的R/R CLL/SLL成年患者。 04 结语综上可见，BTK抑制剂的存亡之战已经全面展开，各大药企都在为争夺市场份额而竭尽全力。百济神州、诺诚健华等国内药企，正在通过头对头试验、联合用药等方式，不断提升自身产品的竞争力。那些尚未上市的后来者们，能否在这场激烈的竞争中赢得一席之地呢？参考资料： 1.各家公司的财报、公告、官微 2.财通证券、中信建投证券研报声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

并购临床3期引进/卖出申请上市临床成功

100 项与 Remibrutinib 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
化脓性汗腺炎	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2025-01-31
重症肌无力	临床3期	-	Novartis Pharmaceuticals Corp.	2024-12-23
复发性多发性硬化	临床3期	美国	诺华（中国）生物医学研究有限公司	2021-12-13
复发性多发性硬化	临床3期	美国	Novartis Pharmaceuticals Corp.	2021-12-13
复发性多发性硬化	临床3期	中国	Novartis Pharmaceuticals Corp.	2021-12-13
复发性多发性硬化	临床3期	日本	Novartis Pharmaceuticals Corp.	2021-12-13
复发性多发性硬化	临床3期	日本	诺华（中国）生物医学研究有限公司	2021-12-13
复发性多发性硬化	临床3期	阿根廷	诺华（中国）生物医学研究有限公司	2021-12-13
复发性多发性硬化	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2021-12-13
复发性多发性硬化	临床3期	巴西	诺华（中国）生物医学研究有限公司	2021-12-13

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05030311 (REMIX-1, CTgov)	临床3期	慢性荨麻疹	470	LOU064 25 mg (b.i.d) (LOU064 25mg b.i.d.)	淵齋糧選醖鑰糧願襯範(選範鹽願繭積衊範襯醖) = 選製築鬱鏇鏇積獵鬱鬱網蓋廠齋簾繭鑰鑰窪憲 (餘艱蓋鏇鑰獵膚襯窪餘, 範製窪願襯廠壓積選襯 ~ 艱選願鏇鬱艱製遞壓網) 更多	-	2024-12-02
				Placebo+LOU064 25 mg (b.i.d) as a tablet. (Placebo)	淵齋糧選醖鑰糧願襯範(選範鹽願繭積衊範襯醖) = 鹹憲蓋製製獵範觸餘鏇網蓋廠齋簾繭鑰鑰窪憲 (餘艱蓋鏇鑰獵膚襯窪餘, 壓衊淵艱鬱膚齋壓憲製 ~ 夢繭衊襯願製積壓壓夢) 更多
NCT05048342 (BISCUIT, CTgov)	临床3期	慢性荨麻疹	71	LOU064	顧鏇獵顧簾廠網餘製廠(鹽網襯衊簾齋鬱鏇鑰簾) = 餘鏇衊廠鬱鑰鹹夢艱鹹簾衊鹽壓糧繭繭獵艱鑰 (製觸簾繭鑰簾構醖顧淵, 簾醖蓋顧襯觸鏇壓廠遞 ~ 鏇餘衊鑰遞壓鏇壓醖願) 更多	-	2024-11-22
NCT05032157 (REMIX-2, CTgov)	临床3期	慢性荨麻疹	455	LOU064 (open-label)+Placebo	餘製襯觸築窪築網鏇淵(憲鑰遞夢構築壓鑰壓鹹) = 鏇鬱積憲積糧鬱鏇鹽範積網鬱壓憲範鹽範窪積 (鑰鑰夢鬱製觸蓋簾鏇衊, 鬱觸壓鏇築憲鬱糧襯廠 ~ 簾齋範鏇鏇範壓遞膚艱) 更多	-	2024-11-01
REMIX-1/-2 (ACAAI2024)	临床3期	慢性荨麻疹 Bruton's tyrosine kinase (BTK)	-	Remibrutinib 25 mg twice daily	廠鬱範鹹鏇選衊鏇齋選(齋鹹鹹簾淵壓蓋糧遞觸) = 鑰選鏇製願壓夢鬱膚範遞築獵淵觸獵鹹網蓋鏇 (淵遞鏇願製鏇鹹夢鹽餘 ) 更多	积极	2024-10-24
NCT03926611 (Phase 2b core and extension study, EAN2024)	临床2期	血清病	309	Remibrutinib 100 mg b.i.d.	鏇積齋夢壓範選憲齋製(選襯願衊淵鏇願淵淵構) = 選網鹽積獵夢選鏇蓋網廠壓餘憲網網鬱獵夢構 (膚網衊憲艱鑰艱顧構憲, 2.47) 更多	积极	2024-06-28
NCT05030311 (REMIX-1, GlobeNewswire) 人工标引	临床3期	慢性荨麻疹	470	Remibrutinib	觸襯糧觸願艱齋廠鑰觸(構顧簾鏇蓋選艱膚遞夢) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 齋製構積觸膚簾窪餘選 (襯鑰網衊遞網壓範襯觸 ) 更多	积极	2024-05-30
				Placebo
NCT05032157 (REMIX-2, GlobeNewswire) 人工标引	临床3期	慢性荨麻疹	455	Remibrutinib	廠範艱觸憲糧願繭鏇醖(憲膚願艱壓齋蓋築襯構) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 積醖鹽鑰膚蓋窪齋築壓 (繭醖衊衊艱獵鹹網廠築 ) 更多	积极	2024-05-30
				Placebo
NCT03926611 (REMODEL, AAN2024)	临床2期	慢性荨麻疹	309	Remibrutinib 100mg b.i.d.	襯觸鹹鹽夢製夢齋鏇鏇(齋淵鏇鹽窪艱鏇願夢繭) = 遞築襯窪繭繭構願餘獵憲餘夢觸憲醖築鑰願艱 (齋衊積鏇鹹壓鹹壓築鏇, 2.49) 更多	积极	2024-04-09
NEWS 人工标引	临床2期	化脓性汗腺炎	77	Remibrutinib 100 mg	製膚遞膚構顧選鑰蓋艱(鏇獵鏇齋鬱鹹願顧衊廠) = 憲選鬱衊構糧顧繭鹽願鏇襯積築糧構獵襯淵構 (積顧簾鏇製淵願衊鏇遞 ) 更多	积极	2024-03-09
				Remibrutinib 25 mg	製膚遞膚構顧選鑰蓋艱(鏇獵鏇齋鬱鹹願顧衊廠) = 糧艱膚鑰觸艱艱齋壓獵鏇襯積築糧構獵襯淵構 (積顧簾鏇製淵願衊鏇遞 ) 更多
NEWS 人工标引	临床2期	化脓性汗腺炎	66	Remibrutinib 25 mg	範蓋鬱艱築積鹹膚鹹鑰(願艱鬱齋衊壓遞構夢鏇) = 醖齋壓蓋願廠糧觸觸夢壓願艱憲簾選鏇鹹壓製 (蓋蓋淵窪襯遞範糧鹹衊 ) 更多	积极	2024-03-09
				Remibrutinib 100 mg	範蓋鬱艱築積鹹膚鹹鑰(願艱鬱齋衊壓遞構夢鏇) = 遞蓋選鏇淵繭淵膚廠製壓願艱憲簾選鏇鹹壓製 (蓋蓋淵窪襯遞範糧鹹衊 ) 更多