Iscalimab

1、研究机构：诺华制药 2、别名：LOU-064、Rhapsido、瑞普多、NVP-LOU064-NXA、瑞玛布鲁替尼、Rhapsido、Remibrutinib 3、靶点：BTK 4、剂型及给药途径：普通片剂; 口服给药；普通胶囊剂; 口服给药 5、结构式 6、适应症及进展 适应症 进展 最新进展日期 慢性自发性荨麻疹 批准上市 2025-09-30 症状性皮肤病 申请上市 2026-02-18 胆碱能性荨麻疹、寒冷性荨麻疹、慢性诱导性荨麻疹 III期 2026-02-18 慢性荨麻疹 II期 2025-05-22 多发性硬化 III期 2026-02-04 化脓性汗腺炎 III期 2026-02-11 重症肌无力 III期 2025-07-07 花生过敏 II期 2025-03-11 自身免疫性疾病、炎症 I期 2026-01-31 7、发表论文 标题 内容类型 适应症 企业 技术平台 来源 发表日期 Bruton’s Tyrosine Kinase Inhibitor Attenuates Skin Lesions in an Atopic Dermatitis Mouse Model by Suppressing Th2 Inflammation and Enhancing Skin Barrier Function 药理研究 特应性皮炎 西安交通大学医学院第二附属医院 2025 EADV 2025-09-17 Next generation Bruton's tyrosine kinase inhibitors - characterization of in vitro potency and selectivity 药理研究 自身免疫性疾病, 过敏 诺华制药 Eur J Pharmacol IF=4.7 2025-05-20 Discovery of LOU064 (Remibrutinib), a Potent and Highly Selective Covalent Inhibitor of Bruton's Tyrosine Kinase 药物发现 慢性自发性荨麻疹, 干燥综合征 诺华制药 J Med Chem IF=6.8 2020-05-28 LOU064: A Highly Selective and Potent Covalent Oral BTK Inhibitor with Promising Pharmacodynamic Efficacy on B Cells for Sjoegren’s Syndrome 药理研究 干燥综合征 诺华制药 ACR 2019-11-12 8、专利布局 公开（公告）号 专利主题 发明名称 申请日 法律状态 CN105683181B 化合物 新的氨基嘧啶衍生物 2014-11-28 CN113795255A 用途 使用布鲁顿酪氨酸激酶抑制剂治疗慢性自发性荨麻疹的方法 2020-05-20 实质审查 CN113811301A 用途 使用布鲁顿酪氨酸激酶抑制剂治疗舍格伦综合征的方法 2020-05-20 实质审查 CN113840821A 晶型 Btk抑制剂的晶型 2020-05-20 实质审查 CN118019540A 用途 用于治疗多发性硬化的lou064 2022-09-01 实质审查 CN118401242A 用途 使用LOU064的治疗方法 2022-12-12 实质审查 CN118742308A 用途 用于在治疗化脓性汗腺炎中使用的雷米布鲁替尼 2023-02-27 实质审查 US2025304538A1 制备工艺 制备基本不含亚硝胺杂质的瑞布替尼的方法 2025-03-31 实质审查 US2025243170A1 组合物 基本不含亚硝胺杂质的瑞布替尼药物物质和药物产品 2025-01-21 实质审查 CN119998265A 制备工艺 用于生产瑞布替尼的合成方法和中间体 2023-09-28 实质审查 CN120617264A 用途 用于在治疗化脓性汗腺炎中使用的雷米布鲁替尼 2023-02-27 实质审查 9、研究历程 上市信息 2025年09月30日，瑞米布替尼获得美国食品药品管理局FDA批准，由诺华制药销售。（https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu） 2025年09月30日，瑞米布替尼获得美国食品药品管理局FDA批准，由Novartis Pharmaceutical Corp销售，商品名为Rhapsido®。（NDA218436） 2025年11月25日，瑞米布替尼获得中国国家药品监督管理局NMPA批准，由Novartis Pharma Schweiz Ag销售，商品名为瑞普多®。（国药准字HJ20250136） 1) 慢性荨麻疹 2025年09月30日，该药获得美国食品药品管理局FDA批准，由诺华制药销售，该药获批上市。 2025年09月30日，该药获得美国食品药品管理局FDA批准，由Novartis Pharmaceutical Corp销售，商品名是Rhapsido®，为一种口服片剂，规格是25MG。 2025年11月25日，该药获得中国国家药品监督管理局NMPA批准，由Novartis Pharma Schweiz Ag销售，商品名是瑞普多®，为一种口服片剂，规格是25mg。 注：每个适应症的批准情况仅包括FDA、EMA、PMDA、NMPA的最早获批信息。 研发里程碑 2025年11月27日，由诺华（中国）生物医学研究有限公司在法国、德国和瑞士等国家和地区开展临床三期试验，用于治疗多发性硬化。（CTR20254664） 2025年10月23日，由诺华制药在美国开展临床二期试验，用于治疗多发性硬化和复发-缓解型多发性硬化。（NCT07222956） 2025年07月23日，由诺华制药在澳大利亚开展临床三期试验，用于治疗多发性硬化。（NCT07225504; NCT06846281） 2025年07月23日，由诺华制药在美国开展临床一期试验，用于治疗自身免疫疾病和炎性疾病。（NCT07032272） 2025年07月22日，由诺华（中国）生物医学研究有限公司在中国大陆开展临床三期试验，用于治疗化脓性汗腺炎。（CTR20251883） 2025年07月07日，由诺华（中国）生物医学研究有限公司在中国台湾和中国大陆开展临床三期试验，用于治疗重症肌无力。（CTR20252589） 2025年04月27日，由诺华制药在中国大陆开展临床一期试验，用于治疗化脓性汗腺炎和重症肌无力。（JXHL2500025; JXHL2500026; JXHL2500024） 2025年04月22日，由诺华（中国）生物医学研究有限公司在阿根廷、澳大利亚和比利时等国家和地区开展临床三期试验，用于治疗重症肌无力。（CTR20252589） 2025年03月20日，由诺华（中国）生物医学研究有限公司和诺华制药在阿根廷、澳大利亚和奥地利等国家和地区开展临床三期试验，用于治疗化脓性汗腺炎。（NCT06840392; CTR20251883） 2025年02月27日，由Novartis Pharma Schweiz Ag向中国国家药品监督管理局NMPA提交上市申请，用于治疗慢性荨麻疹。（JXHS2500034） 2025年02月11日，由诺华制药向中国国家药品监督管理局NMPA提交IND申请，用于治疗化脓性汗腺炎和重症肌无力。（JXHL2500025; JXHL2500026; JXHL2500024） 2025年02月07日，由诺华制药在阿根廷、澳大利亚和比利时等国家和地区开展临床三期试验，用于治疗重症肌无力。（NCT06744920） 2025年01月31日，由诺华制药在阿根廷、澳大利亚和保加利亚等国家和地区开展临床三期试验，用于治疗化脓性汗腺炎。（NCT06799000; NCT06840392） 2024年05月21日，由诺华（中国）生物医学研究有限公司在中国香港和中国大陆开展临床三期试验，用于治疗慢性荨麻疹。（CTR20231310） 2023年12月07日，由诺华制药在葡萄牙、罗马尼亚和以色列等国家和地区开展临床三期试验，用于治疗慢性荨麻疹。（NCT05976243） 2023年07月24日，由诺华（中国）生物医学研究有限公司在阿根廷、加拿大和智利等国家和地区开展临床三期试验，用于治疗慢性荨麻疹。（CTR20231310） 2023年07月11日，由诺华制药在智利、中国香港和荷兰等国家和地区开展临床三期试验，用于治疗慢性荨麻疹。（NCT05677451; NCT06042478; NCT05976243） 2023年02月07日，由诺华（中国）生物医学研究有限公司在中国香港和中国大陆开展临床三期试验，用于治疗多发性硬化。（CTR20254664; CTR20221734） 2022年12月20日，治疗Sjogren-Larsson综合征的研究终止。（NCT04035668） 2022年12月10日，由诺华（中国）生物医学研究有限公司在阿根廷、法国和土耳其等国家和地区开展临床三期试验，用于治疗荨麻疹。（CTR20230631） 2022年10月31日，由诺华制药在匈牙利开展临床一期试验，用于治疗肝功能衰退。（NCT05753592） 2022年10月12日，由诺华制药在美国开展临床二期试验，用于治疗花生过敏。（NCT05432388） 2022年09月15日，由诺华（中国）生物医学研究有限公司在中国大陆开展临床三期试验，用于治疗复发-缓解型多发性硬化。（CTR20221477） 2022年08月19日，由诺华（中国）生物医学研究有限公司在中国大陆开展临床一期试验，用于治疗多发性硬化。（CTR20221433） 2022年04月26日，治疗Sjtoegren综合征的研究终止。（CTR20192371） 2022年02月25日，由诺华制药在中国大陆开展临床一期试验，用于治疗多发性硬化。（JXHL2101264; JXHL2101263） 2022年02月08日，由诺华（中国）生物医学研究有限公司在中国台湾和中国大陆开展临床三期试验，用于治疗荨麻疹。（CTR20230631; CTR20213430） 2022年01月31日，由诺华（中国）生物医学研究有限公司在阿根廷、比利时和保加利亚等国家和地区开展临床三期试验，用于治疗多发性硬化。（CTR20221734） 2022年01月10日，由诺华（中国）生物医学研究有限公司在阿根廷、巴西和保加利亚等国家和地区开展临床三期试验，用于治疗复发-缓解型多发性硬化。（CTR20221477） 2021年12月16日，由诺华制药在奥地利、比利时和智利等国家和地区开展临床三期试验，用于治疗多发性硬化。（NCT05147220; NCT07225504; NCT06846281） 2021年12月13日，由诺华制药在阿根廷、巴西和保加利亚等国家和地区开展临床三期试验，用于治疗多发性硬化。（NCT05156281; NCT05147220; NCT07225504; NCT06846281） 2021年12月10日，由诺华（中国）生物医学研究有限公司在奥地利、巴西和加拿大等国家和地区开展临床三期试验，用于治疗荨麻疹。（CTR20230631; CTR20213430） 2021年12月01日，由诺华制药在奥地利、巴西和加拿大等国家和地区开展临床三期试验，用于治疗慢性荨麻疹。（NCT05032157; NCT05795153; NCT05513001; NCT05677451; NCT06042478; NCT05976243） 2021年12月01日，由诺华制药向中国国家药品监督管理局NMPA提交IND申请，用于治疗多发性硬化。（JXHL2101264; JXHL2101263） 2021年11月30日，由诺华制药在阿根廷、澳大利亚和保加利亚等国家和地区开展临床三期试验，用于治疗慢性荨麻疹。（NCT05032157; NCT05795153; NCT05030311; NCT05513001; NCT06868212; NCT05677451; NCT05048342; NCT06042478; NCT05976243） 2020年07月09日，由诺华（中国）生物医学研究有限公司在中国台湾和中国大陆开展临床二期试验，用于治疗Sjtoegren综合征。（CTR20192371） 2020年06月26日，治疗哮喘的研究终止。（CTR20200089; NCT03944707） 2020年04月10日，治疗哮喘的研究终止。（CTR20200089） 2020年02月16日，治疗皮炎和疾病易感性的研究暂无进展。（NCT03918980） 2020年01月19日，由诺华（中国）生物医学研究有限公司和诺华制药在中国大陆开展临床二期试验，用于治疗哮喘。（CTR20200089） 2019年09月18日，由诺华（中国）生物医学研究有限公司在比利时、保加利亚和丹麦等国家和地区开展临床二期试验，用于治疗Sjtoegren综合征。（CTR20192371） 2019年08月20日，由诺华（中国）生物医学研究有限公司在阿根廷、德国和波兰等国家和地区开展临床二期试验，用于治疗哮喘。（CTR20200089） 2019年07月18日，由诺华制药在阿根廷、德国和波兰等国家和地区开展临床二期试验，用于治疗哮喘。（CTR20200089; NCT03944707） 2019年07月12日，由诺华制药在澳大利亚、比利时和保加利亚等国家和地区开展临床二期试验，用于治疗Sjogren-Larsson综合征。（NCT04035668） 2019年06月06日，由诺华制药在阿根廷、比利时和加拿大等国家和地区开展临床二期试验，用于治疗慢性荨麻疹。（NCT03926611; NCT06865651; NCT04109313） 2016年08月18日，由诺华制药在德国和荷兰开展临床一期试验，用于治疗皮炎和疾病易感性。（NCT03918980） 10、临床试验 登记号 试验标题 试验药 适应症 原始适应症 申办/合作机构 试验状态 试验分期 开始日期 完成日期 国家/地区 NCT07225504 A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis 瑞米布替尼 (片剂, 口服) 继发进展型多发性硬化 Secondary Progressive Multiple Sclerosis (SPMS) Novartis Pharmaceuticals Canada, Inc. Recruiting 临床3期 2025-11-11 2034-01-02 加拿大 | 美国 | 以色列 | 澳大利亚 | 瑞士 | 印度 NCT07222956 An Open-label, Single-center Study of Remibrutinib Using Ultra High-field (7T) MR Imaging in Relapsing or Progressive MS (RemiSeven) 瑞米布替尼 原发性进行性多发性硬化 | 继发进展型多发性硬化 | 复发-缓解型多发性硬化 Multiple Sclerosis (MS) - Relapsing-remitting | Multiple Sclerosis (MS) Secondary Progressive | Multiple Sclerosis (MS) Primary Progressive The Cleveland Clinic Foundation | Novartis Pharmaceuticals Canada, Inc. Not yet recruiting 临床2期 2026-04-01 2030-12-30 美国 NCT07032272 A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Safety of Remibrutinib (LOU064) in Participants With Severe Renal Impairment Compared to Matched Healthy Participants With Normal Renal Function 瑞米布替尼 自身免疫性疾病 | 肾功能不全 | 慢性肾病 Autoimmune and Chronic Inflammatory Diseases Novartis Pharmaceuticals Canada, Inc. Completed 临床1期 2025-07-23 2025-10-14 美国 NCT06868212 A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-Antihistamines 瑞米布替尼 (薄膜包衣片, 口服) 慢性荨麻疹 Chronic Spontaneous Urticaria (CSU) Novartis Pharmaceuticals Canada, Inc. Recruiting 临床3期 2025-07-11 2027-05-17 美国 NCT06865651 A 12-week Randomized, Participant and Investigator-blinded, Placebo-controlled, Exploratory Study in Adult Participants With Chronic Urticaria to Assess the Efficacy and Safety and Explore the Mechanism of Action of Remibrutinib (LOU064) 瑞米布替尼 (片剂) 慢性荨麻疹 Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU) Novartis Pharmaceuticals Canada, Inc. Recruiting 临床2期 2025-05-22 2027-10-07 美国 | 波兰 | 法国 | 德国 | 西班牙 NCT06846281 A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib 瑞米布替尼 (片剂, 口服) 复发性多发性硬化 Relapsing Multiple Sclerosis Novartis Pharmaceuticals Canada, Inc. Recruiting 临床3期 2025-07-23 2031-06-20 阿根廷 | 美国 | 英国 | 瑞士 | 葡萄牙 | 西班牙 | 希腊 | 加拿大 | 比利时 | 丹麦 | 南非 | 墨西哥 | 意大利 | 斯洛伐克 | 法国 | 澳大利亚 NCT06840392 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 and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE-2) 瑞米布替尼 (口服) 化脓性汗腺炎 Hidradenitis Suppurativa Novartis Pharmaceuticals Canada, Inc. Recruiting 临床3期 2025-03-20 2028-03-17 哥伦比亚 | 美国 | 阿根廷 | 罗马尼亚 | 匈牙利 | 捷克 | 英国 | 马来西亚 | 西班牙 | 希腊 | 加拿大 | 奥地利 | 比利时 | 土耳其 | 波兰 | 墨西哥 | 法国 | 德国 NCT06799000 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 and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa. (RECHARGE-1) 瑞米布替尼 (口服) 化脓性汗腺炎 Hidradenitis Suppurativa Novartis Pharmaceuticals Canada, Inc. Recruiting 临床3期 2025-01-31 2028-02-18 哥伦比亚 | 阿根廷 | 美国 | 马来西亚 | 瑞士 | 葡萄牙 | 西班牙 | 希腊 | 加拿大 | 中国 | 中国台湾 | 波兰 | 丹麦 | 南非 | 墨西哥 | 意大利 | 斯洛伐克 | 保加利亚 | 澳大利亚 | 德国 NCT06744920 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 瑞米布替尼 重症肌无力 Generalized Myasthenia Gravis Novartis Pharmaceuticals Canada, Inc. Recruiting 临床3期 2025-02-07 2033-02-26 阿根廷 | 罗马尼亚 | 美国 | 日本 | 西班牙 | 印度 | 加拿大 | 韩国 | 比利时 | 中国 | 中国台湾 | 波兰 | 意大利 | 法国 | 澳大利亚 CTRI/2024/08/072230 A 52-week multi-center, randomized, double-blind, placebo controlled, basket study with an open-label extension to investigate the efficacy, safety, and tolerability of remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in adults inadequately controlled by H1-antihistamines - NIL 瑞米布替尼 - Health Condition 1: L505- Cholinergic urticariaHealth Condition 2: L503- Dermatographic urticariaHealth Condition 3: L502- Urticaria due to cold and heat Novartis Healthcare Pvt Ltd. Completed 临床3期 2024-08-20 2025-05-28 阿根廷 | 澳大利亚 | 巴西 | 加拿大 | 中国 | 哥伦比亚 | 法国 | 德国 | 中国香港 | 匈牙利 | 印度 | 以色列 | 意大利 | 日本 | 马来西亚 | 荷兰 | 波兰 | 葡萄牙 | 罗马尼亚 | 新加坡 | 斯洛伐克 | 南非 | 西班牙 | 泰国 | 土耳其 | 英国 | 美国 NCT06042478 A Global, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib 25 mg b.i.d. in Comparison to Placebo With Omalizumab 300 mg Every 4 Weeks as Active Control Over 52 Weeks in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines and an Open-label 52-week Optional Extension to Assess Long-term Efficacy, Safety and Tolerability of Remibrutinib 25 mg b.i.d. 瑞米布替尼 慢性荨麻疹 Chronic Spontaneous Urticaria Novartis Pharmaceuticals Corp. Active, not recruiting 临床3期 2023-11-15 2027-07-20 阿根廷 | 匈牙利 | 捷克 | 英国 | 马来西亚 | 泰国 | 瑞士 | 西班牙 | 印度 | 加拿大 | 越南 | 韩国 | 荷兰 | 土耳其 | 中国台湾 | 波兰 | 巴西 | 墨西哥 | 意大利 | 斯洛伐克 | 法国 | 保加利亚 | 德国 NCT05976243 A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in Adults Inadequately Controlled by H1-antihistamines 瑞米布替尼 慢性荨麻疹 Chronic Inducible Urticaria Novartis Pharmaceuticals Corp. Active, not recruiting 临床3期 2023-12-07 2028-08-01 新加坡 | 中国香港 | 美国 | 马来西亚 | 泰国 | 葡萄牙 | 越南 | 韩国 | 荷兰 | 中国 | 土耳其 | 波兰 | 巴西 | 斯洛伐克 | 法国 | 哥伦比亚 | 阿根廷 | 罗马尼亚 | 匈牙利 | 日本 | 英国 | 西班牙 | 印度 | 加拿大 | 意大利 | 以色列 | 澳大利亚 | 德国 NCT05795153 A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks. 瑞米布替尼 (薄膜包衣片) 慢性荨麻疹 Chronic Spontaneous Urticaria Novartis Pharmaceuticals Corp. Completed 临床3期 2023-04-05 2024-04-25 加拿大 | 韩国 | 阿根廷 | 新加坡 | 美国 | 土耳其 | 斯洛伐克 | 法国 | 德国 | 西班牙 NCT05753592 A Phase 1, Open-label, Study to Investigate the Pharmacokinetics and Safety of Remibrutinib (LOU064) in Participants With Hepatic Impairment Compared to Matched Healthy Participants With Normal Hepatic Function 瑞米布替尼 (口服) 肝功能不全 | 肝损伤 Hepatic Impairment Novartis Pharmaceuticals Corp. Completed 临床1期 2022-10-31 2023-12-17 匈牙利 NCT05677451 A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years 瑞米布替尼 慢性荨麻疹 Chronic Spontaneous Urticaria Novartis Pharmaceuticals Corp. Recruiting 临床3期 2023-07-11 2032-03-30 阿根廷 | 新加坡 | 中国香港 | 美国 | 日本 | 英国 | 马来西亚 | 泰国 | 西班牙 | 加拿大 | 荷兰 | 土耳其 | 中国 | 波兰 | 南非 | 意大利 | 智利 | 德国 CTR20221433 一项在中国健康受试者中评估食物对LOU064（remibrutinib）薄膜衣片（FCT）稳态药代动力学影响的随机、开放性、两队列、两周期、两序列、交叉组研究 瑞米布替尼 (片剂, 口服) 多发性硬化症 复发型多发性硬化 诺华（中国）生物医学研究有限公司 Completed 临床1期 2022-08-15 2022-11-18(国内) 中国 NCT05432388 A One Month, Investigator and Participant Blinded Study to Investigate the Efficacy and Safety of Remibrutinib (LOU064) at Multiple Dose Levels in Adult Participants With Peanut Allergy 瑞米布替尼 (口服凝胶剂, 口服) 花生过敏 Allergy, Peanut Novartis Pharmaceuticals Corp. Completed 临床2期 2022-10-12 2025-03-11 美国 CTRI/2022/02/040428 A multicenter, randomized, double-blind, placebo-controlled Phase 3 study ofremibrutinib (LOU064) to investigate the efficacy, safety and tolerability for52 weeks in adult chronic spontaneous urticaria patients inadequatelycontrolled by H1-antihistamines 瑞米布替尼 - Health Condition 1: L508- Other urticaria Novartis Healthcare Pvt Ltd. Completed 临床3期 2022-02-28 2024-01-16 阿根廷 | 澳大利亚 | 保加利亚 | 哥伦比亚 | 捷克 | 法国 | 匈牙利 | 印度 | 意大利 | 日本 | 墨西哥 | 葡萄牙 | 韩国 | 俄罗斯 | 西班牙 | 中国台湾 | 土耳其 | 美国 NCT05170724 Managed Access Program (MAP) Cohort Treatment Plan CLOU064A2002M to Provide Access to Remibrutinib for Adult Patients With Chronic Spontaneous Urticaria (CSU) 瑞米布替尼 慢性荨麻疹 Chronic Spontaneous Urticaria Novartis Pharmaceuticals Canada, Inc. Available N/A - - - NCT05156281 A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib 瑞米布替尼 (片剂, 口服) 复发性多发性硬化 Relapsing Multiple Sclerosis Novartis Pharmaceuticals Corp. Active, not recruiting 临床3期 2021-12-13 2030-10-30 美国 | 捷克 | 葡萄牙 | 希腊 | 瑞典 | 中国 | 土耳其 | 波兰 | 巴西 | 斯洛文尼亚 | 斯洛伐克 | 法国 | 保加利亚 | 克罗地亚 | 阿根廷 | 罗马尼亚 | 日本 | 英国 | 西班牙 | 印度 | 加拿大 | 南非 | 墨西哥 | 意大利 | 德国 | 爱沙尼亚 NCT05147220 A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib 瑞米布替尼 (片剂, 口服) 复发性多发性硬化 Relapsing Multiple Sclerosis Novartis Pharmaceuticals Corp. Active, not recruiting 临床3期 2021-12-16 2030-10-30 中国香港 | 美国 | 马来西亚 | 沙特阿拉伯 | 荷兰 | 拉脱维亚 | 奥地利 | 爱尔兰 | 中国 | 土耳其 | 波兰 | 危地马拉 | 巴西 | 斯洛伐克 | 立陶宛 | 约旦 | 智利 | 保加利亚 | 克罗地亚 | 哥伦比亚 | 阿根廷 | 英国 | 阿拉伯联合酋长国 | 瑞士 | 西班牙 | 印度 | 黎巴嫩 | 比利时 | 中国台湾 | 丹麦 | 墨西哥 | 意大利 | 以色列 NCT05048342 A Multicenter, Open-label Phase 3 Study of Remibrutinib (LOU064) to Investigate the Safety, Tolerability and Efficacy for 52 Weeks in Adult Japanese Chronic Spontaneous Urticaria Patients Inadequately Controlled by H1-antihistamines 瑞米布替尼 (薄膜包衣片) 慢性荨麻疹 Chronic Spontaneous Urticaria Novartis Pharmaceuticals Corp. Completed 临床3期 2022-01-15 2023-12-09 日本 NCT05032157 A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines 瑞米布替尼 慢性荨麻疹 Chronic Spontaneous Urticaria Novartis Pharmaceuticals Corp. Completed 临床3期 2021-12-01 2024-01-05 俄罗斯 | 美国 | 英国 | 马来西亚 | 泰国 | 瑞士 | 印度 | 加拿大 | 越南 | 奥地利 | 中国 | 中国台湾 | 波兰 | 丹麦 | 巴西 | 南非 | 斯洛伐克 | 德国 NCT05030311 A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines 瑞米布替尼 (片剂, 口服) 慢性荨麻疹 Chronic Spontaneous Urticaria Novartis Pharmaceuticals Corp. Completed 临床3期 2021-11-30 2024-01-19 哥伦比亚 | 俄罗斯 | 美国 | 阿根廷 | 新加坡 | 匈牙利 | 捷克 | 日本 | 西班牙 | 印度 | 土耳其 | 中国台湾 | 韩国 | 墨西哥 | 意大利 | 法国 | 保加利亚 | 澳大利亚 NCT04109313 An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in CLOU064A2201 瑞米布替尼 慢性荨麻疹 Chronic Spontaneous Urticaria Novartis Pharmaceuticals Corp. Completed 临床2期 2019-10-24 2022-09-09 俄罗斯 | 阿根廷 | 匈牙利 | 捷克 | 美国 | 日本 | 英国 | 西班牙 | 加拿大 | 土耳其 | 比利时 | 波兰 | 丹麦 | 斯洛伐克 | 法国 NCT04035668 An Adaptive Phase 2 Randomized Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Multiple LOU064 Doses in Patients With Moderate to Severe Sjögren's Syndrome (LOUiSSe) 瑞米布替尼 干燥综合征 Sjögren Syndrome Novartis Pharmaceuticals Canada, Inc. Terminated 临床2期 2019-07-12 2021-11-23 匈牙利 | 比利时 | 美国 | 中国 | 中国台湾 | 丹麦 | 英国 | 保加利亚 | 澳大利亚 | 瑞士 | 德国 | 西班牙 NL-OMON49324 A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LOU064 following a single dose of [14C]LOU064 administered orally or intravenouslyl in healthy male and female subjects at steady-state. - ADME of LOU064 following a single dose of [14C]LOU064 瑞米布替尼 自身免疫性疾病 autoimmune and chronic inflammatory diseases | 10003816 Novartis AG Completed N/A 2019-08-29 - 荷兰 NCT03944707 A Randomized, Subject- and Investigator-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of LOU064 in Patients With Inadequately Controlled Asthma 瑞米布替尼 哮喘 Asthma Novartis Pharmaceuticals Corp. Terminated 临床2期 2019-07-18 2020-04-27 俄罗斯 | 阿根廷 | 美国 | 波兰 | 德国 NCT03926611 A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines 瑞米布替尼 慢性荨麻疹 Chronic Spontaneous Urticaria Novartis Pharmaceuticals Canada, Inc. Completed 临床2期 2019-06-06 2021-04-15 俄罗斯 | 阿根廷 | 匈牙利 | 捷克 | 美国 | 日本 | 英国 | 西班牙 | 加拿大 | 荷兰 | 土耳其 | 比利时 | 波兰 | 丹麦 | 斯洛伐克 | 法国 | 德国 NCT03918980 A 6-part First-in-human Study of LOU064 Consisting of a 4-part Randomized, Double-blind, Placebo-controlled SAD and MAD Study to Investigate the Safety and Tolerability in Healthy Volunteers, Subjects With Atopic Diathesis and Subjects With Atopic Dermatitis, an Open-label Food Effect Study and a Double-blind Formulation Effect Study in Healthy Volunteers 瑞米布替尼 特应性皮炎 Healthy Volunteers, Atopic Diathesis and Atopic Dermatitis Novartis Pharmaceuticals Corp. Completed 临床1期 2016-08-18 2020-01-27 荷兰 | 德国 NCT03827798 A Randomized, Subject and Investigator Blinded, Placebo-controlled and Multi-center Platform Study, to Assess Efficacy and Safety of Different Investigational Drugs in Patients With Moderate to Severe Hidradenitis Suppurativa 瑞米布替尼 | LYS-006 | MAS-825 | 伊利尤单抗 | Iscalimab 化脓性汗腺炎 Hidradenitis Suppurativa Novartis Pharmaceuticals Corp. Active, not recruiting 临床2期 2019-02-27 2026-12-11 荷兰 | 奥地利 | 匈牙利 | 比利时 | 捷克 | 美国 | 丹麦 | 法国 | 冰岛 | 德国 | 西班牙 NL-OMON46164 A 6-part first-in-human study of LOU064 consisting of a 4 part randomized, double-blind, placebo-controlled SAD and MAD study to investigate the safety and tolerability in healthy volunteers, subjects with atopic diathesis and subjects with atopic dermatitis, an open-label food effect study and a double-blind formulation effect study in healthy volunteers - Safety, tolerability, and efficacy of LOU064 瑞米布替尼 特应性皮炎 Atopic dermatitis eczema | 10014982 Novartis AG Completed N/A 2019-03-08 2020-02-05 荷兰 CTIS2023-506760-13-00 A study to investigate the pharmacokinetics of remibrutinib in CSF in healthy participants. 瑞米布替尼 慢性荨麻疹 | 多发性硬化症 Healthy | Chronic spontaneous urticaria | Multiple sclerosis Novartis Pharma AG Completed 临床1期 2023-12-11 2024-03-17 荷兰 11、临床结果 标题 登记号 来源 分期 适应症 评价人数 用药方案 结果 评价 发布日期 申办/合作机构 来源链接 Synapse链接 Remibrutinib Showed a Favorable Safety Profile and Sustained Efficacy in Japanese Patients with Chronic Spontaneous Urticaria Over 52 Weeks NCT05048342 Pubmed 临床3期 慢性荨麻疹 71 Remibrutinib 25 mg AE = 87.3 %  积极 2026-02-19 Novartis Pharmaceuticals Corp. https://pubmed.ncbi.nlm.nih.gov/41712058/ | https://doi.org/10.1007/s13555-026-01666-5 https://synapse.zhihuiya.com/clinical-result-detail/22a52503895add55e58382922ee5902d A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks. NCT05795153 CTgov 临床3期 慢性荨麻疹 144 LOU064 Estimated Mean Change From Baseline at Week 4 in 24-hour Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM)(Mean) = -1.3 mmHg (95%CI, -2.3 ~ -0.3) - 2025-04-30 Novartis Pharmaceuticals Corp. https://clinicaltrials.gov/ct2/show/results/NCT05795153 https://synapse.zhihuiya.com/clinical-result-detail/2da984894eae424e8e540242889a45a2 Remibrutinib Beneficial for Urticaria After H1-Antihistamine Treatment NCT05030311 | NCT05032157 NEWS 临床3期 荨麻疹 - remibrutinib(REMIX-1) UAS7(12-week) = -20.0 Point (SE, 0.7) 积极 2025-03-11 Novartis Pharmaceuticals Corp. https://www.drugs.com/news/remibrutinib-beneficial-urticaria-after-h1-antihistamine-124062.html | https://pubmed.ncbi.nlm.nih.gov/40043237/ https://synapse.zhihuiya.com/clinical-result-detail/8daed889d5a32e8a9aee885d3d88e422 Remibrutinib Beneficial for Urticaria After H1-Antihistamine Treatment NCT05030311 | NCT05032157 NEWS 临床3期 荨麻疹 - placebo(REMIX-1) UAS7(12-week) = -13.8 Point (SE, 1.0) 积极 2025-03-11 Novartis Pharmaceuticals Corp. https://www.drugs.com/news/remibrutinib-beneficial-urticaria-after-h1-antihistamine-124062.html | https://pubmed.ncbi.nlm.nih.gov/40043237/ https://synapse.zhihuiya.com/clinical-result-detail/8daed889d5a32e8a9aee885d3d88e422 Effect of Remibrutinib on Sleep and Daily Activities in Patients With Chronic Spontaneous Urticaria (CSU) up to Week 52 in the REMIX-1/-2 studies - AAD 临床3期 慢性荨麻疹 753 Remibrutinib SIS7=0(Week 24) = 58.9 %  积极 2025-03-07 - https://eposters.aad.org/abstracts/62278 https://synapse.zhihuiya.com/clinical-result-detail/a2d38a32e80888950282025548e29ad3 Effect of Remibrutinib on Sleep and Daily Activities in Patients With Chronic Spontaneous Urticaria (CSU) up to Week 52 in the REMIX-1/-2 studies - AAD 临床3期 慢性荨麻疹 753 Remibrutinib SIS7=0(Week 24) = 58.2 %  积极 2025-03-07 - https://eposters.aad.org/abstracts/62278 https://synapse.zhihuiya.com/clinical-result-detail/a2d38a32e80888950282025548e29ad3 Improvements in Itch and Hive Symptoms With Remibrutinib as Early as Week 1 in Patients With Chronic Spontaneous Urticaria (CSU) in REMIX-1/-2 - AAD 临床3期 慢性荨麻疹 753 Remibrutinib 25 mg Hives Severity Score(Week 1) = -6.0 Point ( 0.3) 积极 2025-03-07 - https://eposters.aad.org/abstracts/62280 https://synapse.zhihuiya.com/clinical-result-detail/25e2d455e829022da95e2582882a823d Improvements in Itch and Hive Symptoms With Remibrutinib as Early as Week 1 in Patients With Chronic Spontaneous Urticaria (CSU) in REMIX-1/-2 - AAD 临床3期 慢性荨麻疹 753 Remibrutinib 25 mg Hives Severity Score(Week 1) = -6.3 Point ( 0.3) 积极 2025-03-07 - https://eposters.aad.org/abstracts/62280 https://synapse.zhihuiya.com/clinical-result-detail/25e2d455e829022da95e2582882a823d Remibrutinib in patients with moderate to severe hidradenitis suppurativa: Patient reported outcomes from a randomized, phase 2, double-blind, placebo-controlled platform study NCT03827798 AAD 临床2期 化脓性汗腺炎 77 Remibrutinib 25mg DLQI(very/extremely large (11-30)) = 30.3 %  积极 2025-03-07 Novartis Pharmaceuticals Corp. https://eposters.aad.org/abstracts/62279 https://synapse.zhihuiya.com/clinical-result-detail/552858a052e2383d2542252928e2258e Remibrutinib in patients with moderate to severe hidradenitis suppurativa: Patient reported outcomes from a randomized, phase 2, double-blind, placebo-controlled platform study NCT03827798 AAD 临床2期 化脓性汗腺炎 77 Remibrutinib 100mg DLQI(very/extremely large (11-30)) = 24.2 %  积极 2025-03-07 Novartis Pharmaceuticals Corp. https://eposters.aad.org/abstracts/62279 https://synapse.zhihuiya.com/clinical-result-detail/552858a052e2383d2542252928e2258e Remibrutinib in Chronic Spontaneous Urticaria NCT05030311 | NCT05032157 Pubmed 临床3期 慢性荨麻疹 - Remibrutinib 25 mg twice daily UAS7 of 0 at week 12 = 31.1 %  积极 2025-03-06 Novartis Pharmaceuticals Corp. https://pubmed.ncbi.nlm.nih.gov/40043237/ | https://doi.org/10.1056/nejmoa2408792 https://synapse.zhihuiya.com/clinical-result-detail/e5e9882528288882320e0292382e8058 Remibrutinib in Chronic Spontaneous Urticaria NCT05030311 | NCT05032157 Pubmed 临床3期 慢性荨麻疹 - Placebo UAS7 of 0 at week 12 = 10.5 %  积极 2025-03-06 Novartis Pharmaceuticals Corp. https://pubmed.ncbi.nlm.nih.gov/40043237/ | https://doi.org/10.1056/nejmoa2408792 https://synapse.zhihuiya.com/clinical-result-detail/e5e9882528288882320e0292382e8058 A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines NCT05030311 CTgov 临床3期 慢性荨麻疹 470 LOU064(LOU064 25mg b.i.d.) Change From Baseline in Weekly Urticaria Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint)(LS Mean) = -20.02 Point  - 2024-12-02 Novartis Pharmaceuticals Corp. https://clinicaltrials.gov/ct2/show/results/NCT05030311 https://synapse.zhihuiya.com/clinical-result-detail/284a2e5554eae2add5ad5a508504eae2 A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines NCT05030311 CTgov 临床3期 慢性荨麻疹 470 Placebo+LOU064(Placebo) Change From Baseline in Weekly Urticaria Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint)(LS Mean) = -13.79 Point  - 2024-12-02 Novartis Pharmaceuticals Corp. https://clinicaltrials.gov/ct2/show/results/NCT05030311 https://synapse.zhihuiya.com/clinical-result-detail/284a2e5554eae2add5ad5a508504eae2 A Multicenter, Open-label Phase 3 Study of Remibrutinib (LOU064) to Investigate the Safety, Tolerability and Efficacy for 52 Weeks in Adult Japanese Chronic Spontaneous Urticaria Patients Inadequately Controlled by H1-antihistamines NCT05048342 CTgov 临床3期 慢性荨麻疹 71 LOU064 Subjects with at least one Adverse Event (AE) = 62 Pts  - 2024-11-22 Novartis Pharmaceuticals Corp. https://clinicaltrials.gov/ct2/show/results/NCT05048342 https://synapse.zhihuiya.com/clinical-result-detail/0099aa4534aee2e2a85434aa258e28ad A Post-hoc Analysis of Two Phase 2 Randomized Controlled Trials in Patients with Active Sjogren’s Disease Exploring the Novel Composite Endpoint Sjögren’s Tool for Assessing Response (STAR) NCT04035668 ACR 临床2期 - 346 remibrutinib ESSDAI(response rates) = 53.1 %  积极 2024-11-10 Novartis Pharmaceuticals Canada, Inc. https://acrabstracts.org/abstract/a-post-hoc-analysis-of-two-phase-2-randomized-controlled-trials-in-patients-with-active-sjogrens-disease-exploring-the-novel-composite-endpoint-sjogrens-tool-for-assessing-response/ https://synapse.zhihuiya.com/clinical-result-detail/ea3e224e02043e8a8930a05a20528438 A Post-hoc Analysis of Two Phase 2 Randomized Controlled Trials in Patients with Active Sjogren’s Disease Exploring the Novel Composite Endpoint Sjögren’s Tool for Assessing Response (STAR) NCT04035668 ACR 临床2期 - 346 Placebo ESSDAI(response rates) = 29.2 %  积极 2024-11-10 Novartis Pharmaceuticals Canada, Inc. https://acrabstracts.org/abstract/a-post-hoc-analysis-of-two-phase-2-randomized-controlled-trials-in-patients-with-active-sjogrens-disease-exploring-the-novel-composite-endpoint-sjogrens-tool-for-assessing-response/ https://synapse.zhihuiya.com/clinical-result-detail/ea3e224e02043e8a8930a05a20528438 A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines NCT05032157 CTgov 临床3期 慢性荨麻疹 455 LOU064 (open-label)+Placebo Mean Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint)(LS Mean) = -11.73 Unit on a scale  - 2024-11-01 Novartis Pharmaceuticals Corp. https://clinicaltrials.gov/ct2/show/results/NCT05032157 https://synapse.zhihuiya.com/clinical-result-detail/e55455958ee9292a5202e205842e28a8 NO CLINICALLY MEANINGFUL IMPACT OF REMIBRUTINIB ON IMMUNOGLOBULIN LEVELS OR INFECTIONS IN CHRONIC SPONTANEOUS URTICARIA - ACAAI 临床3期 慢性荨麻疹 - Remibrutinib 25 mg twice daily IgA = 2.2 g/L  积极 2024-10-24 Basel - SpA | Denver Zoo Conservation Alliance | Toronto Zoo | 上海国旅国际旅行社有限公司 | Berlin Heart GmbH https://www.annallergy.org/article/S1081-1206(24)00862-7/fulltext https://synapse.zhihuiya.com/clinical-result-detail/3098e0502e04025525d2555d889a385e Remibrutinib, a BTKi, has no impact on serum urticaria NCT03926611 EAN 临床2期 血清病 309 Remibrutinib 100 mg b.i.d. IgG levels = 10.5 μg/mL ( 2.47) 积极 2024-06-28 Novartis Pharmaceuticals Canada, Inc. https://onlinelibrary.wiley.com/doi/epdf/10.1111/ene.16338 https://synapse.zhihuiya.com/clinical-result-detail/52298852a23824e4aa9d2935e2980ea0 Novartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria NCT05030311 GlobeNewswire 临床3期 慢性荨麻疹 470 Remibrutinib UAS7(52-week) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52   积极 2024-05-30 Novartis Pharmaceuticals Corp. https://www.globenewswire.com/news-release/2024/05/30/2891212/0/en/Novartis-Phase-III-data-confirm-sustained-efficacy-and-long-term-safety-of-oral-remibrutinib-in-chronic-spontaneous-urticaria.html https://synapse.zhihuiya.com/clinical-result-detail/9903ea25243ae58e2528925ea824e255 Novartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria NCT05030311 GlobeNewswire 临床3期 慢性荨麻疹 470 Placebo UAS7(52-week) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52   积极 2024-05-30 Novartis Pharmaceuticals Corp. https://www.globenewswire.com/news-release/2024/05/30/2891212/0/en/Novartis-Phase-III-data-confirm-sustained-efficacy-and-long-term-safety-of-oral-remibrutinib-in-chronic-spontaneous-urticaria.html https://synapse.zhihuiya.com/clinical-result-detail/9903ea25243ae58e2528925ea824e255 Novartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria NCT05032157 GlobeNewswire 临床3期 慢性荨麻疹 455 Remibrutinib UAS7(52-week) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52   积极 2024-05-30 Novartis Pharmaceuticals Corp. https://www.globenewswire.com/news-release/2024/05/30/2891212/0/en/Novartis-Phase-III-data-confirm-sustained-efficacy-and-long-term-safety-of-oral-remibrutinib-in-chronic-spontaneous-urticaria.html https://synapse.zhihuiya.com/clinical-result-detail/d82d2253aa22328e5ead952304535eda Novartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria NCT05032157 GlobeNewswire 临床3期 慢性荨麻疹 455 Placebo UAS7(52-week) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52   积极 2024-05-30 Novartis Pharmaceuticals Corp. https://www.globenewswire.com/news-release/2024/05/30/2891212/0/en/Novartis-Phase-III-data-confirm-sustained-efficacy-and-long-term-safety-of-oral-remibrutinib-in-chronic-spontaneous-urticaria.html https://synapse.zhihuiya.com/clinical-result-detail/d82d2253aa22328e5ead952304535eda The Bruton’s Tyrosine Kinase Inhibitor Remibrutinib Exhibits No Impact on Serum Immunoglobulin Levels: Insights from Chronic Spontaneous Urticaria (P10-6.018) NCT03926611 AAN 临床2期 慢性荨麻疹 309 Remibrutinib 100mg b.i.d. IgG levels = 10.5 µg/mL ( 2.49) 积极 2024-04-09 Novartis Pharmaceuticals Canada, Inc. https://www.neurology.org/doi/full/10.1212/WNL.0000000000206293 https://synapse.zhihuiya.com/clinical-result-detail/282da928540ae029a522d290d83a285d Novel Drug Shows Promise for Moderate-to-Severe Hidradenitis Suppurativa - NEWS 临床2期 化脓性汗腺炎 77 Remibrutinib 100 mg HiSCR = 48.5 %  积极 2024-03-09 - https://www.medscape.com/viewarticle/novel-drug-shows-promise-moderate-severe-hidradenitis-2024a10004j5?form=fpf https://synapse.zhihuiya.com/clinical-result-detail/ee2a5588e829a8504e8eee2925ae9558 Novel Drug Shows Promise for Moderate-to-Severe Hidradenitis Suppurativa - NEWS 临床2期 化脓性汗腺炎 77 Remibrutinib 25 mg HiSCR = 72.7 %  积极 2024-03-09 - https://www.medscape.com/viewarticle/novel-drug-shows-promise-moderate-severe-hidradenitis-2024a10004j5?form=fpf https://synapse.zhihuiya.com/clinical-result-detail/ee2a5588e829a8504e8eee2925ae9558 Novartis' BTK inhibitor beats placebo in dermatology trial, lining up another potential indication - NEWS 临床2期 化脓性汗腺炎 66 Remibrutinib 25 mg RR = 73 %  积极 2024-03-09 - https://www.fiercebiotech.com/biotech/novartis-lines-another-potential-indication-btk-inhibitor-mid-stage-success-remibrutinib https://synapse.zhihuiya.com/clinical-result-detail/95453954555aeaee42a25aee0ee2a900 Novartis' BTK inhibitor beats placebo in dermatology trial, lining up another potential indication - NEWS 临床2期 化脓性汗腺炎 66 Remibrutinib 100 mg RR = 49 %  积极 2024-03-09 - https://www.fiercebiotech.com/biotech/novartis-lines-another-potential-indication-btk-inhibitor-mid-stage-success-remibrutinib https://synapse.zhihuiya.com/clinical-result-detail/95453954555aeaee42a25aee0ee2a900 Time to first relapse during treatment-free follow-up without remibrutinib in patients with chronic spontaneous urticaria (CSU): subgroup analysis by baseline disease status and CSU duration from a Phase 2b extension study NCT04109313 AAD 临床2期 慢性荨麻疹 98 Remibrutinib 100mg twice daily Relapse = 34.0 Pts  积极 2024-03-08 Novartis Pharmaceuticals Corp. https://eposters.aad.org/archives/AM2024/52859 https://synapse.zhihuiya.com/clinical-result-detail/25d92052edaa52adad995ee38ea585ae Time to first relapse during treatment-free follow-up without remibrutinib in patients with chronic spontaneous urticaria (CSU): subgroup analysis by baseline disease status and CSU duration from a Phase 2b extension study NCT04109313 AAD 临床2期 慢性荨麻疹 98 Remibrutinib 100mg twice daily Relapse = 15.0 Pts  积极 2024-03-08 Novartis Pharmaceuticals Corp. https://eposters.aad.org/archives/AM2024/52859 https://synapse.zhihuiya.com/clinical-result-detail/25d92052edaa52adad995ee38ea585ae Remibrutinib provides sustained improvement in itch severity in patients with chronic spontaneous urticaria: Phase 2b open-label extension study NCT04109313 AAD 临床2期 慢性荨麻疹 194 Remibrutinib 100mg b.i.d. ISS7(Week 1) = -6.45 Point ( 5.51) 积极 2024-03-08 Novartis Pharmaceuticals Corp. https://eposters.aad.org/archives/AM2024/53683 https://synapse.zhihuiya.com/clinical-result-detail/aa9ea4aede08325e8eae5aa2e3a54d85 Remibrutinib improves hive severity in patients with chronic spontaneous urticaria: 52-week results from a Phase 2b extension study NCT04109313 AAD 临床2期 慢性荨麻疹 194 Remibrutinib 100mg b.i.d HSS7(Week 1) = -8.32 Point  积极 2024-03-08 Novartis Pharmaceuticals Corp. https://eposters.aad.org/archives/AM2024/52636 https://synapse.zhihuiya.com/clinical-result-detail/5d0242283de0ee8882552828a4858228 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 NCT04035668 Pubmed 临床2期 脊髓小脑性共济失调 - Remibrutinib 100 mg once daily ESSPRI = 0.17 Point  积极 2024-03-01 Novartis Pharmaceuticals Canada, Inc. https://pubmed.ncbi.nlm.nih.gov/37932009/ | https://doi.org/10.1136/ard-2023-224691 https://synapse.zhihuiya.com/clinical-result-detail/0a8a2aa528285d0e358494292e2e9ad0 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 NCT04035668 Pubmed 临床2期 脊髓小脑性共济失调 - Remibrutinib 100 mg twice daily ESSPRI = 0.17 Point  积极 2024-03-01 Novartis Pharmaceuticals Canada, Inc. https://pubmed.ncbi.nlm.nih.gov/37932009/ | https://doi.org/10.1136/ard-2023-224691 https://synapse.zhihuiya.com/clinical-result-detail/0a8a2aa528285d0e358494292e2e9ad0 Remibrutinib Treatment Has No Impact on Blood Counts in Patients With Chronic Spontaneous Urticaria: Results From Phase 2b 52-week Extension Study Results NCT04109313 AAAAI 临床2期 慢性荨麻疹 194 Remibrutinib 100mg twice daily blood cell counts(52-week) = erythrocytes (1012/L): 4.61±0.42 (BL) and −0.01±0.21 (CFB); leukocytes: 6.84±2.14 (BL) and −0.41±1.65 (CFB); lymphocytes: 1.95±0.62 (BL) and −0.06±0.53 (CFB); neutrophils: 4.30±1.89 (BL) and −0.47±1.67 (CFB); eosinophils: 0.18±0.14 (BL) and −0.002±0.13 (CFB); basophils: 0.05±0.03 (BL) and 0.001±0.03 (CFB); and platelets: 263.94±66.35 (BL) and −25.09±45.21 (CFB).   积极 2024-02-23 Novartis Pharmaceuticals Corp. https://www.jacionline.org/article/S0091-6749(23)01526-9/fulltext https://synapse.zhihuiya.com/clinical-result-detail/9a28d25a2aeaa480509420e5e83552a2 Remibrutinib monotherapy reduced rescue medication in chronic spontaneous urticaria patients: Findings from a Phase 2b extension study NCT03926611 AAAAI 临床2期 慢性荨麻疹 194 Remibrutinib 100 mg twice-daily Weekly rescue medication use = mean±standard deviation: 4.0±9.1; 3.9±8.9; 3.8±8.4; 4.1±9.0 [for Weeks 1–4] vs. 8.5±10.9 [baseline]). number of tablets  - 2024-02-23 Novartis Pharmaceuticals Canada, Inc. https://www.jacionline.org/article/S0091-6749(23)01534-8/fulltext https://synapse.zhihuiya.com/clinical-result-detail/525e2a528e24e2e8a8e0e20532ad9852 Time to Relapse During Treatment-Free Follow-Up Without Remibrutinib in Patients With Chronic Spontaneous Urticaria: Subgroup Analysis By Baseline Immunoglobulin-E Levels and Chronic Urticaria Index Status From a Phase 2b Extension Study - AAAAI N/A 慢性荨麻疹 - Remibrutinib 首次复发时间 = 27 Week  - 2024-02-23 Novartis Ireland Ltd. | Novartis Pharma AG https://www.jacionline.org/article/S0091-6749(23)02343-6/fulltext https://synapse.zhihuiya.com/clinical-result-detail/55043de5da202a2e5ee88ed32ee22523 Time to Relapse During Treatment-Free Follow-Up Without Remibrutinib in Patients With Chronic Spontaneous Urticaria: Subgroup Analysis By Baseline Immunoglobulin-E Levels and Chronic Urticaria Index Status From a Phase 2b Extension Study - AAAAI N/A 慢性荨麻疹 - Remibrutinib 首次复发时间 = 7 Week  - 2024-02-23 Novartis Ireland Ltd. | Novartis Pharma AG https://www.jacionline.org/article/S0091-6749(23)02343-6/fulltext https://synapse.zhihuiya.com/clinical-result-detail/55043de5da202a2e5ee88ed32ee22523 Remibrutinib Treatment Did Not Impact Total Serum Immunoglobulin Levels or Infection Rates in Patients With Chronic Spontaneous Urticaria: Phase 2b Study Results NCT03926611 AAAAI 临床2期 慢性荨麻疹 309 Remibrutinib 10/35/100mg once daily EAIR for infections = 107.7 per 100 patient-years  积极 2024-02-23 Novartis Pharmaceuticals Canada, Inc. https://www.jacionline.org/article/S0091-6749(23)01539-7/fulltext https://synapse.zhihuiya.com/clinical-result-detail/203e25a052d2e92d2e4584a444e28aea Remibrutinib Treatment Did Not Impact Total Serum Immunoglobulin Levels or Infection Rates in Patients With Chronic Spontaneous Urticaria: Phase 2b Study Results NCT03926611 AAAAI 临床2期 慢性荨麻疹 309 Remibrutinib 10/25/100mg twice daily EAIR for infections = 107.7 per 100 patient-years  积极 2024-02-23 Novartis Pharmaceuticals Canada, Inc. https://www.jacionline.org/article/S0091-6749(23)01539-7/fulltext https://synapse.zhihuiya.com/clinical-result-detail/203e25a052d2e92d2e4584a444e28aea Efficacy of Remibrutinib in Patients With Chronic Spontaneous Urticaria With or Without Prior Exposure to Biologics in the Phase 3 REMIX-1 and REMIX-2 Studies - AAAAI N/A 慢性荨麻疹 - Remibrutinib 25 mg twice daily UAS7=0 = 32.1 %  - 2024-02-23 - https://www.jacionline.org/article/S0091-6749(23)02374-6/fulltext https://synapse.zhihuiya.com/clinical-result-detail/dd289382a5aae349eea5ad8e58a55225 Efficacy of Remibrutinib in Patients With Chronic Spontaneous Urticaria With or Without Prior Exposure to Biologics in the Phase 3 REMIX-1 and REMIX-2 Studies - AAAAI N/A 慢性荨麻疹 - Placebo UAS7=0 = 8.2 %  - 2024-02-23 - https://www.jacionline.org/article/S0091-6749(23)02374-6/fulltext https://synapse.zhihuiya.com/clinical-result-detail/dd289382a5aae349eea5ad8e58a55225 Novartis data show potential of remibrutinib as an oral treatment for chronic spontaneous urticaria providing significant symptom improvement as early as Week 2 NCT05032157 | NCT05030311 GlobeNewswire 临床3期 慢性荨麻疹 462 remibrutinib(REMIX-1) UAS7 = -20.1 Point (SE, 0.7) 达到 积极 2023-11-09 Novartis Pharmaceuticals Corp. https://www.globenewswire.com/news-release/2023/11/09/2777581/0/en/Novartis-data-show-potential-of-remibrutinib-as-an-oral-treatment-for-chronic-spontaneous-urticaria-providing-significant-symptom-improvement-as-early-as-Week-2.html https://synapse.zhihuiya.com/clinical-result-detail/20442e2922924354a94a0800a2da0a2a Novartis data show potential of remibrutinib as an oral treatment for chronic spontaneous urticaria providing significant symptom improvement as early as Week 2 NCT05032157 | NCT05030311 GlobeNewswire 临床3期 慢性荨麻疹 462 Placebo(REMIX-1) UAS7 = -13.8 Point (SE, 1.0) 达到 积极 2023-11-09 Novartis Pharmaceuticals Corp. https://www.globenewswire.com/news-release/2023/11/09/2777581/0/en/Novartis-data-show-potential-of-remibrutinib-as-an-oral-treatment-for-chronic-spontaneous-urticaria-providing-significant-symptom-improvement-as-early-as-Week-2.html https://synapse.zhihuiya.com/clinical-result-detail/20442e2922924354a94a0800a2da0a2a REMIBRUTINIB TREATMENT HAS NO IMPACT ON BLOOD COUNTS IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA NCT03926611 ACAAI 临床2期 慢性荨麻疹 309 Remibrutinib 10mg q.d. Basophils = 0.04 10^9/L ( 0.02) 积极 2023-11-09 Novartis Pharmaceuticals Canada, Inc. https://www.annallergy.org/article/S1081-1206(23)00726-3/fulltext https://synapse.zhihuiya.com/clinical-result-detail/3425402ad2e28e223ee54394d32eaa08 REMIBRUTINIB TREATMENT HAS NO IMPACT ON BLOOD COUNTS IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA NCT03926611 ACAAI 临床2期 慢性荨麻疹 309 Remibrutinib 35mg q.d. Basophils = 0.04 10^9/L ( 0.02) 积极 2023-11-09 Novartis Pharmaceuticals Canada, Inc. https://www.annallergy.org/article/S1081-1206(23)00726-3/fulltext https://synapse.zhihuiya.com/clinical-result-detail/3425402ad2e28e223ee54394d32eaa08 Remibrutinib ( LOU064 ) treatment decreases disease activity in patients with chronic spontaneous urticaria: Post hoc analysis from the Phase 2b study NCT03926611 EADV 临床2期 慢性荨麻疹 311 Remibrutinib 10 mg once daily UAS7 severity bands shift = 81.0 %  积极 2023-10-11 Novartis Pharmaceuticals Canada, Inc. https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Urticaria.pdf https://synapse.zhihuiya.com/clinical-result-detail/00e5eade8a98094e2ae948a25a04ea22 Remibrutinib ( LOU064 ) treatment decreases disease activity in patients with chronic spontaneous urticaria: Post hoc analysis from the Phase 2b study NCT03926611 EADV 临床2期 慢性荨麻疹 311 Remibrutinib 35 mg once daily UAS7 severity bands shift = 81.6 %  积极 2023-10-11 Novartis Pharmaceuticals Canada, Inc. https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Urticaria.pdf https://synapse.zhihuiya.com/clinical-result-detail/00e5eade8a98094e2ae948a25a04ea22 Remibrutinib provides fast and clinically important improvement of CSU disease activity: Post-hoc analysis from the Phase 2b study NCT03926611 EADV 临床2期 慢性荨麻疹 309 Remibrutinib 10 mg once daily Early MID-UAS7 = 64.4 %  - 2023-10-11 Novartis Pharmaceuticals Canada, Inc. https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Urticaria.pdf https://synapse.zhihuiya.com/clinical-result-detail/a80842e43925385aa5d8923552da9d84 Remibrutinib provides fast and clinically important improvement of CSU disease activity: Post-hoc analysis from the Phase 2b study NCT03926611 EADV 临床2期 慢性荨麻疹 309 Remibrutinib 35 mg once daily Early MID-UAS7 = 83.7 %  - 2023-10-11 Novartis Pharmaceuticals Canada, Inc. https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Urticaria.pdf https://synapse.zhihuiya.com/clinical-result-detail/a80842e43925385aa5d8923552da9d84 An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in CLOU064A2201 NCT04109313 CTgov 临床2期 慢性荨麻疹 229 CLOU064A2201+LOU064(Treated Cohort) AE = 139 Pts  - 2023-09-29 Novartis Pharmaceuticals Corp. https://clinicaltrials.gov/ct2/show/results/NCT04109313 https://synapse.zhihuiya.com/clinical-result-detail/da2a44a082dd8e529a20593255e25d20 An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in CLOU064A2201 NCT04109313 CTgov 临床2期 慢性荨麻疹 229 CLOU064A2201(Treatment-free Cohort (Observational Period)) 其他（不包括严重）不良反应 = 0 Pts  - 2023-09-29 Novartis Pharmaceuticals Corp. https://clinicaltrials.gov/ct2/show/results/NCT04109313 https://synapse.zhihuiya.com/clinical-result-detail/da2a44a082dd8e529a20593255e25d20 Novartis remibrutinib Phase III trials met their primary endpoints and showed rapid symptom control in chronic spontaneous urticaria NCT05032157 | NCT05030311 Corporate Publications 临床3期 慢性荨麻疹 925 remibrutinib UAS7(12 Week) = Both Phase III studies met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at Week 12, demonstrating clinically meaningful and statistically significant improvements in disease activity. The studies will continue until Week 52. Remibrutinib also demonstrated a rapid onset of action as illustrated by the improvement of UAS7 at Week 2 in the REMIX-1 and REMIX-2 studies.   达到 积极 2023-08-09 Novartis Pharmaceuticals Corp. https://www.novartis.com/news/media-releases/novartis-remibrutinib-phase-iii-trials-met-their-primary-endpoints-and-showed-rapid-symptom-control-chronic-spontaneous-urticaria https://synapse.zhihuiya.com/clinical-result-detail/adead5d2d55d5d02a8ae3802e008ea58 Novartis remibrutinib Phase III trials met their primary endpoints and showed rapid symptom control in chronic spontaneous urticaria NCT05032157 | NCT05030311 Corporate Publications 临床3期 慢性荨麻疹 925 placebo UAS7(12 Week) = Both Phase III studies met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at Week 12, demonstrating clinically meaningful and statistically significant improvements in disease activity. The studies will continue until Week 52. Remibrutinib also demonstrated a rapid onset of action as illustrated by the improvement of UAS7 at Week 2 in the REMIX-1 and REMIX-2 studies.   达到 积极 2023-08-09 Novartis Pharmaceuticals Corp. https://www.novartis.com/news/media-releases/novartis-remibrutinib-phase-iii-trials-met-their-primary-endpoints-and-showed-rapid-symptom-control-chronic-spontaneous-urticaria https://synapse.zhihuiya.com/clinical-result-detail/adead5d2d55d5d02a8ae3802e008ea58 An Adaptive Phase 2 Randomized Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Multiple LOU064 Doses in Patients With Moderate to Severe Sjögren's Syndrome (LOUiSSe) NCT04035668 CTgov 临床2期 干燥综合征 73 Remibrutinib+Placebo(Remibrutinib 100 mg qd) Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Total Score at Week 24(LS Mean) = -4.70 Point  - 2022-12-20 Novartis Pharmaceuticals Canada, Inc. https://clinicaltrials.gov/ct2/show/results/NCT04035668 https://synapse.zhihuiya.com/clinical-result-detail/49254d220482e55a82828ea0892308e9 An Adaptive Phase 2 Randomized Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Multiple LOU064 Doses in Patients With Moderate to Severe Sjögren's Syndrome (LOUiSSe) NCT04035668 CTgov 临床2期 干燥综合征 73 Remibrutinib(Remibrutinib 100 mg Bid) Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Total Score at Week 24(LS Mean) = -3.70 Point  - 2022-12-20 Novartis Pharmaceuticals Canada, Inc. https://clinicaltrials.gov/ct2/show/results/NCT04035668 https://synapse.zhihuiya.com/clinical-result-detail/49254d220482e55a82828ea0892308e9 Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria NCT03926611 Pubmed 临床2期 慢性荨麻疹 311 Remibrutinib 10 mg once daily UAS7 = -19.1 Point  积极 2022-09-09 Novartis Pharmaceuticals Canada, Inc. https://pubmed.ncbi.nlm.nih.gov/36096203/ https://synapse.zhihuiya.com/clinical-result-detail/235ede0529822e2292052535822459e2 Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria NCT03926611 Pubmed 临床2期 慢性荨麻疹 311 Remibrutinib 35 mg once daily UAS7 = -19.1 Point  积极 2022-09-09 Novartis Pharmaceuticals Canada, Inc. https://pubmed.ncbi.nlm.nih.gov/36096203/ https://synapse.zhihuiya.com/clinical-result-detail/235ede0529822e2292052535822459e2 Remibrutinib (LOU064) treatment improves quality of life in patients with chronic spontaneous urticaria - EADV 临床2期 慢性荨麻疹 309 Remibrutinib 10 mg qd DLQI=0-1 = 34.1 %  - 2022-09-07 - https://drive.google.com/file/d/1zE0z38ZlhgfeHWmkL2Gs8TBHykIlnjbn/view?usp=share_link https://synapse.zhihuiya.com/clinical-result-detail/4022ad280e58228d8a2d8502e8d208e5 Remibrutinib (LOU064) treatment improves quality of life in patients with chronic spontaneous urticaria - EADV 临床2期 慢性荨麻疹 309 Remibrutinib 35 mg qd DLQI=0-1 = 40.9 %  - 2022-09-07 - https://drive.google.com/file/d/1zE0z38ZlhgfeHWmkL2Gs8TBHykIlnjbn/view?usp=share_link https://synapse.zhihuiya.com/clinical-result-detail/4022ad280e58228d8a2d8502e8d208e5 Remibrutinib demonstrates faster time to complete urticaria control in patients with chronic spontaneous urticaria compared with placebo NCT03926611 EADV 临床2期 慢性荨麻疹 311 Remibrutinib 10 mg q.d. Time to first UAS7=0 = shortest Week  积极 2022-09-07 Novartis Pharmaceuticals Canada, Inc. https://drive.google.com/file/d/1zE0z38ZlhgfeHWmkL2Gs8TBHykIlnjbn/view?usp=share_link https://synapse.zhihuiya.com/clinical-result-detail/d2832432aae382a522282a99a288de00 Remibrutinib demonstrates faster time to complete urticaria control in patients with chronic spontaneous urticaria compared with placebo NCT03926611 EADV 临床2期 慢性荨麻疹 311 Remibrutinib 35 mg q.d. Time to first UAS7=0 = 12 weeks Week  积极 2022-09-07 Novartis Pharmaceuticals Canada, Inc. https://drive.google.com/file/d/1zE0z38ZlhgfeHWmkL2Gs8TBHykIlnjbn/view?usp=share_link https://synapse.zhihuiya.com/clinical-result-detail/d2832432aae382a522282a99a288de00 Remibrutinib Treatment Improves Quality of Life in Patients with Chronic Spontaneous Urticaria - AAAAI 临床2期 慢性荨麻疹 309 Remibrutinib 10mg q.d. DLQI=0-1 at Week 12 = 34.1 %  - 2022-02-01 Novartis Ireland Ltd. | Novartis Pharma AG https://www.jacionline.org/article/S0091-6749(21)02412-X/fulltext https://synapse.zhihuiya.com/clinical-result-detail/348255a550dae3aa8e9e42a432298252 Remibrutinib Treatment Improves Quality of Life in Patients with Chronic Spontaneous Urticaria - AAAAI 临床2期 慢性荨麻疹 309 Remibrutinib 35mg q.d. DLQI=0-1 at Week 12 = 40.9 %  - 2022-02-01 Novartis Ireland Ltd. | Novartis Pharma AG https://www.jacionline.org/article/S0091-6749(21)02412-X/fulltext https://synapse.zhihuiya.com/clinical-result-detail/348255a550dae3aa8e9e42a432298252 A Randomized, Subject- and Investigator-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of LOU064 in Patients With Inadequately Controlled Asthma NCT03944707 CTgov 临床2期 哮喘 76 LOU064 100 mg(LOU064) Change From Baseline in Pre-dose FEV1 at Week 12(Mean) = 0.105 L  - 2021-04-27 Novartis Pharmaceuticals Corp. https://clinicaltrials.gov/ct2/show/results/NCT03944707 https://synapse.zhihuiya.com/clinical-result-detail/a82338842e9e25328d22d9295ad2d8e2 A Randomized, Subject- and Investigator-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of LOU064 in Patients With Inadequately Controlled Asthma NCT03944707 CTgov 临床2期 哮喘 76 Placebo(Placebo) Change From Baseline in Pre-dose FEV1 at Week 12(Mean) = 0.075 L  - 2021-04-27 Novartis Pharmaceuticals Corp. https://clinicaltrials.gov/ct2/show/results/NCT03944707 https://synapse.zhihuiya.com/clinical-result-detail/a82338842e9e25328d22d9295ad2d8e2 12、转化医学 研究 亮点 主题 期刊/会议 出版日期 适应症 机构 Remibrutinib Showed a Favorable Safety Profile and Sustained Efficacy in Japanese Patients with Chronic Spontaneous Urticaria Over 52 Weeks **总结：**  瑞玛布鲁替尼（Remibrutinib）是一种口服高选择性BTK抑制剂，在针对日本慢性自发性荨麻疹（CSU）患者的52周开放标签单臂试验（BISCUIT研究）中显示出良好的安全性和持续疗效。71名患者（平均年龄43.5岁）接受25mg每日两次的附加治疗，87.3%报告了≥1例不良事件（AE），均为轻中度，最常见为COVID-19（19.7%）和头痛（12.7%）。无药物相关严重AE或死亡。疗效方面，第12周时患者每周荨麻疹活动评分（UAS7）和瘙痒/风团评分较基线显著改善（分别降低18.1、8.0和10.1分），且疗效从第1周持续至第52周。52周时，53.6%患者疾病控制良好（UAS7≤6），30.4%症状完全消失（UAS7=0）。结论：瑞玛布鲁替尼安全性良好，能快速持久缓解CSU症状，支持其作为日本CSU患者的潜在口服BTK抑制剂疗法。  **关键词：** 慢性自发性荨麻疹；BTK抑制剂；长期安全性；持续疗效 3期临床研究 Dermatol Ther (Heidelb) 2026-02-19 慢性荨麻疹 Novartis Pharmaceuticals Corp. Systemic Treatments for Chronic Spontaneous Urticaria: Anti-IgE and Beyond - 3期临床研究 J Allergy Clin Immunol Pract 2026-02-01 慢性荨麻疹 Section of Rheumatology, Allergy and Immunology, Department of Medicine, Yale School of Medicine, New Haven, Conn. Remibrutinib in chronic spontaneous urticaria: 52-week results from two phase 3 studies - 3期临床研究 J Allergy Clin Immunol 2026-01-01 慢性荨麻疹 Novartis Pharma KK | Allergy & Clinical Immunology Associates, Inc. | Novartis Ireland Ltd. | Novartis Pharma AG | Novartis (China) Biomedical Research, Shanghai, China. | Novartis Pharmaceuticals Corporation, East Hanover, NJ. | Allergy, Asthma, and Immunology Associates PC, Lincoln, Neb. | Department of Dermatology, Hospital del Mar and Research Institute, Universitat Pompeu Fabra, Barcelona, Spain. Electronic address: anamariagimenezarnau@gmail.com. A new era in chronic spontaneous urticaria: FDA approval of the oral BTK inhibitor remibrutinib - 真实世界研究 Ann Med Surg (Lond) 2025-11-24 慢性荨麻疹 Department of Medicine, Shaikh Khalifa Bin Zayed Al Nahyan Medical and Dental College, Lahore, Pakistan Emerging IgE and non-IgE targeted therapies for chronic urticaria - 3期临床研究 Ann Allergy Asthma Immunol 2025-11-01 慢性荨麻疹 Division of Allergy and Immunology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois | Center for Human Immunobiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois. Next generation Bruton's tyrosine kinase inhibitors – characterization of in vitro potency and selectivity - 药物发现/临床前 Eur J Pharmacol 2025-09-01 non-oncologic indications Novartis Institutes of Biomedical Research Biologic and small molecule therapies in chronic spontaneous urticaria: an update - 3期临床研究 Curr Opin Allergy Clin Immunol 2025-08-01 慢性荨麻疹 Department of Dermatology and Allergy, Comprehensive Allergy Center, Hannover Medical School, Hannover, Germany. Evaluating remibrutinib in the treatment of chronic spontaneous urticaria - 2/3期临床研究 Immunotherapy 2025-06-02 慢性荨麻疹 Clinical State Hospital 2 in Rzeszow Remibrutinib Exposure in Cerebrospinal Fluid: Insights from a Study in Healthy Participants (P12-1.003) 本研究旨在调查健康参与者脑脊液中雷米布替尼的暴露情况。研究结果表明，所有接受雷米布替尼的参与者的脑脊液样本中成功检测到雷米布替尼，而安慰剂组的样本中未检测到雷米布替尼。这表明雷米布替尼可能在中枢神经系统产生药理效应，对多发性硬化等疾病可能具有潜在益处。雷米布替尼是一种高选择性、高效的口服布鲁顿酪氨酸激酶抑制剂，正在进行两项重要的三期临床试验，以评估其作为多发性硬化新治疗药物的潜在疗效。这是首个评估人类脑脊液中雷米布替尼暴露情况的研究。 3期临床研究 AAN 2025 2025-04-07 复发性多发性硬化 Novartis Institutes of Biomedical Research | Novartis Pharma AG Comparing novel treatments in chronic spontaneous urticaria: A critical appraisal of Bruton's tyrosine kinase inhibitors versus anti‐cytokine biologics in clinical trials - 2期临床研究 Clin Transl Allergy 2025-03-27 慢性荨麻疹 Medical Correspondence Unit | Lydia Becker Institute of Immunology and Inflammation, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK Update on the Treatment of Chronic Spontaneous Urticaria - 3期临床研究 Drugs 2025-03-12 慢性荨麻疹 Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany. pavel.kolkhir@charite.de. | Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 27, 12203, Berlin, Germany. pavel.kolkhir@charite.de. | Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany. Remibrutinib in patients with moderate to severe hidradenitis suppurativa: Patient reported outcomes from a randomized, phase 2, double-blind, placebo-controlled platform study **总结：**  Remibrutinib是一种高选择性口服BTK抑制剂，在治疗中重度化脓性汗腺炎（HS）的II期随机双盲对照试验中（NCT03827798），患者被分为25mg（N=33）、100mg（N=33）和安慰剂组（N=11），每日两次给药16周。结果显示，与安慰剂相比，25mg和100mg组的HiSCR缓解率更高（69.7%和48.5% vs. 32.7%）。此外，患者报告结局显示：  1. **皮肤疼痛和瘙痒改善**：第16周时，25mg和100mg组的NRS30应答率均高于安慰剂（疼痛：44.4%/57.1% vs. 30.4%；瘙痒：78.6%/56.0% vs. 44.4%）。  2. **生活质量提升**：DLQI评分显示，25mg和100mg组生活质量受“极大影响”的患者比例显著降低（30.3%/24.2% vs. 36.7%），基线时为75.8%/63.6% vs. 61.2%。  **结论**：Remibrutinib不仅提高HiSCR率，还能显著改善皮肤疼痛、瘙痒及生活质量，提示BTK抑制可能是HS的潜在治疗靶点。   2期临床研究 AAD 2025 2025-03-07 化脓性汗腺炎 Novartis Pharmaceuticals Corp. Improvements in Itch and Hive Symptoms With Remibrutinib as Early as Week 1 in Patients With Chronic Spontaneous Urticaria (CSU) in REMIX-1/-2 **总结：**  Remibrutinib是一种口服高选择性Bruton酪氨酸激酶抑制剂，在两项多中心、随机、双盲、安慰剂对照的3期试验（REMIX-1/-2）中评估其对H1抗组胺药控制不佳的慢性自发性荨麻疹（CSU）患者的疗效。患者以2:1比例随机接受remibrutinib（25 mg，每日两次）或安慰剂治疗24周，随后全部转为开放标签remibrutinib治疗28周。  结果显示，remibrutinib组在瘙痒严重程度评分（ISS7）和荨麻疹严重程度评分（HSS7）上较安慰剂组显著改善（所有时间点P<0.001）：  - **第1周**：ISS7改善（REMIX-1: -5.2 vs -2.1；REMIX-2: -5.0 vs -1.4），HSS7改善（REMIX-1: -6.0 vs -1.9；REMIX-2: -6.3 vs -1.5）。  - **第12周和第24周**：疗效持续增强（如REMIX-1 ISS7第24周：-9.8 vs -8.0）。  - **第52周**：疗效维持稳定，且初始接受安慰剂的患者在24周后转为remibrutinib治疗时疗效与早期治疗组相当。  结论：remibrutinib在CSU患者中早期（第1周）即快速显著改善症状，疗效持续至52周，安全性良好。 3期临床研究 AAD 2025 2025-03-07 慢性荨麻疹 - Effect of Remibrutinib on Sleep and Daily Activities in Patients With Chronic Spontaneous Urticaria (CSU) up to Week 52 in the REMIX-1/-2 studies **摘要：**  Remibrutinib是一种口服高选择性BTK抑制剂，用于治疗慢性自发性荨麻疹（CSU）。REMIX-1/-2为多中心、随机、双盲III期研究，评估其对患者睡眠及日常活动的影响。患者按2:1随机接受remibrutinib（25mg，每日两次）或安慰剂治疗24周，随后全部转为remibrutinib开放标签治疗28周（共52周）。  **关键结果：**  1. **睡眠改善（SIS7评分）**：     - 治疗组基线SIS7评分（REMIX-1/2分别为12.7/11.8）显著降低，第1周即显现优势（治疗组vs安慰剂：REMIX-1 -5.2±5.2 vs -2.3±4.1；REMIX-2 -4.4±4.4 vs -1.5±4.1），持续至52周（最终降幅约-9.0至-9.9）。     - 第24周时，58.9%（REMIX-1）和58.2%（REMIX-2）治疗组患者实现SIS7=0（完全无干扰），显著高于安慰剂组（44.2%/41.2%）。  2. **活动干扰（AIS7评分）**：     - 趋势与SIS7一致，治疗组改善更显著且持久。  **结论：**  Remibrutinib能快速（1周内）并持续改善CSU患者的睡眠及日常活动干扰，疗效优于安慰剂，长期（52周）维持效果显著。   3期临床研究 AAD 2025 2025-03-07 慢性荨麻疹 - Remibrutinib in Chronic Spontaneous Urticaria - 3期临床研究 N Engl J Med 2025-03-06 慢性荨麻疹 Novartis Pharmaceuticals Corp. A Post-hoc Analysis of Two Phase 2 Randomized Controlled Trials in Patients with Active Sjogren’s Disease Exploring the Novel Composite Endpoint Sjögren’s Tool for Assessing Response (STAR) - 2期临床研究 ACR 2024 2024-11-10 - Novartis Pharmaceuticals Canada, Inc. NO CLINICALLY MEANINGFUL IMPACT OF REMIBRUTINIB ON IMMUNOGLOBULIN LEVELS OR INFECTIONS IN CHRONIC SPONTANEOUS URTICARIA 在慢性特发性荨麻疹患者中，雷米布替尼对免疫球蛋白水平或感染没有临床意义的影响。雷米布替尼是一种口服高选择性布鲁顿酪氨酸激酶（BTK）抑制剂。研究分析了雷米布替尼对慢性特发性荨麻疹（CSU）患者总免疫球蛋白水平和感染率的影响。研究结果显示，雷米布替尼对免疫球蛋白水平无显著影响，感染率与安慰剂组相当，并且随着长期治疗并未增加。 3期临床研究 ACAAI 2024 2024-10-24 慢性荨麻疹 - REMIX-1/-2: EARLY SYMPTOM IMPROVEMENTS WITH REMIBRUTINIB IN CHRONIC SPONTANEOUS URTICARIA FROM WEEK 1 - 3期临床研究 ACAAI 2024 2024-10-24 慢性荨麻疹 Hiroshima,Japan | Baltimore,MD | Basel,Switzerland Remibrutinib, a BTKi, has no impact on serum urticaria 研究显示，雷米布替尼（Remibrutinib）作为一种高选择性、强效的布鲁顿酪氨酸激酶抑制剂（BTKi），对慢性特发性荨麻疹（CSU）患者的血清免疫球蛋白水平没有影响。研究结果表明，在为期52周的雷米布替尼治疗中，包括100mg两次每日剂量，患者的总血清免疫球蛋白水平未发生显著变化。这一结论对于雷米布替尼在多发性硬化症（MS）临床试验中使用的100mg两次每日剂量具有重要指导意义。 2期临床研究 EAN 2024 2024-06-28 血清病 Novartis Pharmaceuticals Corp. BTK signaling—a crucial link in the pathophysiology of chronic spontaneous urticaria - 致病机理 J Allergy Clin Immunol 2024-05-01 慢性荨麻疹 Department of Internal Medicine, Allergy and Immunology Section, University of Cincinnati College of Medicine, Cincinnati, Ohio. | Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany. The Bruton’s Tyrosine Kinase Inhibitor Remibrutinib Exhibits No Impact on Serum Immunoglobulin Levels: Insights from Chronic Spontaneous Urticaria (P10-6.018) 该研究旨在评估布氏酪氨酸激酶抑制剂雷米布替尼对慢性特发性荨麻疹（CSU）患者血清免疫球蛋白（Ig）水平的影响。研究结果显示，在52周的长期治疗中，雷米布替尼对CSU患者的总Ig水平没有影响，包括使用100mg b.i.d.的剂量。这一发现对于雷米布替尼在多发性硬化症（MS）临床试验中的应用具有重要意义。 2期临床研究 AAN 2024 2024-04-09 慢性荨麻疹 Novartis Pharmaceuticals Corp. Safety of Remibrutinib Across Immune-mediated Diseases Supports Development in Multiple Sclerosis (P8-6.015) 本研究旨在报告使用来自慢性自发性荨麻疹（CSU）、干燥综合征（SjS）和哮喘的已完成2期临床试验的汇总数据，以评估remibrutinib的综合安全性。研究结果显示，任何剂量的remibrutinib患者的不良事件发生率为260.8，100毫克亚组为224.8。最常见的不良事件包括感染和寄生虫感染，皮肤/皮下组织疾病，胃肠道疾病，神经系统疾病和肌肉骨骼疾病。总体而言，remibrutinib的安全性与安慰剂相似，支持其在多发性硬化等免疫介导疾病的发展。 2期临床研究 AAN 2024 2024-04-09 - University of Toronto | Novartis Institutes for Biomedical Research, Inc. | Novartis Pharmaceuticals Canada, Inc. | Novartis Pharma AG Remibrutinib provides sustained improvement in itch severity in patients with chronic spontaneous urticaria: Phase 2b open-label extension study **总结：**  Remibrutinib（一种高选择性口服布鲁顿酪氨酸激酶抑制剂）在慢性自发性荨麻疹（CSU）患者的瘙痒症状改善中展现出快速且持久的疗效。一项为期52周的开放标签2b期扩展研究（NCT04109313）纳入194例基线UAS7评分≥16的CSU患者，给予remibrutinib 100mg每日两次治疗。结果显示，患者瘙痒严重程度评分（ISS7，范围0-21）从基线12.8±4.55显著下降：第1周（-6.45±5.51）、第2周（-7.7±6.42）、第4周（-7.9±6.64）、第12周（-8.8±6.30）至第52周（-9.9±5.62）。这表明remibrutinib在治疗首周即可快速缓解瘙痒，且疗效持续维持52周，显著改善CSU患者的生活质量。   2期临床研究 AAD 2024 2024-03-08 慢性荨麻疹 Novartis Pharmaceuticals Corp. Time to first relapse during treatment-free follow-up without remibrutinib in patients with chronic spontaneous urticaria (CSU): subgroup analysis by baseline disease status and CSU duration from a Phase 2b extension study **总结：**  本研究为一项IIb期扩展试验（NCT04109313），评估高选择性口服BTK抑制剂remibrutinib治疗慢性自发性荨麻疹（CSU）后停药随访期的首次复发时间（定义为UAS7≥16）。纳入完成核心研究（NCT03926611）且基线UAS7≥16的患者，接受remibrutinib 100mg每日两次治疗52周。治疗结束时UAS7≤6的患者进入16周随访，观察复发情况。  **结果：**  98例患者进入随访，41例（41.8%）复发，其中34.7%在停药4周内复发。按基线疾病严重程度分组，中度和重度患者4周内复发率分别为30.0%和41.9%；按病程分组（≤1年、>1~≤3年、>3~≤5年、>5年），复发率分别为55.6%、35.5%、46.7%和25.6%。Kaplan-Meier分析显示随访结束时累计复发率为43.9%。  **结论：**  停药后复发多发生于前4周内，重度患者复发率高于中度患者，但病程长短对复发无显著影响。提示疾病严重程度可能为停药后复发风险的关键因素。   2期临床研究 AAD 2024 2024-03-08 慢性荨麻疹 Novartis Pharmaceuticals Corp. Remibrutinib reduces CSU symptoms and rescue medication use in patients with chronic spontaneous urticaria despite absence of background medication - 2期临床研究 AAD 2024 2024-03-08 慢性荨麻疹 - Remibrutinib improves hive severity in patients with chronic spontaneous urticaria: 52-week results from a Phase 2b extension study **总结：瑞玛布鲁替尼（Remibrutinib）在慢性自发性荨麻疹（CSU）患者中的长期疗效与安全性**  瑞玛布鲁替尼是一种高选择性口服Bruton酪氨酸激酶抑制剂。在一项为期52周的2b期开放标签扩展研究（NCT04109313）中，194名基线UAS7评分≥16的CSU患者接受100mg每日两次治疗。结果显示，患者平均荨麻疹严重程度评分（HSS7）从基线15.10±5.24迅速下降，治疗第1周即降低8.32±6.58，并持续改善至第52周（降幅达11.89±6.29）。  该研究表明，瑞玛布鲁替尼能快速（1周内起效）且持久（52周）缓解CSU患者的荨麻疹症状，安全性良好，支持其作为CSU的长期治疗选择。   2期临床研究 AAD 2024 2024-03-08 慢性荨麻疹 Novartis Pharmaceuticals Corp. 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 - 2期临床研究 Ann Rheum Dis 2024-03-01 Crouzon综合征伴黑棘皮症 Novartis Pharmaceuticals Canada, Inc. Remibrutinib monotherapy reduced rescue medication in chronic spontaneous urticaria patients: Findings from a Phase 2b extension study 该研究报告了在慢性特发性荨麻疹（CSU）患者中，雷米布替尼单药治疗减少了救助药物的使用。在扩展研究中，194名完成核心研究并在扩展研究开始时具有每周荨麻疹活动评分（UAS7）≥16的患者接受雷米布替尼100毫克口服，连续52周。结果显示，在前4周内，雷米布替尼单药治疗减少了救助药物的使用，这种效果与同时服用标准剂量的H1-抗组胺药物时相似。因此，雷米布替尼在单药治疗时与同时服用标准剂量的H1-抗组胺药物相比，同样能减少H1-抗组胺药物（救助药物）的每周使用量。 2期临床研究 AAAAI 2024 2024-02-23 慢性荨麻疹 Novartis Pharmaceuticals Corp. Remibrutinib Treatment Has No Impact on Blood Counts in Patients With Chronic Spontaneous Urticaria: Results From Phase 2b 52-week Extension Study Results 本研究旨在评估雷米布替尼（LOU064）对慢性特发性荨麻疹患者血细胞计数的影响。研究结果显示，52周的长期治疗中，雷米布替尼未引起患者红细胞、白细胞、淋巴细胞、中性粒细胞、嗜酸性粒细胞、嗜碱性粒细胞和血小板计数的显著变化。总体而言，雷米布替尼治疗未引起血细胞计数的显著变化，与2期核心和延长研究中观察到的良好临床安全性相一致。 2期临床研究 AAAAI 2024 2024-02-23 慢性荨麻疹 Novartis Pharmaceuticals Corp. Remibrutinib Treatment Did Not Impact Total Serum Immunoglobulin Levels or Infection Rates in Patients With Chronic Spontaneous Urticaria: Phase 2b Study Results 该研究报告了在慢性特发性荨麻疹（CSU）患者中使用雷米布替尼治疗对总血清免疫球蛋白（Ig）水平和感染率的影响。研究结果显示，雷米布替尼在核心研究和52周延长研究中未对CSU患者的总血清Ig水平产生影响。长期使用雷米布替尼未增加感染率，并且与核心研究中任何雷米布替尼/安慰剂组相比保持可比性。这表明雷米布替尼在CSU患者中具有良好的安全性和耐受性。 2期临床研究 AAAAI 2024 2024-02-23 慢性荨麻疹 Novartis Pharmaceuticals Corp. Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks Remibrutinib是一种口服高选择性Bruton酪氨酸激酶抑制剂，对慢性特发性荨麻疹（CSU）患者具有快速的疾病控制作用。在52周内，Remibrutinib表现出良好的安全性和持久的疗效。在扩展研究中，84.3%的患者接受了Remibrutinib治疗，其安全性与核心研究相当。在4周和52周时，UAS7的平均变化分别为-17.6 ± 13.40和-21.8 ± 10.70；观察到的UAS7 = 0分别达到28.2%和55.8%，观察到的UAS7 ≤6分别达到52.7%和68.0%。总之，Remibrutinib在CSU患者中表现出持续的良好安全性和快速疗效。 3期临床研究 Pubmed 2024-02-01 慢性荨麻疹 McMaster University | IQVIA Holdings, Inc. | The Clinical Research Center | Novartis Ireland Ltd. | Allergy & Asthma Associates of California | Novartis Pharma AG ANALYSIS OF SAFETY DATA OF REMIBRUTINIB FROM COMPLETED PHASE 2 STUDIES IN INFLAMMATORY IMMUNE-MEDIATED DISEASES 本文总结了Remibrutinib（LOU064）在完成的2期临床研究中的安全数据分析，包括长期治疗参与者。研究涉及慢性自发性荨麻疹（CSU）、干燥综合征（SjS）、哮喘等免疫介导疾病。结果显示，Remibrutinib的不良事件（AEs）与安慰剂相当，主要为感染（主要为上呼吸道感染）。特别关注的不良事件（AESI）主要为轻度至中度，随着长期暴露而不增加，包括感染、瘀点/紫癜事件和罕见的细胞减少事件。在生命体征和实验室参数方面未发现新的安全问题。这一分析将进一步提供Remibrutinib在其他炎症免疫介导疾病中的安全性和耐受性信息，补充当前对CSU中Remibrutinib安全性和耐受性的证据。 2期临床研究 ACAAI 2023 2023-11-09 - Hiroshima Cryo-Preservation Service Co. Ltd. | Baltimore REMIBRUTINIB PROVIDES FAST AND CLINICALLY IMPORTANT IMPROVEMENT OF CHRONIC SPONTANEOUS URTICARIA DISEASE ACTIVITY 该研究分析了雷米布替尼在慢性特发性荨麻疹（CSU）患者中的早期疗效。结果显示，雷米布替尼能够在治疗后两周内迅速改善病情，使患者达到临床意义上的最小重要差异（MID）UAS7降低10.5分。与安慰剂相比，雷米布替尼组患者中有更高比例的人在任何时间点（77.8%–93.2% vs 59.5%）和治疗开始后两周内（64.4%–83.7% vs 23.8%）达到MID-UAS7。因此，该研究表明雷米布替尼具有快速的疗效。 2期临床研究 ACAAI 2023 2023-11-09 慢性荨麻疹 Basel - SpA | Mumbai | WalnutCreek REMIBRUTINIB TREATMENT IMPROVES HIVE SEVERITY IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA: PHASE 2B STUDY RESULTS - 2期临床研究 ACAAI 2023 2023-11-09 慢性荨麻疹 Basel - SpA | Tokyo, Inc. /Elevi/ | Hamilton Co. | LittleRock | Barcelona,Spain FAST SYMPTOM IMPROVEMENT AND FAVORABLE SAFETY PROFILE WITH REMIBRUTINIB IN CHRONIC SPONTANEOUS URTICARIA: REMIX-1/-2 STUDIES - 3期临床研究 ACAAI 2023 2023-11-09 慢性荨麻疹 Hiroshima Cryo-Preservation Service Co. Ltd. | London & Co. | Basel - SpA | NewYork-Presbyterian/Queens | 云南未知未来医药有限公司 | Berlin,Germany | Barcelona,Spain REMIBRUTINIB TREATMENT HAS NO IMPACT ON BLOOD COUNTS IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA 研究显示，雷米布替尼治疗对慢性自发性荨麻疹患者的血细胞计数没有影响。在研究中，对雷米布替尼治疗组和安慰剂组的患者进行了血细胞计数的评估，结果显示治疗组的各种血细胞计数变化均在正常范围内，与雷米布替尼在早期研究中表现出的良好安全性一致。 2期临床研究 ACAAI 2023 2023-11-09 慢性荨麻疹 Novartis Pharmaceuticals Corp. REMIBRUTINIB ACHIEVES CLINICALLY SIGNIFICANT RESPONSE IN CHRONIC SPONTANEOUS URTICARIA PATIENTS REGARDLESS OF PRIOR ORAL TREATMENTS - 2期临床研究 ACAAI 2023 2023-11-09 慢性荨麻疹 Owensboro,KY | Berlin,Germany | Barcelona,Spain | Basel,Switzerland REMIBRUTINIB DID NOT IMPACT ON TOTAL SERUM IMMUNOGLOBULIN LEVELS OF PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA - 2期临床研究 ACAAI 2023 2023-11-09 慢性荨麻疹 Basel - SpA | Tokyo, Inc. /Elevi/ | MissionViejo Remibrutinib, an oral, highly selective BTKi in development for CSU: Analysis of safety data from the completed Phase 2 studies in inflammatory immune-mediated diseases 研究分析了remibrutinib在慢性特发性荨麻疹（CSU）以及其他炎症介导的免疫性疾病中的安全数据。研究得出结论，remibrutinib在CSU患者中表现出较快的疾病控制，且其安全性和耐受性良好。研究发现，与安慰剂相比，remibrutinib引起的不良事件包括感染（主要为上呼吸道感染）与安慰剂相当。对于与长期治疗相关的严重不良事件，如出血、感染和细胞减少症，随着时间的推移未呈增加趋势。在临床数据和实验室参数（包括血液细胞计数和生化检查、肝酶等）的观察中，未发现新的安全问题。该研究结果将在大会上呈现，并有望为remibrutinib在免疫介导性炎症疾病中的安全性提供更多信息。 2期临床研究 EADV 2023 2023-10-11 - - Remibrutinib Treatment Improves Itch, Sleep and Activity in Chronic Spontaneous Urticaria Patients: Phase 2b Study Results 这项研究表明，Remibrutinib可以显著改善慢性特发性荨麻疹患者的瘙痒、睡眠和活动。Remibrutinib在短时间内（早至第2周）就展现出快速和持续的改善效果，甚至可以完全消除瘙痒，不影响睡眠和活动，而且对安慰剂组效果显著。这项研究为患有慢性特发性荨麻疹的患者提供了一个新的口服选择，对于那些即使接受第二代H1-抗组胺药物治疗仍有症状的患者来说，Remibrutinib可能是一种快速控制疾病的选择。 2期临床研究 EADV 2023 2023-10-11 - - Remibrutinib Improves Chronic Spontaneous Urticaria in Patients Irrespective of Previous Anti-IgE Treatment: Results from a Phase 2b Study 这是一项关于Remibrutinib对慢性特发性荨麻疹（CSU）患者的改善效果的研究。结论是，Remibrutinib对UAS7的改善以及达到UAS7=0和UAS7≤6的效果显著，而且不受先前抗IgE治疗的影响。需要进行更大规模的研究以确认阶段2b研究的结果。在这项研究中，对311名CSU患者进行了分层随机对照试验，结果表明，不论有无先前抗IgE治疗，Remibrutinib都显著改善了患者的症状，且没有明显差异。因此，Remibrutinib可能成为对于使用二代H1-抗组胺药无效的CSU患者的一种新治疗选择。 2期临床研究 EADV 2023 2023-10-11 慢性荨麻疹 - Remibrutinib provides fast and clinically important improvement of CSU disease activity: Post-hoc analysis from the Phase 2b study 该研究是一项后续分析，结果显示雷米布替尼治疗慢性特发性荨麻疹（CSU）疾病活动有快速和临床重要的改善。研究发现，在雷米布替尼治疗的前两周，大多数患者就达到了最小重要差异UAS7（MID-UAS7），表明雷米布替尼具有快速的疗效。雷米布替尼是一种口服高选择性布鲁顿酪氨酸激酶（BTK）抑制剂，对于接受二代H1-抗组胺药物治疗仍有症状的CSU患者提供快速疾病控制。研究结果显示，雷米布替尼在不同剂量下，与安慰剂相比，能够更快地实现MID-UAS7，且对于早期实现MID-UAS7的患者，达到UAS7=0和UAS7≤6的时间也更短。该研究结果为雷米布替尼在CSU治疗中的快速疗效提供了有力的临床证据。 2期临床研究 EADV 2023 2023-10-11 慢性荨麻疹 Novartis Pharmaceuticals Corp. Remibrutinib ( LOU064 ) treatment decreases disease activity in patients with chronic spontaneous urticaria: Post hoc analysis from the Phase 2b study 该研究是一项后续分析，显示了雷米布替尼治疗能够在2周内减少慢性特发性荨麻疹（CSU）患者的疾病活动，超过80%的患者在12周的研究期间保持了持续的疗效。雷米布替尼治疗组中有更多患者在所有测定时间点上没有疾病活动。这项研究表明，雷米布替尼对于CSU患者具有快速的疾病控制作用，尤其是对于那些尽管接受了二代H1-抗组胺药物治疗仍然有症状的患者。在雷米布替尼的临床试验中，患者的疾病活动得到了有效控制，并且具有良好的安全性。该研究对雷米布替尼治疗患者的CSU疾病活动进行了分析，结果显示在雷米布替尼治疗组中，患者的疾病活动得到了明显的改善，且持续性较好。 2期临床研究 EADV 2023 2023-10-11 慢性荨麻疹 Novartis Pharmaceuticals Corp. Remibrutinib ameliorates CNS autoimmune disease - insights from EAE - 药物发现/临床前 ECTRIMS 2023 2023-09-30 脑脊髓炎 Novartis Institutes for Biomedical Research, Inc. | Novartis Pharma AG Remibrutinib, a Novel Highly Selective and Potent BTKi in Development for MS: Analysis of Safety Data From the Completed Phase 2 Studies in Other Inflammatory Immune-Mediated Diseases Remibrutinib是一种新型的高选择性和高效的BTK抑制剂，目前正在进行第3期试验，用于治疗多发性硬化症（MS; NCT05147220/NCT05156281）。该药物在体外显示出高选择性和高效性，有潜力最小化非靶向毒性和相关不良事件（AEs）。本文分析了在慢性自发性荨麻疹（CSU）、干燥综合征（SjS）和哮喘等非MS适应症中完成的第2期研究中的安全数据，结果显示Remibrutinib的不良事件与安慰剂相当，主要为感染（主要为上呼吸道感染）。随着长期暴露，观察到的特殊不良事件包括出血、感染和细胞减少症，并未增加。迄今为止，临床数据和实验室参数未发现新的安全问题。将在大会上呈报52周开放标签延长研究的最终数据分析。 2期临床研究 ECTRIMS 2023 2023-09-30 - University of Toronto | University of Turku | Novartis Institutes for Biomedical Research, Inc. | The Brigham & Women's Hospital, Inc. | University of Münster | Novartis Pharmaceuticals Canada, Inc. | Charité - Universitätsmedizin Berlin | Novartis Pharma AG | Fraunhofer Institute for Translational Medicine and Pharmacology ITMP | Cleveland Clinic Remibrutinib inhibits effector cell activation triggered by serum from chronic urticaria patients 研究发现，Remibrutinib能够抑制慢性荨麻疹患者血清引发的效应细胞激活。研究对象包括慢性特发性荨麻疹和慢性诱发性荨麻疹患者，结果显示Remibrutinib能够抑制由患者血清引发的效应细胞脱颗粒和激活。这一发现为慢性荨麻疹的治疗提供了新的策略，尤其对于那些对常规治疗不完全控制症状的患者具有重要意义。 药物发现/临床前 WCD 2023 2023-07-04 慢性荨麻疹 Novartis Institutes for Biomedical Research, Inc. | Novartis Pharma AG | Hospital Del Mar, Imim, Universitat Pompeu Fabra. Barcelona, Spain Remibrutinib: A Novel BTKi inDevelopment for MS With a FavorableSafety Profile in Various AutoimmuneDisorders Remibrutinib是一种新型的BTKi，目前正在进行多发性硬化（MS）的3期临床试验。通过对慢性自发性荨麻疹（CSU）、干燥综合征（SjS）和哮喘的临床试验数据分析发现，Remibrutinib在各种自身免疫性疾病中具有良好的安全性。研究结果显示，在CSU患者中，Remibrutinib的安全性与核心研究中的剂量相当，最常见的不良事件是感染和皮肤、皮下、胃肠道和神经系统疾病。长期治疗期间，没有出现感染率增加的情况，其他特殊不良事件也没有发生变化。实验结果表明，Remibrutinib在2期试验和52周的开放性延长研究中（最高剂量为100 mg b.i.d.）表现出良好的安全性和耐受性，支持其在MS的3期临床试验中的发展。 2期临床研究 EAN 2023 2023-06-28 - Novartis Institutes for Biomedical Research, Inc. | Charité - Universitätsmedizin Berlin | Novartis Pharma AG | Novartis Pharmaceutical Corporation, Cambridge, MA, USA | Turku University Hospital and University of Turku, Finland REMIBRUTINIB SPECIFICALLY DOWNREGULATES MARKERS OF MEMORY B CELL SUBSETS IN SJÖGREN’S PATIENTS (SJS) IN THE LOUISSE PHASE 2 CLINICAL TRIAL 文中指出，瑞米布替尼在Sjögren综合征（SjS）患者中特异性降低了记忆B细胞亚群的标志物，这一发现来自LOUiSSe 2期临床试验。研究表明，瑞米布替尼可作为SjS治疗的有前景选择，因其能够靶向患者B细胞异常，并在临床试验中显示出良好的疗效和安全性。研究结果显示，瑞米布替尼显著地下调了与B细胞活性有关的35种蛋白质，以及与B细胞激活、分化和成熟相关的多条通路。此外，瑞米布替尼还对组织记忆B细胞亚群具有强烈的抑制作用。总体而言，瑞米布替尼的治疗效果不仅体现在B细胞通路上，同时也对改善SjS患者的病情具有重要意义。 2期临床研究 EULAR 2023 2023-05-31 骨软骨发育不良 Novartis Foundation | Charité – Universitätsmedizin Berlin | German Rheumatism Research Center Remibrutinib: A Novel BTKi in Development for MS With a Favorable Safety Profile in Various Autoimmune Disorders (P7-3.015) Remibrutinib是一种新型的BTKi，目前正在进行第三阶段试验，用于治疗多发性硬化症。该药物在自体试验中显示出良好的选择性和强效，并有潜力最小化非靶向毒性和相关不良事件。在慢性特发性荨麻疹、干燥综合症和哮喘的第二期试验和继发试验中，Remibrutinib表现出良好的安全性和耐受性，并表现出与安慰剂相当的不良事件率，没有感染率增加的情况。总之，Remibrutinib在多种自身免疫性疾病中显示出潜在的安全性和可耐受性，可以支持其用于多发性硬化症的第三阶段临床试验。 3期临床研究 AAN 2023 2023-04-25 - Novartis Institutes for Biomedical Research, Inc. | Novartis Pharma AG | Novartis Pharma AG, Basel, Switzerland; Department of Neurology, Heinrich-Heine University, Duesseldorf, Germany | Department of Rheumatology and Clinical Immunology, Charite Universitätsmedizin Berlin; DRFZ, Berlin, Germany | Joi Life Wellness Group, Atlanta, GA, USA | Novartis Pharmaceutical Corporation, Cambridge, MA, USA Remibrutinib, a Novel Bruton’s Tyrosine Kinase Inhibitor, Exhibits Improved Target Selectivity and Potency In Vitro (P8-3.003) 该研究评估了针对多发性硬化症（MS）的Bruton酪氨酸激酶抑制剂（BTKis）的选择性和效力。结果显示，remibrutinib在体外表现出更好的靶向选择性和效力，对B细胞和嗜碱性粒细胞的抑制作用较强。与其他BTKis相比，remibrutinib在人类激酶组中表现出最高的选择性，这可能会在临床疗效和安全性上产生差异。该研究对共价和可逆BTKis进行了绑定和选择性的评估，结果显示remibrutinib的IC50值最低，对B细胞的抑制作用最强。因此，remibrutinib可能成为治疗MS的有力候选药物。 药物发现/临床前 AAN 2023 2023-04-25 多发性硬化症 Novartis Institutes for Biomedical Research, Inc. | Novartis Pharma AG Remibrutinib Inhibits Neuroinflammation Driven by B Cells and Myeloid Cells in Preclinical Models of Multiple Sclerosis (P2-3.013) Remibrutinib是一种高选择性的BTK抑制剂，对多发性硬化的预临床和临床表现有希望。在实验动物模型中，Remibrutinib对B细胞驱动的EAE表现出剂量依赖的疗效，并观察到对髓样细胞和微胶质细胞的抗炎效应。Remibrutinib可能代表了多发性硬化患者的新治疗选择。研究结果显示，Remibrutinib通过选择性抑制B细胞，抑制了EAE的发病和神经功能损伤，同时还对髓样细胞和微胶质细胞具有抗炎作用。这些发现为Remibrutinib在多发性硬化治疗中的应用提供了机制和疗效的证据。 药物发现/临床前 AAN 2023 2023-04-25 多发性硬化症 Novartis Institutes for Biomedical Research, Inc. | Novartis Pharma AG Remibrutinib Treatment Improves Itch and Sleep in Chronic Spontaneous Urticaria Patients: Phase 2b Study Results 该研究探讨了新型口服布鲁顿酪氨酸激酶抑制剂remibrutinib（LOU064）对慢性特发性荨麻疹（CSU）患者瘙痒严重程度和睡眠干扰的影响。研究结果显示，与安慰剂相比，remibrutinib在2、4和12周时能够显著降低患者的瘙痒严重程度和睡眠干扰，且有更多患者达到了无瘙痒和无睡眠干扰的状态。这表明remibrutinib治疗能够改善CSU患者的症状，对临床具有重要意义。 2期临床研究 AAD 2023 2023-03-17 慢性荨麻疹 - Remibrutinib Improves Chronic Spontaneous Urticaria in Patients Irrespective of Previous Anti-IgE Treatment: Results From a Phase 2b Study 本研究旨在探讨雷米布替尼（LOU064）对慢性特发性荨麻疹（CSU）患者的影响，无论其是否接受过抗IgE治疗。研究结果显示，雷米布替尼（各剂量）均改善了UAS7，并实现了UAS7=0和UAS7≤6，而且不受先前抗IgE治疗的影响。需要进行更大规模的研究来验证这一Phase 2b研究的结果。在本研究中，311名CSU患者被随机分为雷米布替尼各剂量组和安慰剂组，持续12周。结果显示，无论是否接受过抗IgE治疗，各剂量组在UAS7变化和达到UAS7=0和UAS7≤6的患者比例方面均无明显差异。 2期临床研究 AAAAI 2023 2023-02-01 慢性荨麻疹 Allergy & Asthma Medical Group and Research Center | Novartis Ireland Ltd. | Novartis Pharma AG Remibrutinib (LOU064) in Sjögren’s Syndrome: Safety and Efficacy Results from a 24Week Placebo-controlled Proof-of-Concept Study 本研究报告了一项为期24周的安慰剂对照概念验证试验的安全性和有效性结果，研究对象为原发性干燥综合征（SS）患者。研究结果显示，Remibrutinib在患者中具有良好的安全性和耐受性。与安慰剂相比，Remibrutinib显著改善了ESSDAI评分，并在唾液流量和免疫球蛋白水平上表现出积极的影响。这些结果表明，Remibrutinib可能成为SS的首个有效口服改变疾病进程的治疗药物。然而，需要更长时间的研究来证实潜在的益处，因此需要进行更多的研究来确认Remibrutinib在SS治疗中的益处。 2期临床研究 ACR 2022 2022-11-13 Sjögren’s syndrome (SS) Novartis Institutes for BioMedical Research GmbH & Co. KG | Novartis Pharma AG | Charit Universittsmedizin Berlin REMIBRUTINIB IMPROVES CHRONIC SPONTANEOUS URTICARIA IN PATIENTS IRRESPECTIVE OF CU-INDEX: RESULTS FROM PHASE 2B STUDY 该研究探讨了新型口服布鲁顿酪氨酸激酶抑制剂雷米布替尼（LOU064）对慢性特发性荨麻疹（CSU）患者的影响，不考虑基线CU指数。在这项2b期研究中，311名CSU患者被随机分配到雷米布替尼10mg q.d. / 35mg q.d. / 100mg q.d. / 10mg b.i.d. / 25mg b.i.d. / 100mg b.i.d.或安慰剂治疗12周。结果显示，雷米布替尼（所有剂量）改善了UAS7，不考虑基线CU指数，CU指数阳性患者的改善更明显。雷米布替尼组的患者达到UAS7=0和UAS7≤6的比例均高于安慰剂组，不考虑基线CU指数。需要进行更大规模的研究来确认2b期研究的结果。 2期临床研究 ACAAI 2022 2022-11-10 慢性荨麻疹 Basel,Switzerland | Barcelona,Spain | MissionViejo,CA REMIBRUTINIB IMPROVES CHRONIC SPONTANEOUS URTICARIA IN PATIENTS WITH LOW OR HIGH IGE 该研究调查了慢性特发性荨麻疹（CSU）患者基线IgE水平与雷米布替尼治疗效果的相关性。结果显示，雷米布替尼改善了所有患者的UAS7，不论其基线IgE水平如何。在所有雷米布替尼剂量中，基线IgE≤43IU/mL患者的UAS7改善更大，且更多患者达到了UAS7=0。总体而言，雷米布替尼25mg b.i.d.对UAS7=0和UAS7≤6的改善效果最显著。这一次分析显示了雷米布替尼在基线IgE≤43IU/mL的患者中改善CSU活动控制的潜力。 2期临床研究 ACAAI 2022 2022-11-10 - Berlin,Germany | Rochester,NY | Hiroshima,Japan | Tokyo,Japan | Basel,Switzerland Remibrutinib, a novel Bruton tyrosine kinase inhibitor, exhibits improved target selectivity and potency  in vitro 本研究评估了多种BTK抑制剂在体外的选择性和效力。结果显示，remibrutinib在人体血液中表现出最高的选择性和抑制效力，对B细胞和嗜碱性粒细胞的抑制作用明显。与其他BTK抑制剂相比，remibrutinib的结合能力和选择性更强。这些发现可能对临床疗效和安全性产生影响。该研究有助于指导BTK抑制剂的临床应用，特别是在多发性硬化症的治疗中。 药物发现/临床前 ECTRIMS 2022 2022-10-12 多发性硬化症 Novartis Institutes for Biomedical Research, Inc. Remibrutinib inhibits neuroinflammation driven by B cells and myeloid cells in preclinical models of multiple sclerosis Remibrutinib是一种针对多发性硬化症（MS）的新型治疗选择。它通过抑制B细胞和髓样细胞驱动的神经炎症，在小鼠模型中显示出剂量依赖的疗效。Remibrutinib还通过作用于髓样细胞和微胶质细胞，对临床评分和抗炎效果具有疗效。这些发现支持了Remibrutinib可能成为MS患者的新型治疗选择。Remibrutinib是一种高选择性的BTK抑制剂，对MS具有潜在的临床前和临床疗效。研究结果表明，Remibrutinib通过抑制B细胞依赖的EAE和髓样细胞的抑制，对MS具有疗效。 药物发现/临床前 ECTRIMS 2022 2022-10-12 多发性硬化症 Novartis Institutes for Biomedical Research, Inc. | 康乃德生物医药（上海）有限公司 Remibrutinib (LOU064) treatment improves quality of life in patients with chronic spontaneous urticaria 该研究评估了雷米布替尼（LOU064）对慢性特发性荨麻疹（CSU）患者生活质量的影响。结果显示，雷米布替尼治疗在12周内显著改善了CSU患者的生活质量，各剂量均优于安慰剂。雷米布替尼是一种布鲁顿酪氨酸激酶（BTK）抑制剂，能够阻断肥大细胞和嗜碱性粒细胞的活化，与CSU发病机制相关。研究结果表明，雷米布替尼对CSU患者的生活质量有积极影响，为CSU的新疗法提供了希望。 2期临床研究 EADV 2022 2022-09-07 慢性荨麻疹 - Remibrutinib (LOU064) versus placebo in CSU patients: Study design of two Phase 3 clinical trials REMIX-1 and REMIX-2 本文介绍了两项临床试验REMIX-1和REMIX-2，旨在评估新型口服共价Bruton酪氨酸激酶（BTK）抑制剂Remibrutinib（LOU064）在慢性特发性荨麻疹（CSU）患者中的疗效和安全性。试验采用双盲、随机、安慰剂对照的设计，招募约450名CSU患者，评估Remibrutinib与安慰剂在改善UAS7、ISS7和HSS7等指标上的效果。预计于2024年完成试验，结果将为Remibrutinib在CSU治疗中的临床应用提供更多证据。 3期临床研究 EADV 2022 2022-09-07 慢性荨麻疹 - Long-term safety and tolerability of remibrutinib (LOU064) in Phase 2b study in chronic spontaneous urticaria patients 本研究报告了在慢性特发性荨麻疹（CSU）患者中，长达52周的remibrutinib（LOU064）安全性和耐受性。结果显示，在整个剂量范围内，remibrutinib表现出良好的安全性，长期暴露至100 mg两次每日剂量长达52周，未观察到新的安全信号。研究中未发现严重不良事件，且无临床意义的生化指标和生命体征变化。因此，remibrutinib在CSU患者中显示出良好的安全性和耐受性，为其在慢性特发性荨麻疹治疗中的进一步发展提供了有力支持。 2期临床研究 EADV 2022 2022-09-07 慢性荨麻疹 - No increased rate of infections and infestations with remibrutinib (LOU064) in Phase 2 studies in patients with chronic spontaneous urticaria - 2期临床研究 EADV 2022 2022-09-07 慢性荨麻疹 - Remibrutinib demonstrates faster time to complete urticaria control in patients with chronic spontaneous urticaria compared with placebo 该研究报告了使用雷米布替尼治疗慢性特发性荨麻疹（CSU）患者的临床试验结果。与安慰剂相比，雷米布替尼能更快地实现完全控制和疾病良好控制，且安全性良好。研究结果显示，雷米布替尼在不同剂量下均表现出良好的疗效和安全性。这项研究为CSU患者的治疗提供了新的选择。 2期临床研究 EADV 2022 2022-09-07 慢性荨麻疹 Novartis Pharmaceuticals Corp. Remibrutinib (LOU064) reduces the use of rescue medication in patients with chronic spontaneous urticaria: Findings from a phase 2b study 在慢性特发性荨麻疹患者中，雷米布替尼（LOU064）减少了救援药物的使用：来自2b期研究结果。研究发现雷米布替尼在12周内降低了患者对救援药物的需求，与基线和安慰剂相比，不同剂量下的效果都得到了改善。尽管H1-抗组胺药物的使用减少，但患者的荨麻疹症状有所改善。这项研究对雷米布替尼的用药剂量进行了探索，结果表明在患者中，雷米布替尼能够减少救援药物的使用。 2期临床研究 EADV 2022 2022-09-07 慢性荨麻疹 - REMODEL I/II Trials: Efficacy, Safety, andTolerability of Remibrutinib in PatientsWith Relapsing Multiple Sclerosis 本文总结了REMODEL I/II试验，旨在评估Remibrutinib对复发性多发性硬化症（RMS）患者的疗效、安全性和耐受性。Remibrutinib是一种高选择性的BTK抑制剂，具有短暂的血浆半衰期和良好的药理和安全特性。试验采用随机、双盲、活性对照、并行组设计，招募了年龄在18-55岁之间的患者。主要终点是年复发率，次要/探索性终点包括MRI数据和临床评估。试验目前正在招募参与者，将通过研究结果支持Remibrutinib作为潜在的新口服治疗药物获得全球监管批准。 药物发现/临床前 EAN 2022 2022-06-24 复发性多发性硬化 Novartis Healthcare Pvt Ltd. | University of Münster | Novartis Pharmaceuticals Canada, Inc. | Novartis Pharma AG | Cleveland Clinic Phase 3 REMODEL I/II Trials: Effectiveness, Safety, and Tolerability of Remibrutinib in Patients with Relapsing Multiple Sclerosis (P7-4.003) 本研究旨在评估雷米布替尼和替非鸟胺在复发性多发性硬化患者中的疗效、安全性和耐受性。研究采用相同的随机化、双盲、活性对照、并行分组的设计，招募800名患者。首要终点为年复发率，关键次要终点包括基于EDSS的残疾进展、新/正在扩大的T2和Gd+ T1病变数量、神经丝轻链浓度减少和无病活动证据。此外，还计划在部分患者的6个月核磁共振数据上进行中期分析。研究结果将在会议上详细介绍。 3期临床研究 AAN 2022 2022-05-03 复发性多发性硬化 Novartis Pharma AG | Novartis Pharmaceutical Corporation, East Hanover, New Jersey, United States | Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany | Novartis Healthcare Private Limited, Hyderabad, India Remibrutinib Treatment Improves Quality of Life in Patients with Chronic Spontaneous Urticaria 该研究是一项关于使用雷米布替尼治疗慢性特发性荨麻疹（CSU）患者的生活质量改善的研究。研究结果显示，雷米布替尼在12周内显著改善了CSU患者的生活质量，各剂量均比安慰剂效果显著。研究方法为随机、双盲、安慰剂对照试验，共有309名患者参与。雷米布替尼是一种Bruton酪氨酸激酶（BTK）抑制剂，能够阻断肥大细胞和嗜碱性粒细胞的激活，与CSU的发病机制有关。研究结果表明，雷米布替尼对CSU患者的生活质量改善具有积极作用，对于当前治疗效果不佳的CSU患者具有重要的临床意义。 2期临床研究 AAAAI 2022 2022-02-01 慢性荨麻疹 Novartis Ireland Ltd. | Novartis Pharma AG A Fast and Clean BTK Inhibitor - 药物发现/临床前 J Med Chem 2020-05-13 干燥综合征 | 慢性荨麻疹 Department of Organic Chemistry, Weizmann Institute of Science, Rehovot 7600001, Israel Discovery of LOU064 (Remibrutinib), a Potent and Highly Selective Covalent Inhibitor of Bruton’s Tyrosine Kinase LOU064 (Remibrutinib)是一种对布鲁顿酪氨酸激酶（BTK）具有高选择性和强效的共价抑制剂。它通过结合BTK的非活性构象表现出卓越的激酶选择性，具有潜力成为治疗自身免疫疾病的最佳共价BTK抑制剂。在大鼠胶原诱导性关节炎模型中表现出剂量依赖的疗效，目前正在进行Ⅱ期临床研究，用于慢性特发性荨麻疹和干燥综合征的治疗。 药物发现/临床前 J Med Chem 2020-02-21 自身免疫性疾病 Novartis AG LOU064: A Highly Selective and Potent Covalent Oral BTK Inhibitor with Promising Pharmacodynamic Efficacy on B Cells for Sjoegren’s Syndrome LOU064是一种高选择性和高效的共价口服BTK抑制剂，对Sjoegren综合征的B细胞具有很好的药效。BTK在B细胞、巨噬细胞、肥大细胞和嗜碱性粒细胞中表达，对B细胞抗原受体和Fc受体信号传导起着重要作用。LOU064在体外和体内模型中显示出强大的BTK抑制作用，对健康志愿者和无症状特应性皮肤炎患者的研究结果表明，其口服给药具有快速吸收、快速作用和良好的耐受性。这些数据使LOU064成为治疗B细胞自身免疫和免疫复合物介导的巨噬细胞炎症等慢性疾病的强有力候选药物。 药物发现/临床前 ACR 2019 2019-11-12 Crouzon综合征伴黑棘皮症 Novartis Institutes for Biomedical Research, Inc. | Novartis Institutes of Biomedical Research