Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops , an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor (AhR): The LION Study

The LION Study is a prospective, single-center phase 1 clinical trial to evaluate the safety, tolerability, and distribution of Laquinimod administered as topical eye drops for two weeks in human participants.

开始日期2024-05-03

申办/合作机构

Stanford University

NCT05187403

/ Completed临床1期

A Placebo-Controlled, Double-masked Phase-1 Study in Healthy Subjects Investigating the Safety and Tolerability of Laquinimod Eye Drops

This is a Phase 1 randomized, double-masked, placebo-controlled study performed with healthy participants to assess the safety and tolerability of laquinimod eye-drops.

开始日期2021-12-09

申办/合作机构

Active Biotech AB

NL-OMON43112

/ CompletedN/A

A randomized, open-label, two-way crossover study to assess the relative bioavailability of Laquinimod 0.6 mg test tablet versus Laquinimod 0.6 mg reference capsule after single dose administration with a single sequence extension to assess the pharmacokinetics of Laquinimod and its metabolites after single and multiple oral 0.6 mg dose administration in healthy subjects. - Bioavailability study Laquinimod test tablets

开始日期2016-10-05

申办/合作机构

Teva Pharmaceutical Industries Ltd.

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100 项与拉喹莫德相关的专利（医药）

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项与拉喹莫德相关的文献（医药）

2026-06-01·Ophthalmology science

Safety and Biodistribution of Topical Laquinimod, an Immunomodulator Targeting Aryl Hydrocarbon Receptor: The LION Study

Article

作者: DeBoer, Charles ; Mobasserian, Azadeh ; Elaraby, Osama ; Serag, Yasser ; Khan, Hareem ; Vahtola, Erik ; Akhavanrezayat, Amir ; Kabeel, Mamdouh ; Tuong Than, Ngoc Trong ; Do, Diana V ; Urtti, Arto ; Khatri, Anadi ; Or, Christopher ; Moussa, Magdy ; Halim, Muhammad Sohail ; El Feky, Dalia ; Yavari, Negin ; Törngren, Marie ; Mruthyunjaya, Prithvi ; Tram Tran, Anh Ngoc ; Hung, Jia-Horung ; Smith, Stephen ; Kirimli, Gunay Uludag ; Nguyen, Quan Dong

Purpose:

To evaluate the safety, tolerability, and distribution of laquinimod (LAQ) eye drops as a potential steroid-sparing anti-inflammatory therapy.

Design:

Phase I clinical trial conducted at the Byers Eye Institute, Stanford University. NCT06161415.

Participants:

Patients scheduled for elective pars plana vitrectomy for various noninfectious indications.

Methods:

Enrolled subjects were instructed on proper LAQ storage and administration and received the drops for 14 days prior to surgery. Patients were sequentially assigned into 3 groups receiving daily LAQ doses of 0.6, 1.2, and 1.8 mg, with dose escalation permitted only in the absence of safety concerns in the preceding cohort. A preoperative visit was performed following 7 days of LAQ administration. On the day of surgery, aqueous, vitreous, and plasma samples were collected for LAQ quantification. Two postoperative follow-up visits were conducted.

Main Outcome Measures:

Tolerability; safety of the LAQ eye drop, assessed via ophthalmic examination, multimodal imaging, laboratory tests, and electrocardiogram; and LAQ concentrations in aqueous, vitreous, and plasma.

Results:

Ten participants completed the 14-day topical LAQ and all study visits, except one where pars plana vitrectomy was canceled; however, subject completed LAQ course and safety follow-up. The mean age was 59.9 ± 15 years, with a female predominance (70%). Given there were no dose-limiting toxicities, participants sequentially received daily doses of 0.6 mg (n = 4), 1.2 mg (n = 3), and 1.8 mg (n = 3). Following the exclusion of insufficient samples, LAQ levels were analyzed in 8 vitreous and 7 aqueous specimens. Laquinimod was well tolerated at all doses, with 3 adverse events unrelated to the study drug. Laquinimod was detected in aqueous, vitreous, and plasma with dose-dependent levels across all doses. Mean total LAQ level was significantly higher in aqueous rising from 508.5 to 3640.0 ng/mL, exceeding vitreous levels that rose from 6.89 to 38.50 ng/mL. Notably, unbound LAQ levels remained significant. Plasma concentrations remain within established safety ranges, with mean LAQ levels increasing from 153.4 to 563.5 ng/mL.

Conclusions:

Topical LAQ was safe and well tolerated at daily doses of 0.6, 1.2, and 1.8 mg, with measurable penetration into the posterior segment. Dose-dependent drug levels were detected in vitreous, aqueous, and plasma. These findings support investigation of LAQ's therapeutic potential for inflammatory eye diseases.

Financial Disclosures:

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

2025-06-01·NEUROREHABILITATION

What Is the Evidence on Immunomodulators and Immunosuppressants for Progressive Multiple Sclerosis? - A Cochrane Review Summary with Commentary.

Review

作者: Moretti, Antimo

BackgroundMultiple sclerosis (MS) is a chronic inflammatory demyelinating disease affecting the central nervous system and is a major cause of disability in adults, particularly in those affected by progressive MS. A variety of drugs with different effects, some carrying significant risks, are currently available, making evidence-based approach essential for clinicians treating MS patients.ObjectiveTo compare the efficacy and safety of immunomodulators and immunosuppressants for progressive multiple sclerosis (PMS).MethodsA systematic search was performed in CENTRAL, MEDLINE, Embase, and trials registers on 8 august 2022, including RCTs comparing immunomodulators and immunosuppressants versus placebo or another drug.ResultsThe network meta-analysis (NMA) included 23 RCTs (with 10,167 participants). Moderate certainty of evidence suggests that rituximab probably not reduce the risk of relapse at 2 years, while interferon beta-1b probably reduces the risk of relapses at 3 years (-18%) compared to placebo in PMS people. Regarding SAE, low-to-very-low certainty of evidence for no increased risk with disease-modifying therapies (DMTs) versus placebo is available, except for immunoglobulins that seem to have a 7-fold increased risk of serious adverse events (SAEs). Only low-to-very low certainty of evidence is available about disability progression and SAEs in PMS people treated with DMTs versus placebo. On the other side, the risk for treatment discontinuation due to AEs is increased with interferon beta-1a by 2.93-fold, and probably increased with interferon-beta-1b, glatiramer acetate, and fingolimod by 2.98-fold, 3.98-fold, and 2.29-fold, respectively. Also, rituximab, natalizumab, siponimod, and ocrelizumab probably do not increase the risk for treatment discontinuation due to AEs, while laquinimod may not increase the risk treatment discontinuation due to AEs.ConclusionsCompared with placebo, two-, and three-year treatment with rituximab or interferon beta-1b, respectively, probably slightly reduce relapses in PMS people. A slight increase of treatment discontinuation due to AEs has been reported for rituximab, interferon beta-1b, interferon beta-1a, immunoglobulins, glatiramer acetate, natalizumab, fingolimod, siponimod, and ocrelizumab. No reliable evidence is available for disability progression and SAEs with available DMTs compared to placebo.

2025-02-01·JOURNAL OF INTERNATIONAL MEDICAL RESEARCH

Efficacy and safety of laquinimod versus placebo in relapsing-remitting multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials

Review

作者: Amna Hussain ; Muhammad Haris Khan ; Touba Azeem ; Moosa Ali ; Arysha Monis ; Ammara Tahir ; Abdul Moeez ; Fazia Khattak ; Malik Waleed Zeb Khan ; Safeena Khan ; Aban Masaud Mian ; Aizaz Ali ; Jibran Ikram

Objective:

To investigate the safety and efficacy of laquinimod in treating relapsing-remitting multiple sclerosis (RRMS).

Methods:

An extensive electronic search was conducted across PubMed, Embase, Cochrane Database of Systematic Reviews, and ClinicalTrials.gov to identify suitable studies. Risk of bias was assessed using Cochrane’s Risk of Bias tool. Statistical analysis was performed using RevMan 5.4.1.

Results:

The meta-analysis of four randomized controlled trials including 3665 patients found that laquinimod significantly reduced the annualized relapse rate compared with placebo (mean difference = −0.08, 95% confidence interval [CI] = −0.12, −0.04, I2 = 0%). For disability progression confirmed at 3 months, laquinimod provided a significant advantage over placebo (hazard ratio [HR] = 0.75, 95% CI = 0.59, 0.96, I2 = 25%), whereas no benefit was achieved at 6 months (HR = 0.69, 95% CI = 0.45, 1.06, I2 = 66%). Laquinimod was also significantly better than placebo in maintaining a relapse-free status (risk ratio [RR] = 1.14 95% CI = 1.06, 1.22, I2 = 10%). Laquinimod had a comparable safety profile as placebo (RR = 1.06, 95% CI = 0.81, 1.39, I2 = 33%).

Conclusions:

These findings support the efficacy of laquinimod in managing RRMS but necessitate careful monitoring during treatment.

项与拉喹莫德相关的新闻（医药）

2026-09-20

·Pharm-Patent

拉喹莫德研究进展（V1,2026.9.20更新）

Laquinimod targets the aryl hydrocarbon receptor (AhR) that is present in antigen-presenting cells and involved in the regulation of these cells. By targeting the AhR, antigen presenting cells are re-programmed to become tolerogenic, so that instead of activating pro-inflammatory T cells, regulatory T cells with anti-inflammatory properties are activated leading to dampening of the inflammation in the eye. 1、研究机构：梯瓦制药、Active Biotech 2、别名：ABR-215062、laquinimod sodium、Nerventr 3、靶点：AHR 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；滴眼剂; 眼部给药 5、结构式 6、适应症及进展适应症进展最新进展日期亨廷顿舞蹈病 II期 2024-01-24 葡萄膜炎 I期 2025-10-20 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 Synthesis and biological evaluation of new 1,2-dihydro-4-hydroxy-2-oxo-3-quinolinecarboxamides for treatment of autoimmune disorders: structure-activity relationship 药物发现多发性硬化 Active Biotech J Med Chem IF=7.3 2004-04-08 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 CN103119023B 制备工艺生产喹啉-3-羧酰胺的改进方法 2011-07-07 CN114845718B 用途用于治疗与过度血管形成相关的眼部疾病的化合物 2020-12-18 US12208091B2 用途用于治疗与过度血管化相关的眼部疾病的化合物 2022-09-07 9、研究历程 2021年12月10日，由Active Biotech Ab在瑞典开展临床一期试验，用于治疗葡萄膜炎。（https://www.activebiotech.com/en/media/pressreleases/?id=2349825） 2021年12月09日，由Active Biotech Ab在奥地利开展临床一期试验，用于治疗眼部疾病。（NCT05187403） 2018年08月07日，治疗亨廷顿舞蹈症的研究暂无进展。（NCT02215616） 2018年02月08日，治疗慢性进行性多发性硬化的研究暂无进展。（NCT02284568） 2017年10月09日，治疗复发-缓解型多发性硬化的研究终止。（NCT00745615） 2017年09月13日，治疗多发性硬化的研究终止。（NCT00988052; NCT01707992; NCT00605215; NCT01047319; NCT00509145） 2017年05月15日，治疗多发性硬化的研究暂无进展。（NCT01707992; NCT00509145） 2015年01月26日，临床一期研究暂无进展。（NCT02085863） 2015年01月12日，由Teva Branded Pharmaceutical Products R&D Inc在加拿大、德国和意大利等国家和地区开展临床二期试验，用于治疗慢性进行性多发性硬化。（NCT02284568） 2014年10月28日，由Teva Branded Pharmaceutical Products R&D Inc在加拿大、德国和意大利等国家和地区开展临床二期试验，用于治疗亨廷顿舞蹈症。（NCT02215616） 2014年08月19日，治疗多发性硬化的研究终止。（EMEA/H/C/002546） 2014年03月03日，治疗复发-缓解型多发性硬化的研究终止。（NCT01975298） 2014年02月01日，由Teva Branded Pharmaceutical Products R&D Inc在德国开展临床一期试验。（NCT02085863） 2014年01月01日，由Teva Branded Pharmaceutical Products R&D Inc开展临床三期试验，用于治疗复发-缓解型多发性硬化。（NCT01975298） 2013年08月26日，治疗多发性硬化的研究终止。（NCT01404117） 2013年02月20日，由Teva Branded Pharmaceutical Products R&D Inc在白俄罗斯、比利时和波斯尼亚和黑塞哥维那等国家和地区开展临床三期试验，用于治疗多发性硬化。（NCT01707992） 2013年01月09日，治疗关节炎和狼疮肾炎的研究暂无进展。（NCT01085084; NCT01085097） 2012年08月01日，由Teva Pharmaceuticals International Gmbh向欧洲药品管理局EMA和加拿大提交上市申请，用于治疗多发性硬化。 2012年03月01日，由Teva Branded Pharmaceutical Products R&D Inc开展临床二期试验，用于治疗多发性硬化。（NCT01404117） 2012年01月24日，治疗克罗恩病和多发性硬化的研究暂无进展。（NCT00605215; NCT00737932） 2010年10月04日，由Teva Branded Pharmaceutical Products R&D Inc在加拿大和美国开展临床二期试验，用于治疗关节炎。（NCT01085084） 2010年09月01日，由Teva Branded Pharmaceutical Products R&D Inc在加拿大、法国和俄罗斯联邦等国家和地区开展临床二期试验，用于治疗狼疮肾炎。（NCT01085097） 2010年05月01日，由Teva Branded Pharmaceutical Products R&D Inc在比利时、法国和意大利等国家和地区开展临床二期试验，用于治疗克罗恩病。（NCT00737932） 2008年04月24日，由Teva Branded Pharmaceutical Products R&D Inc在波多黎各、斯洛伐克和南非等国家和地区开展临床三期试验，用于治疗多发性硬化。（NCT01707992; NCT00605215; NCT01047319） 2007年11月13日，由Teva Branded Pharmaceutical Products R&D Inc在奥地利、保加利亚和加拿大等国家和地区开展临床三期试验，用于治疗多发性硬化。（NCT00988052; NCT01707992; NCT00605215; NCT01047319; NCT00509145） 2005年12月07日，由以色列梯瓦制药工业有限公司在德国、匈牙利和意大利等国家和地区开展临床二期试验，用于治疗复发-缓解型多发性硬化。（NCT00745615） 2005年03月01日，由Teva Branded Pharmaceutical Products R&D Inc开展临床二期试验，用于治疗复发-缓解型多发性硬化。（NCT00349193） 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 NCT06161415 Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops , an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor (AhR): The LION Study 拉喹莫德 (滴眼剂, 局部给药) 葡萄膜炎 | 炎症 Inflammation | Uveitis Stanford University Recruiting 临床1期 2024-05-03 2025-07-01 美国 NCT05187403 A Placebo-Controlled, Double-masked Phase-1 Study in Healthy Subjects Investigating the Safety and Tolerability of Laquinimod Eye Drops 拉喹莫德 (滴眼剂, Eye-drops) 眼部疾病 Eye Diseases Active Biotech AB Completed 临床1期 2021-12-09 2023-01-19 奥地利 NL-OMON43112 A randomized, open-label, two-way crossover study to assess the relative bioavailability of Laquinimod 0.6 mg test tablet versus Laquinimod 0.6 mg reference capsule after single dose administration with a single sequence extension to assess the pharmacokinetics of Laquinimod and its metabolites after single and multiple oral 0.6 mg dose administration in healthy subjects. - Bioavailability study Laquinimod test tablets 拉喹莫德 - Huntington's Disease and Multiple Sclerose | 10007951 Teva Pharmaceutical Industries Ltd. Completed N/A 2016-10-05 - 荷兰 NCT02284568 A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS) 拉喹莫德原发性进行性多发性硬化 Primary Progressive Multiple Sclerosis Teva Branded Pharmaceutical Products R&D LLC Completed 临床2期 2015-01-12 2017-10-01 加拿大 | 俄罗斯 | 荷兰 | 美国 | 乌克兰 | 波兰 | 英国 | 意大利 | 德国 | 西班牙 NCT02215616 A Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/Day) as Treatment in Patients With Huntington's Disease 拉喹莫德亨廷顿舞蹈病 Huntington's Disease Teva Branded Pharmaceutical Products R&D LLC Completed 临床2期 2014-10-28 2018-06-19 加拿大 | 俄罗斯 | 荷兰 | 捷克 | 美国 | 英国 | 意大利 | 葡萄牙 | 德国 | 西班牙 NCT02085863 A Randomized, Double-Blind, Placebo-Controlled, Two-way Crossover Drug-drug Interaction Study to Assess the Effect of Laquinimod 0.6 mg on the Pharmacokinetics and Pharmacodynamics of Ethinylestradiol and Levonorgestrel in Healthy Young Women 拉喹莫德 - Pharmacokinetics | Pharmacodynamics Teva Branded Pharmaceutical Products R&D LLC Completed 临床1期 2014-02-01 2014-11-01 德国 NCT01975298 A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate The Efficacy, Safety And Tolerability Of 2 Doses Of Oral Administration Of Laquinimod (0.6 mg/Day Or 1.2 mg/Day) Compared to Interferon ß-1a Administered Intra Muscular Once Weekly in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). 拉喹莫德复发-缓解型多发性硬化 Relapsing Remitting Multiple Sclerosis Teva Branded Pharmaceutical Products R&D LLC Withdrawn 临床3期 2014-01-01 2014-03-01 - NCT01707992 A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) 拉喹莫德复发-缓解型多发性硬化 Multiple Sclerosis Teva Branded Pharmaceutical Products R&D LLC Completed 临床3期 2013-02-20 2017-07-04 俄罗斯 | 捷克 | 美国 | 希腊 | 拉脱维亚 | 奥地利 | 波兰 | 韩国 | 斯洛伐克 | 塞尔维亚共和国 | 法国 | 保加利亚 | 波黑 | 克罗地亚 | 罗马尼亚 | 匈牙利 | 乌克兰 | 英国 | 白俄罗斯 | 西班牙 | 加拿大 | 比利时 | 摩尔多瓦 | 北马其顿共和国 | 意大利 | 以色列 | 黑山共和国 | 德国 | 爱沙尼亚 NCT01404117 A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability 拉喹莫德复发性多发性硬化 Relapsing Multiple Sclerosis Teva Branded Pharmaceutical Products R&D LLC Withdrawn 临床2期 2012-03-01 2014-01-01 - NCT01085084 A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus Arthritis 拉喹莫德系统性红斑狼疮 Lupus Arthritis Teva Branded Pharmaceutical Products R&D LLC Completed 临床2期 2010-10-04 2012-11-12 加拿大 | 美国 NCT01085097 A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids) 甲泼尼龙 | 泼尼松 | 醋酸泼尼松龙 | 吗替麦考酚酯 | 拉喹莫德狼疮性肾炎 Lupus Nephritis Teva Branded Pharmaceutical Products R&D LLC Completed 临床2期 2010-09-01 2012-10-24 加拿大 | 俄罗斯 | 美国 | 英国 | 法国 NCT01047319 A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple Sclerosis 拉喹莫德复发性多发性硬化 Relapsing Multiple Sclerosis Teva Branded Pharmaceutical Products R&D LLC Terminated 临床3期 2010-05-27 2017-06-30 俄罗斯 | 罗马尼亚 | 捷克 | 美国 | 乌克兰 | 西班牙 | 波兰 | 北马其顿共和国 | 南非 | 意大利 | 斯洛伐克 | 以色列 | 立陶宛 | 保加利亚 | 德国 | 爱沙尼亚 | 克罗地亚 NCT00988052 A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS 拉喹莫德复发性多发性硬化 Relapsing Multiple Sclerosis Teva Branded Pharmaceutical Products R&D LLC Terminated 临床3期 2009-11-10 2017-07-01 俄罗斯 | 罗马尼亚 | 匈牙利 | 捷克 | 美国 | 乌克兰 | 英国 | 西班牙 | 加拿大 | 瑞典 | 荷兰 | 奥地利 | 土耳其 | 波兰 | 意大利 | 以色列 | 塞尔维亚共和国 | 立陶宛 | 法国 | 保加利亚 | 德国 | 爱沙尼亚 NCT00737932 A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease. 拉喹莫德克罗恩病 Crohn's Disease Teva Branded Pharmaceutical Products R&D LLC Completed 临床2期 2010-05-01 2011-12-01 荷兰 | 比利时 | 波兰 | 英国 | 南非 | 意大利 | 以色列 | 法国 | 西班牙 NCT00605215 A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon β-1a (Avonex®) in a Rater-blinded Design 拉喹莫德复发-缓解型多发性硬化 Multiple Sclerosis Teva Branded Pharmaceutical Products R&D LLC Completed 临床3期 2008-04-24 2011-06-10 俄罗斯 | 美国 | 罗马尼亚 | 捷克 | 乌克兰 | 西班牙 | 波兰 | 北马其顿共和国 | 南非 | 意大利 | 斯洛伐克 | 以色列 | 立陶宛 | 保加利亚 | 德国 | 爱沙尼亚 | 克罗地亚 NCT00509145 A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With RRMS 拉喹莫德复发-缓解型多发性硬化 Multiple Sclerosis Teva Branded Pharmaceutical Products R&D LLC Completed 临床3期 2007-11-13 2010-11-08 俄罗斯 | 罗马尼亚 | 匈牙利 | 捷克 | 美国 | 乌克兰 | 英国 | 西班牙 | 加拿大 | 瑞典 | 荷兰 | 拉脱维亚 | 奥地利 | 土耳其 | 波兰 | 意大利 | 以色列 | 塞尔维亚共和国 | 立陶宛 | 法国 | 保加利亚 | 德国 | 爱沙尼亚 NCT00349193 A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects 拉喹莫德复发-缓解型多发性硬化 Relapsing Remitting Multiple Sclerosis Teva Branded Pharmaceutical Products R&D LLC Completed 临床2期 2005-03-01 2006-08-01 - 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/合作机构主要研究药物来源链接 Synapse链接 Safety and Biodistribution of Topical Laquinimod, an Immunomodulator Targeting Aryl Hydrocarbon Receptor: The LION Study NCT06161415 Pubmed 临床1期眼部疾病 10 Laquinimod 0.6 mg AE = Laquinimod was well tolerated at all doses, with 3 adverse events unrelated to the study drug 积极 2026-06-01 Stanford University 拉喹莫德 https://pubmed.ncbi.nlm.nih.gov/42211725/ | https://doi.org/10.1016/j.xops.2026.101186 https://synapse.zhihuiya.com/clinical-result-detail/3422838e5ad003a0245d5eea0a0ded55 Safety and Biodistribution of Topical Laquinimod, an Immunomodulator Targeting Aryl Hydrocarbon Receptor: The LION Study NCT06161415 Pubmed 临床1期眼部疾病 10 Laquinimod 1.2 mg AE = Laquinimod was well tolerated at all doses, with 3 adverse events unrelated to the study drug 积极 2026-06-01 Stanford University 拉喹莫德 https://pubmed.ncbi.nlm.nih.gov/42211725/ | https://doi.org/10.1016/j.xops.2026.101186 https://synapse.zhihuiya.com/clinical-result-detail/3422838e5ad003a0245d5eea0a0ded55 A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus Arthritis NCT01085084 CTgov 临床2期系统性红斑狼疮 82 Placebo(Placebo) Number of Participants With Adverse Events (AEs) = 21 Pts - 2022-07-07 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT01085084 https://synapse.zhihuiya.com/clinical-result-detail/4e5522ea05e4a25553ae5a92e92042ee A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus Arthritis NCT01085084 CTgov 临床2期系统性红斑狼疮 82 Placebo+Laquinimod(Laquinimod 0.5 mg) Number of Participants With Adverse Events (AEs) = 29 Pts - 2022-07-07 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT01085084 https://synapse.zhihuiya.com/clinical-result-detail/4e5522ea05e4a25553ae5a92e92042ee A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon β-1a (Avonex®) in a Rater-blinded Design NCT00605215 CTgov 临床3期复发-缓解型多发性硬化 1331 Placebo(Placebo) Annualized Rate of Confirmed Relapses(Mean) = 0.344 relapse per year (95%CI, 0.291 ~ 0.406) - 2022-04-21 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT00605215 https://synapse.zhihuiya.com/clinical-result-detail/08e458e9535d8ead32a28e599428334a A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon β-1a (Avonex®) in a Rater-blinded Design NCT00605215 CTgov 临床3期复发-缓解型多发性硬化 1331 Laquinimod(Laquinimod) Annualized Rate of Confirmed Relapses(Mean) = 0.283 relapse per year (95%CI, 0.237 ~ 0.337) - 2022-04-21 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT00605215 https://synapse.zhihuiya.com/clinical-result-detail/08e458e9535d8ead32a28e599428334a A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids) NCT01085097 CTgov 临床2期狼疮性肾炎 46 Placebo+Methylprednisolone+Prednisone+Prednisolone+mycophenolate mofetil(Placebo) Number of Participants With Adverse Events (AEs) = 14 Pts - 2022-03-09 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT01085097 https://synapse.zhihuiya.com/clinical-result-detail/902a3352254558538a8e38ed2492a2a2 A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids) NCT01085097 CTgov 临床2期狼疮性肾炎 46 Placebo+Methylprednisolone+Prednisone+Prednisolone+mycophenolate mofetil+Laquinimod(Laquinimod 0.5 mg) Number of Participants With Adverse Events (AEs) = 15 Pts - 2022-03-09 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT01085097 https://synapse.zhihuiya.com/clinical-result-detail/902a3352254558538a8e38ed2492a2a2 A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With RRMS NCT00509145 CTgov 临床3期复发-缓解型多发性硬化 1106 Laquinimod(Laquinimod) Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period(Mean) = 0.54 Confirmed relapses - 2021-11-02 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT00509145 https://synapse.zhihuiya.com/clinical-result-detail/a5a93de38aa8ad52e0e288052258a252 A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With RRMS NCT00509145 CTgov 临床3期复发-缓解型多发性硬化 1106 Placebo(Placebo) Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period(Mean) = 0.67 Confirmed relapses - 2021-11-02 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT00509145 https://synapse.zhihuiya.com/clinical-result-detail/a5a93de38aa8ad52e0e288052258a252 CONCERTO: A randomized, placebo-controlled trial of oral laquinimod in relapsing-remitting multiple sclerosis. NCT01707992 Pubmed 临床3期复发-缓解型多发性硬化 2199 Laquinimod 0.6 mg PBVC(from baseline to Month 15) = 40 % 不佳 2021-08-11 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://pubmed.ncbi.nlm.nih.gov/34378456/ | https://doi.org/10.1177/13524585211032803 https://synapse.zhihuiya.com/clinical-result-detail/8533d2829a2ada382832a35e2e823489 A randomized, placebo-controlled, phase 2 trial of laquinimod in primary progressive multiple sclerosis NCT02284568 Pubmed 临床2期原发性进行性多发性硬化 374 Laquinimod 0.6 mg Number of new T2 brain lesions: risk ratio = 0.4(95% CI, 0.26 ~ 0.69), P-Value = 0.001 不佳 2020-08-25 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://pubmed.ncbi.nlm.nih.gov/32651286/ | https://doi.org/10.1212/wnl.0000000000010284 https://synapse.zhihuiya.com/clinical-result-detail/22ea282eae2aee24e0de235a92d5e824 A randomized, placebo-controlled, phase 2 trial of laquinimod in primary progressive multiple sclerosis NCT02284568 Pubmed 临床2期原发性进行性多发性硬化 374 Placebo Number of new T2 brain lesions: risk ratio = 0.4(95% CI, 0.26 ~ 0.69), P-Value = 0.001 不佳 2020-08-25 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://pubmed.ncbi.nlm.nih.gov/32651286/ | https://doi.org/10.1212/wnl.0000000000010284 https://synapse.zhihuiya.com/clinical-result-detail/22ea282eae2aee24e0de235a92d5e824 Brain MRI Volume Changes after 12 months laquinimod treatment of Huntington disease (LEGATO-HD) NCT02215616 MDS 临床2期亨廷顿舞蹈病 - Laquinimod 1.0 mg CV change = reduced % 不佳 2019-09-22 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://www.mdsabstracts.org/abstract/brain-mri-volume-changes-after-12-months-laquinimod-treatment-of-huntington-disease-legato-hd https://synapse.zhihuiya.com/clinical-result-detail/a5ad45e8402aeee952a55e8020e029d5 Brain MRI Volume Changes after 12 months laquinimod treatment of Huntington disease (LEGATO-HD) NCT02215616 MDS 临床2期亨廷顿舞蹈病 - Placebo CV change = loss % 不佳 2019-09-22 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://www.mdsabstracts.org/abstract/brain-mri-volume-changes-after-12-months-laquinimod-treatment-of-huntington-disease-legato-hd https://synapse.zhihuiya.com/clinical-result-detail/a5ad45e8402aeee952a55e8020e029d5 A Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/Day) as Treatment in Patients With Huntington's Disease NCT02215616 CTgov 临床2期亨廷顿舞蹈病 352 Placebo(Placebo) Change From Baseline in UHDRS-TMS at Week 52(Mean) = 1.3 Unit - 2019-06-19 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT02215616 https://synapse.zhihuiya.com/clinical-result-detail/e3e52aa245e8535ead89e28a85e5e382 A Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/Day) as Treatment in Patients With Huntington's Disease NCT02215616 CTgov 临床2期亨廷顿舞蹈病 352 Placebo+Laquinimod(Laquinimod 0.5 mg) Change From Baseline in UHDRS-TMS at Week 52(Mean) = 1.4 Unit - 2019-06-19 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT02215616 https://synapse.zhihuiya.com/clinical-result-detail/e3e52aa245e8535ead89e28a85e5e382 The Efficacy and Safety Results of Laquinimod as a Treatment for Huntington Disease (LEGATO-HD) (S16.007) NCT02215616 AAN 临床2期亨廷顿舞蹈病 - laquinimod UHDRS-TMS: P-Value = 0.4853 不佳 2019-04-16 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://www.activebiotech.com/wp-content/uploads/Reilmann-Full-results-AAN-2019-submission-proof-19Oct2018.pdf | https://www.neurology.org/doi/full/10.1212/WNL.92.15_supplement.S16.007 https://synapse.zhihuiya.com/clinical-result-detail/08eeaa33d4e89e0d224e34d0dd5e2828 The Efficacy and Safety Results of Laquinimod as a Treatment for Huntington Disease (LEGATO-HD) (S16.007) NCT02215616 AAN 临床2期亨廷顿舞蹈病 - Placebo UHDRS-TMS: P-Value = 0.4853 不佳 2019-04-16 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://www.activebiotech.com/wp-content/uploads/Reilmann-Full-results-AAN-2019-submission-proof-19Oct2018.pdf | https://www.neurology.org/doi/full/10.1212/WNL.92.15_supplement.S16.007 https://synapse.zhihuiya.com/clinical-result-detail/08eeaa33d4e89e0d224e34d0dd5e2828 An Active Extension of LAQ/5062 Study. A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3 mg and 0.6 mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects (Study LAQ/5063 Active Double-Blind Phase) Followed by an Open Label Phase of Laquinimod 0.6 mg Daily (LAQ/5063 OL) NCT00745615 CTgov 临床2期复发-缓解型多发性硬化 257 Laquinimod(Double-Blind: Laquinimod 0.3 mg) Double-Blind Extension Period: Number of Participants With Adverse Events (AEs) = 57 Pts - 2019-03-27 Teva Pharmaceutical Industries Ltd. 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT00745615 https://synapse.zhihuiya.com/clinical-result-detail/59340222a20d228eeed4ea8daae8e905 An Active Extension of LAQ/5062 Study. A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3 mg and 0.6 mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects (Study LAQ/5063 Active Double-Blind Phase) Followed by an Open Label Phase of Laquinimod 0.6 mg Daily (LAQ/5063 OL) NCT00745615 CTgov 临床2期复发-缓解型多发性硬化 257 Laquinimod(Double-Blind: Laquinimod 0.6 mg) Double-Blind Extension Period: Number of Participants With Adverse Events (AEs) = 66 Pts - 2019-03-27 Teva Pharmaceutical Industries Ltd. 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT00745615 https://synapse.zhihuiya.com/clinical-result-detail/59340222a20d228eeed4ea8daae8e905 A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) NCT01707992 CTgov 临床3期复发-缓解型多发性硬化 2199 Placebo(Placebo-Controlled Phase: Placebo) Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) = 73 Pts - 2019-03-13 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT01707992 https://synapse.zhihuiya.com/clinical-result-detail/5e0a8a24485ea302a3eee82d5a2253de A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) NCT01707992 CTgov 临床3期复发-缓解型多发性硬化 2199 Placebo+Laquinimod(Placebo-Controlled Phase: Laquinimod 0.6 mg) Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) = 66 Pts - 2019-03-13 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT01707992 https://synapse.zhihuiya.com/clinical-result-detail/5e0a8a24485ea302a3eee82d5a2253de A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple Sclerosis NCT01047319 CTgov 临床3期复发性多发性硬化 1047 Laquinimod(Early Laquinimod) =>1 TEAE = 290 Pts - 2019-01-09 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT01047319 https://synapse.zhihuiya.com/clinical-result-detail/e90522382243a5e580eee9282ae52d2a A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple Sclerosis NCT01047319 CTgov 临床3期复发性多发性硬化 1047 placebo+laquinimod(Switch From Placebo) =>1 TEAE = 303 Pts - 2019-01-09 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT01047319 https://synapse.zhihuiya.com/clinical-result-detail/e90522382243a5e580eee9282ae52d2a A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS NCT00988052 CTgov 临床3期复发性多发性硬化 839 Laquinimod(Early Laquinimod) =>1 TEAE = 375 Pts - 2019-01-08 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT00988052 https://synapse.zhihuiya.com/clinical-result-detail/3a85a82295824dae2d2e8a8e8828d559 A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS NCT00988052 CTgov 临床3期复发性多发性硬化 839 placebo+laquinimod(Switch From Placebo) =>1 TEAE = 374 Pts - 2019-01-08 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT00988052 https://synapse.zhihuiya.com/clinical-result-detail/3a85a82295824dae2d2e8a8e8828d559 A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS) NCT02284568 CTgov 临床2期原发性进行性多发性硬化 374 Placebo(Placebo) Percent Brain Volume Change (PBVC) From Baseline to Week 48 Using a Repeated Measures ANCOVA Model(Mean) = -0.454 percentage change from baseline - 2018-11-02 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT02284568 https://synapse.zhihuiya.com/clinical-result-detail/e2542a52e032a95aa8a5442e88e4e8e3 A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS) NCT02284568 CTgov 临床2期原发性进行性多发性硬化 374 Placebo+Laquinimod(Laquinimod 0.6 mg) Percent Brain Volume Change (PBVC) From Baseline to Week 48 Using a Repeated Measures ANCOVA Model(Mean) = -0.438 percentage change from baseline - 2018-11-02 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://clinicaltrials.gov/ct2/show/results/NCT02284568 https://synapse.zhihuiya.com/clinical-result-detail/e2542a52e032a95aa8a5442e88e4e8e3 Long-Term Follow-Up of Laquinimod 0.6 mg in Patients with Relapsing-Remitting Multiple Sclerosis 2 (P3.087) - AAN 临床3期复发-缓解型多发性硬化 2347 Laquinimod 0.6 mg AE = 7 % 积极 2016-04-05 Heinrich-Heine-Universität Düsseldorf 拉喹莫德 https://www.neurology.org/doi/full/10.1212/WNL.86.16_supplement.P3.087 https://synapse.zhihuiya.com/clinical-result-detail/25ae2ede58a5e85a8282833e222a58a2 A phase II study of laquinimod in Crohn's disease NCT00737932 Pubmed 临床2期克罗恩病 180 laquinimod 缓解(0.5mg) = 48.3 % (95%CI, 31 ~ 66) 积极 2015-08-01 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://pubmed.ncbi.nlm.nih.gov/25281416/ | https://doi.org/10.1136/gutjnl-2014-307118 https://synapse.zhihuiya.com/clinical-result-detail/ee5aa922242e9980e25d5308823483aa A phase II study of laquinimod in Crohn's disease NCT00737932 Pubmed 临床2期克罗恩病 180 Placebo 缓解(0.5mg) = 15.9 % (95%CI, 9 ~ 27) 积极 2015-08-01 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://pubmed.ncbi.nlm.nih.gov/25281416/ | https://doi.org/10.1136/gutjnl-2014-307118 https://synapse.zhihuiya.com/clinical-result-detail/ee5aa922242e9980e25d5308823483aa Ambulation benefit with laquinimod in patients with worsening MS (EDSS over 3) is consistent with reduction in confirmed disability progression. - ECTRIMS 临床3期多发性硬化症 1990 Laquinimod 0.6mg QD T25FW = -2.79 Second 积极 2014-09-09 Teva Pharmaceutical Industries Ltd. 拉喹莫德 https://journals.sagepub.com/doi/epub/10.1177/1352458514546077 https://synapse.zhihuiya.com/clinical-result-detail/25de52e82503555ad298290389885ad8 FC1.3 Long-term follow-up of laquinimod in patients with relapsing-remitting multiple sclerosis - ECTRIMS 临床3期复发-缓解型多发性硬化 1009 Laquinimod 0.6mg QD AE rates = Adverse event (AE) and serious AE rates were lower during open-label extension than in the core studies 积极 2014-09-09 Teva Pharmaceutical Industries Ltd. 拉喹莫德 https://journals.sagepub.com/doi/full/10.1177/1352458514546076 https://synapse.zhihuiya.com/clinical-result-detail/da3022208852528805d5922835323452 FC1.3 Long-term follow-up of laquinimod in patients with relapsing-remitting multiple sclerosis - ECTRIMS 临床3期复发-缓解型多发性硬化 1009 Placebo AE rates = Adverse event (AE) and serious AE rates were lower during open-label extension than in the core studies 积极 2014-09-09 Teva Pharmaceutical Industries Ltd. 拉喹莫德 https://journals.sagepub.com/doi/full/10.1177/1352458514546076 https://synapse.zhihuiya.com/clinical-result-detail/da3022208852528805d5922835323452 P386 Pharmacokinetics of laquinimod in patients with active moderate to severe Crohn's disease NCT00737932 ECCO 临床2期活动性重度克罗恩病 180 Laquinimod 0.5 mg AUC = 6996 h · ng/mL (mean(SD), (2063)) 积极 2014-02-01 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://academic.oup.com/ecco-jcc/article/8/Supplement_1/S226/369200 https://synapse.zhihuiya.com/clinical-result-detail/aaa0d358e2583552e5822a8a23a24202 P386 Pharmacokinetics of laquinimod in patients with active moderate to severe Crohn's disease NCT00737932 ECCO 临床2期活动性重度克罗恩病 180 Laquinimod 1 mg AUC = NC h · ng/mL (mean(SD), NC) 积极 2014-02-01 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://academic.oup.com/ecco-jcc/article/8/Supplement_1/S226/369200 https://synapse.zhihuiya.com/clinical-result-detail/aaa0d358e2583552e5822a8a23a24202 DOP059 Reduction of fecal calprotectin levels and relationship to clinical parameters in the phase 2 study of laquinimod for the treatment of active moderate to severe Crohn's disease NCT00737932 ECCO 临床2期活动性重度克罗恩病 180 Laquinimod 0.5 mg 临床缓解 = increased % 积极 2014-02-01 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://academic.oup.com/ecco-jcc/article/8/Supplement_1/S43/370760 https://synapse.zhihuiya.com/clinical-result-detail/2a59d839a529e424a58e2805ede9d89d DOP059 Reduction of fecal calprotectin levels and relationship to clinical parameters in the phase 2 study of laquinimod for the treatment of active moderate to severe Crohn's disease NCT00737932 ECCO 临床2期活动性重度克罗恩病 180 Laquinimod 1.0 mg 临床缓解 = increased % 积极 2014-02-01 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://academic.oup.com/ecco-jcc/article/8/Supplement_1/S43/370760 https://synapse.zhihuiya.com/clinical-result-detail/2a59d839a529e424a58e2805ede9d89d Disease progression in relapse-free patients treated with laquinimod. - ECTRIMS 临床3期疾病进展 - Laquinimod Disability progression = 38.9 % 积极 2013-09-30 Bristol Myers Squibb Co. | MedImmune LLC | Ono Pharmaceutical Co., Ltd. | Neuren Pharmaceuticals Ltd. | Teva Italia Srl | Merck Serono SA | Sanofi | Gilead House | DioGenix, Inc. | Teva Pharmaceutical Industries Ltd. | Acorda Therapeutics, Inc. | Klein Buendel, Inc. | Avanir Pharmaceuticals, Inc. | Hoffmann-La Roche, Inc. | Janssen Pharmaceuticals, Inc. | Elan Corp. Plc | Daiichi Sankyo Co., Ltd. | Bayer AG | Medscape, LLC | Orasi Medical, Inc. | Alexion Pharmaceuticals, Inc. | Celgene Corp. | Nuron Biotech, Inc. | Questor Technology, Inc. | Revalesio Corp. | Novartis AG | Receptos LLC | Apotek K-24 | Merck & Co., Inc. | BioMS Technology Corp. | Genentech, Inc. | Eli Lilly & Co. | Genzyme Corp. | Teva Pharmaceutical KK | Biogen, Inc. | XenoPort, Inc. | Allozyne, Inc. 拉喹莫德 https://journals.sagepub.com/doi/epub/10.1177/1352458513502429 https://synapse.zhihuiya.com/clinical-result-detail/25e52a5ae5aa252a255d8e2d285aa2e9 A RANDOMIZED CONTROLLED STUDY OF LAQUINIMOD IN ACTIVE LUPUS NEPHRITIS PATIENTS IN COMBINATION WITH STANDARD OF CARE - EULAR 临床2期狼疮性肾炎 46 Laquinimod 0.5mg/day Adverse Event: common adverse events (AEs) = There was no difference among the three treatment groups in the frequency of common adverse events (AEs) including infections - 2013-06-12 - 拉喹莫德 https://scientific.sparx-ip.net/archiveeular/?view=2&c=a&item=2013LB0003 https://synapse.zhihuiya.com/clinical-result-detail/3d8434523d5552a522550e22e2ee0222 A RANDOMIZED CONTROLLED STUDY OF LAQUINIMOD IN ACTIVE LUPUS NEPHRITIS PATIENTS IN COMBINATION WITH STANDARD OF CARE - EULAR 临床2期狼疮性肾炎 46 Laquinimod 1mg/day Adverse Event: common adverse events (AEs) = There was no difference among the three treatment groups in the frequency of common adverse events (AEs) including infections - 2013-06-12 - 拉喹莫德 https://scientific.sparx-ip.net/archiveeular/?view=2&c=a&item=2013LB0003 https://synapse.zhihuiya.com/clinical-result-detail/3d8434523d5552a522550e22e2ee0222 Comparison of Early and Delayed Oral Laquinimod in Patients with Relapsing-Remitting Multiple Sclerosis: Effects on Disability Progression at 36 Months in the ALLEGRO Trial (S41.004) NCT00509145 AAN 临床3期复发-缓解型多发性硬化 864 Laquinimod Disability progression = 11.8 % 积极 2013-02-12 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://www.neurology.org/doi/full/10.1212/WNL.80.7_supplement.S41.004 https://synapse.zhihuiya.com/clinical-result-detail/05ea2202352824285e34380d9e2aa28a Comparison of Early and Delayed Oral Laquinimod in Patients with Relapsing-Remitting Multiple Sclerosis: Effects on Disability Progression at 36 Months in the ALLEGRO Trial (S41.004) NCT00509145 AAN 临床3期复发-缓解型多发性硬化 864 Laquinimod Disability progression = 16.7 % 积极 2013-02-12 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://www.neurology.org/doi/full/10.1212/WNL.80.7_supplement.S41.004 https://synapse.zhihuiya.com/clinical-result-detail/05ea2202352824285e34380d9e2aa28a P379 Safety and efficacy of laquinimod in inducing clinical and biochemical improvement in active Crohn's disease: Results of an exploratory trial - ECCO 临床2期克罗恩病 117 Laquinimod 0.5 mg Adverse Event: abdominal pain = most common AEs were abdominal pain 积极 2013-02-01 University of Western Ontario 拉喹莫德 https://academic.oup.com/ecco-jcc/article/7/Supplement_1/S161/411616 https://synapse.zhihuiya.com/clinical-result-detail/839ed8e4dea8aee5a55d022e52805452 P379 Safety and efficacy of laquinimod in inducing clinical and biochemical improvement in active Crohn's disease: Results of an exploratory trial - ECCO 临床2期克罗恩病 117 Laquinimod 1 mg Adverse Event: abdominal pain = most common AEs were abdominal pain 积极 2013-02-01 University of Western Ontario 拉喹莫德 https://academic.oup.com/ecco-jcc/article/7/Supplement_1/S161/411616 https://synapse.zhihuiya.com/clinical-result-detail/839ed8e4dea8aee5a55d022e52805452 Pooled Analyses from the ALLEGRO and BRAVO Trials on the Safety and Tolerability of Laquinimod as a Multiple Sclerosis Treatment (P04.132) - AAN 临床3期多发性硬化症 - Laquinimod 0.6mg once daily AE = 81.8 % - 2012-04-23 Teva Pharmaceutical Industries Ltd. 拉喹莫德 https://www.neurology.org/doi/full/10.1212/WNL.78.1_supplement.P04.132 https://synapse.zhihuiya.com/clinical-result-detail/5de30dee3d254a235232aa522e553282 Pooled Analyses from the ALLEGRO and BRAVO Trials on the Safety and Tolerability of Laquinimod as a Multiple Sclerosis Treatment (P04.132) - AAN 临床3期多发性硬化症 - Oral placebo AE = 76.2 % - 2012-04-23 Teva Pharmaceutical Industries Ltd. 拉喹莫德 https://www.neurology.org/doi/full/10.1212/WNL.78.1_supplement.P04.132 https://synapse.zhihuiya.com/clinical-result-detail/5de30dee3d254a235232aa522e553282 Clinical Efficacy of Laquinimod for the Treatment of Multiple Sclerosis; Pooled Analyses from the ALLEGRO and BRAVO Phase III Trials (S01.007) - AAN 临床3期多发性硬化症 2437 Laquinimod PBVC = -0.835 % 积极 2012-04-23 Teva Pharmaceutical Industries Ltd. 拉喹莫德 https://www.neurology.org/doi/full/10.1212/WNL.78.1_supplement.S01.007 https://synapse.zhihuiya.com/clinical-result-detail/a250a8a2e5525aa93282e082e50e250d Clinical Efficacy of Laquinimod for the Treatment of Multiple Sclerosis; Pooled Analyses from the ALLEGRO and BRAVO Phase III Trials (S01.007) - AAN 临床3期多发性硬化症 2437 Placebo PBVC = -1.188 % 积极 2012-04-23 Teva Pharmaceutical Industries Ltd. 拉喹莫德 https://www.neurology.org/doi/full/10.1212/WNL.78.1_supplement.S01.007 https://synapse.zhihuiya.com/clinical-result-detail/a250a8a2e5525aa93282e082e50e250d Placebo-controlled trial of oral laquinimod for multiple sclerosis NCT00509145 Pubmed 临床3期多发性硬化症 1106 laquinimod ARR = 0.30 Unit (SE, 0.02) 积极 2012-03-15 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://pubmed.ncbi.nlm.nih.gov/22417253/ https://synapse.zhihuiya.com/clinical-result-detail/28a52e24e8285a03a8a855aa0e922d5a Placebo-controlled trial of oral laquinimod for multiple sclerosis NCT00509145 Pubmed 临床3期多发性硬化症 1106 Placebo ARR = 0.39 Unit (SE, 0.03) 积极 2012-03-15 Teva Branded Pharmaceutical Products R&D LLC 拉喹莫德 https://pubmed.ncbi.nlm.nih.gov/22417253/ https://synapse.zhihuiya.com/clinical-result-detail/28a52e24e8285a03a8a855aa0e922d5a 12、转化医学研究亮点主题期刊/会议出版日期药物适应症机构 Safety and Biodistribution of Topical Laquinimod, an Immunomodulator Targeting Aryl Hydrocarbon Receptor: The LION Study **总结：拉喹莫德滴眼液（LAQ）的安全性及生物分布研究（LION研究）** **目的**：评估靶向芳香烃受体的免疫调节剂LAQ滴眼液作为潜在替代激素的抗炎疗法的安全性、耐受性及眼内分布。 **方法**：斯坦福大学Byers眼科研究所开展的I期临床试验（NCT06161415）。10例计划接受玻璃体切除术的非感染性眼病患者，术前14天按序分配至0.6 mg、1.2 mg或1.8 mg每日LAQ剂量组（每组3-4例），逐步递增剂量。通过术前检查、多模态成像及样本（房水、玻璃体、血浆）LAQ浓度分析评估安全性和药代动力学。 **结果**：LAQ在所有剂量下均耐受良好，仅3例不良事件与药物无关。LAQ在眼内及血浆中呈现剂量依赖性分布：房水浓度显著高于玻璃体（均值508.5–3640.0 ng/mL vs. 6.89–38.50 ng/mL），血浆浓度（153.4–563.5 ng/mL）处于安全范围。 **结论**：LAQ滴眼液（0.6–1.8 mg/日）安全且可有效渗透至眼后段，支持其用于炎症性眼病的进一步研究。 **注**：商业利益披露见原文附录。（字数：348） 1期临床研究 Ophthalmol Sci 2026-06-01 拉喹莫德眼部疾病 Stanford University Efficacy and safety of disease-modifying oral drugs in treatment of relapsing-remitting multiple sclerosis: systematic review and network meta-analysis - 2/3期临床研究 Front Immunol 2026-03-16 西尼莫德 | 盐酸芬戈莫德 | 克拉屈滨 | Ponesimod | 富马酸二甲酯 | 拉喹莫德复发-缓解型多发性硬化河北医科大学 Laquinimod attenuates oxidative stress-induced mitochondrial injury and alleviates intervertebral disc degeneration by inhibiting the NF-κB signaling pathway 本研究发现拉奎尼莫德通过抑制NF-κB信号通路，减轻氧化应激诱导的线粒体损伤，缓解椎间盘退变。拉奎尼莫德显著降低了核心脊髓细胞中氧化应激诱导的炎症反应，下调了分解酶的表达，并通过抑制NF-κB信号通路显著增强了细胞外基质的降解。此外，拉奎尼莫德还改善了线粒体功能状态，并减少了细胞凋亡。在大鼠体内实验中，拉奎尼莫德显著减轻了针刺诱导的椎间盘退变。这些发现为拉奎尼莫德作为氧化应激诱导的椎间盘退变治疗的潜力提供了新的见解。药物发现/临床前 Int Immunopharmacol 2024-04-01 拉喹莫德椎间盘退化 School of Public Health, Anhui Medical University, Hefei, Anhui 230000, China. Safety and efficacy of laquinimod for Huntington's disease (LEGATO-HD): a multicentre, randomised, double-blind, placebo-controlled, phase 2 study 本研究旨在评估拉奎尼莫在改善运动功能和减少亨廷顿病患者尾状核体积损失方面的安全性和有效性。研究结果显示，拉奎尼莫在改善运动症状方面未显示出显著效果，但在52周时与安慰剂相比显著减少了尾状核体积损失。拉奎尼莫耐受性良好，未发现新的安全问题。研究未能确定拉奎尼莫治疗更长时间是否能产生可检测和有意义的临床改变。 2期临床研究 Pubmed 2024-03-01 拉喹莫德亨廷顿舞蹈病 George Huntington Institute | Novartis Pharmaceuticals, East Hanover, NJ, USA | School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Clayton, VIC, Australia | Novo Nordisk, Bagsvaerd, Denmark | Research and Development, Teva Pharmaceutical Industries, Petah Tikva, Israel | Prilenia Therapeutics, Herzliya, Israel | Department of Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany | Department of Clinical Radiology, University of Münster, Münster, Germany Laquinimod combined with an essential fatty acid-rich diet enhances the neuroprotective effect in an acute rodent model of Huntington's disease 本研究发现，拉奎尼莫联合富含必需脂肪酸的饮食能够增强对亨廷顿病急性啮齿动物模型的神经保护作用。拉奎尼莫作为一种炎症调节剂，能够促进脑源性神经营养因子的表达，降低血清IL-6水平，而富含必需脂肪酸的饮食已被证实对抗喹啉酸（QA）诱导的纹状体损伤具有神经保护作用。本研究旨在探究拉奎尼莫与富含必需脂肪酸的饮食联合应用是否能增强它们在QA诱导的亨廷顿病模型中的神经保护效果。研究结果显示，联合治疗具有协同作用，能够显著减少旋转行为、改善横梁平衡表现，并显著减少纹状体氧化损伤。因此，本研究展示了拉奎尼莫联合富含必需脂肪酸的饮食在亨廷顿病急性模型中诱导的神经保护效果。药物发现/临床前 SFN 2022 2022-11-15 拉喹莫德亨廷顿舞蹈病 Neurofarmacología Mol. y Nanotecnología, Inst. Nacional de Neurología y Neurocirugía, Mexico, Mexico | Alimentos y Biotecnología, Univ. Nacional Autónoma de México, Ciudad de México, Mexico | Cinvestav-IPN, Mexico 07300 DF, Mexico | Neurofarmacología Mol. y Nanotecnología, Inst. Nacional de Neurología y Neurocirugía, Ciudad de México, Mexico | Cinvestav, Ciudad de México, Mexico | Inst. Nacional De Neurología Y Neurocirugía, Mexico, Mexico Deep Learning Prediction of Response to Disease Modifying Therapy in Primary Progressive Multiple Sclerosis - 3期临床研究 ACTRIMS 2022 2022-05-16 奥瑞利珠单抗 | 利妥昔单抗 | 拉喹莫德原发性进行性多发性硬化 McGill University Deep Learning Prediction of Response to Disease Modifying Therapy in Primary Progressive Multiple Sclerosis (P1-1.Virtual) - 2期临床研究 AAN 2022 2022-05-03 奥瑞利珠单抗 | 利妥昔单抗 | 拉喹莫德原发性进行性多发性硬化 McGill University CONCERTO: A randomized, placebo-controlled trial of oral laquinimod in relapsing-remitting multiple sclerosis. 本研究是一项关于口服拉奎尼莫治疗复发-缓解型多发性硬化症（RRMS）的随机安慰剂对照试验。研究旨在评估拉奎尼莫在RRMS患者中的疗效、安全性和耐受性。研究结果显示，拉奎尼莫0.6毫克剂量对3个月确认的残疾进展（CDP）未能达到显著效果，但在脑体积变化方面表现出40%的减少。拉奎尼莫在临床复发和磁共振成像（MRI）结果上仅有轻微显著效果，并且耐受性良好。该研究为临床治疗提供了一定的参考价值。ClinicalTrials.gov注册号：NCT01707992。 3期临床研究 Mult Scler 2021-08-11 拉喹莫德复发-缓解型多发性硬化 Teva Branded Pharmaceutical Products R&D LLC A longitudinal PET study to assess the state of microglia activation in a Phase 2 study of Laquinimod as a treatment for Huntington’s disease (LEGATO-HD) 该研究使用PET技术对亨廷顿病患者进行了长期观察，评估了拉奎尼莫在治疗亨廷顿病（HD）的第二阶段研究（LEGATO-HD）中对微胶质细胞激活状态的影响。研究结果表明，拉奎尼莫治疗对HD患者的区域微胶质细胞激活没有显著影响。这一结论提示拉奎尼莫可能不会影响HD患者的微胶质细胞激活状态。 2期临床研究 MDS 2020 2020-09-12 拉喹莫德 Huntington’s disease - A randomized, placebo-controlled, phase 2 trial of laquinimod in primary progressive multiple sclerosis 本研究是一项随机、安慰剂对照的2期试验，旨在评估拉奎尼莫在原发性进行性多发性硬化症（PPMS）患者中的疗效、安全性和耐受性。研究结果显示，拉奎尼莫0.6毫克剂量在48周内未能显著减少PPMS患者的脑容积损失。然而，该剂量能够减少新的T2脑病变的数量。拉奎尼莫治疗组的不良事件发生率较高，但总体耐受性良好。因此，本研究提供了拉奎尼莫0.6毫克在PPMS患者中未能显著改善脑容积损失的一级证据。ClinicalTrials.gov标识符：NCT02284568。 2期临床研究 Neurology 2020-08-25 拉喹莫德原发性进行性多发性硬化 - Quantitative Motor (Q-Motor) Assessments Suggest a Beneficial Central Effect of Laquinimod in a Phase II Study in Huntington Disease (LEGATO-HD) LEGATO-HD研究评估了拉奎尼莫在亨廷顿病（HD）治疗中的作用。虽然评估运动症状的主要终点UHDRS-TMS未显示出变化，但次要终点基于基线改变的尾状核体积有所改善。研究采用Q-Motor评估，包括手指运动、手部运动、握力和步态等多个方面。结果显示，0.5mg剂量组的手指运动表现出改善，1mg剂量组也呈现出积极趋势。其他参数如手部运动和步态也有一定程度的改善。总体而言，拉奎尼莫在Q-Motor评估中显示出对HD患者有益的中枢效应，支持了影像学变化的生物学相关性。需要谨慎对待这些结果，但这些观察结果表明了拉奎尼莫在LEGATO-HD研究中具有未知临床意义的中枢益处效应。 2期临床研究 MDS 2019 2019-09-22 拉喹莫德亨廷顿舞蹈病 - Brain MRI Volume Changes after 12 months laquinimod treatment of Huntington disease (LEGATO-HD) 本研究旨在探讨拉奎尼莫治疗亨廷顿病12个月后对大脑MRI体积的影响。研究发现，使用1.0毫克拉奎尼莫治疗的患者相比安慰剂组，在52周时出现了较少的尾状核体积损失（p = 0.0002）。此外，0.5毫克和1.0毫克拉奎尼莫治疗组在所有预定亚组中均显示出对大脑体积损失的一致减少效果（所有p < 0.01）。然而，拉奎尼莫组的大脑体积减少并未与临床结果相关联。这表明拉奎尼莫对亨廷顿病患者的大脑体积损失具有一定的减缓作用。 2期临床研究 MDS 2019 2019-09-22 拉喹莫德亨廷顿舞蹈病 Teva Branded Pharmaceutical Products R&D LLC Magnetic Resonance Spectroscopy Evaluation of Neuronal Integrity and Astrocytosis in a Phase 2 Study of Laquinimod as a Treatment for Huntington Disease (LEGATO-HD) 本研究使用磁共振波谱技术评估了拉奎尼莫在亨廷顿病治疗中的神经元完整性和星形胶质增生的效果。研究发现，拉奎尼莫治疗组患者的星形胶质标志物肌醇在52周时显著降低，而对照组患者则呈增加趋势。这表明拉奎尼莫治疗能够减少星形胶质增生，与其已知的体外和体内对神经炎症的影响一致。该研究为拉奎尼莫在亨廷顿病治疗中的神经保护作用提供了实验支持。 2期临床研究 MDS 2019 2019-09-22 拉喹莫德亨廷顿舞蹈病 - Laquinimod effectively inhibits development of EAU and its associated immune effector responses Laquinimod (LAQ)有效抑制了EAU的发展及其相关的免疫效应。研究目的是测试LAQ对实验性自身免疫性葡萄膜炎（EAU）及相关免疫反应的疗效。实验中，使用C57BL/6J小鼠通过免疫接种诱导EAU，然后给予LAQ或PBS治疗。结果显示，LAQ从免疫接种后第0天开始治疗完全抑制了EAU的诱导，而从第7天开始治疗也显著抑制了相关免疫反应和降低了EAU得分。此研究结果于2019年ARVO年会上报告。药物发现/临床前 ARVO 2019 2019-07-01 拉喹莫德葡萄膜炎 NEI/NIH The Efficacy and Safety Results of Laquinimod as a Treatment for Huntington Disease (LEGATO-HD) (S16.007) 文中介绍了拉喹奈莫在亨廷顿病治疗中的功效和安全性结果。拉喹奈莫在早期亨廷顿病患者中减少了尾状核和其他脑区的体积损失，但在LEGATO-HD研究中并未观察到改善临床结果。研究对比了三个不同剂量的拉喹奈莫与安慰剂，发现了在多发性硬化症研究中出现的心血管安全性问题。尽管在LEGATO-HD中未发现类似问题，但Teva公司为了安全起见停止了1.5mg剂量的使用，并继续评估0.5mg和1.0mg的剂量。研究结果显示，拉喹奈莫未能达到改善UHDRS-TMS的主要终点，但达到了CV损失的次要终点。在MRI探索性指标中发现了拉喹奈莫治疗组与安慰剂组之间的治疗效果差异。拉喹奈莫耐受良好，安全性良好且无新的安全问题。 2期临床研究 AAN 2019 2019-04-09 拉喹莫德亨廷顿舞蹈病 George-Huntington-Institute Muenster Germany Therapeutic effects of laquinimod on Huntington's disease mice - 药物发现/临床前 SFN 2018 2018-11-03 拉喹莫德亨廷顿舞蹈病 Human Genet. Dept., Emory Univ., Atlanta, GA Legato-HD Study: A Phase 2 Study Assessing theEfcacy and Safety of Laquinimod as a Treatment forHuntington Disease 该研究是一项关于拉奎尼莫在亨廷顿病治疗中的有效性和安全性的二期研究。研究结果表明，亨廷顿病患者需要有效的治疗来减轻症状和神经退行性。拉奎尼莫可能成为潜在的治疗方法。研究由Teva Pharmaceuticals Ltd赞助，合作伙伴包括HSG和EHDN，已在临床试验注册。拉奎尼莫是一种口服小分子药物，已被证明可以通过血脑屏障并调节与亨廷顿病相关的炎症途径。研究包括两个剂量的拉奎尼莫与安慰剂的比较，预计将于2018年6月完成。研究结果将在会议上公布。 2期临床研究 ANA 2018 2018-10-05 拉喹莫德 - NYU Langone Medical Center | University of British Columbia | Imperial College London | Teva Pharmaceutical Industries Ltd. | UCL Institute of Neurology | University of Tuebingen ARPEGGIO: a placebo-controlled trial of oral laquinimod in primary progressive multiple sclerosis (S8.003) ARPEGGIO是一项关于口服拉奎尼莫在原发性进行性多发性硬化症（PPMS）中的安慰剂对照试验（S8.003）。拉奎尼莫是一种新型药物，可以调节外周（树突状细胞和单核细胞）和中枢神经系统（微胶质细胞和星形胶质细胞）的先天免疫细胞系。这项研究将为拉奎尼莫作为PPMS潜在治疗药物的理解提供信息。研究由Teva Pharmaceutical Industries支持。研究设计为ARPEGGIO是一项正在进行的2期随机、双盲、安慰剂对照研究，旨在评估口服一日一次的拉奎尼莫在PPMS患者中的疗效、安全性和耐受性。预计数据库锁定日期为2017年11月8日。 2期临床研究 AAN 2018 2018-04-10 拉喹莫德原发性进行性多发性硬化 VU Medical Center Maarssen Netherlands | Centre for Neuroscience and Trauma, QMUL, University College London London United Kingdom Direct neuroprotective effect of laquinimod on glutamate excitotoxicity in experimental multiple sclerosis (P2.366) 该研究发现，laquinimod对实验性多发性硬化症（EAE）小鼠的谷氨酸兴奋毒性具有直接的神经保护作用。研究表明，laquinimod能够通过调节IL-1β-miR-142-3p-GLAST信号通路，减轻EAE小鼠小脑的谷氨酸能神经元损伤。实验结果显示，laquinimod能够恢复GLAST的表达水平，改善突触后兴奋性电流的动力学特性，而不影响IL-1β和miR-142-3p的水平，也不干预炎症相关机制。这一发现为laquinimod作为潜在的神经保护药物提供了新的证据。药物发现/临床前 AAN 2017 2017-04-18 拉喹莫德多发性硬化症 Tor Vergata University of Rome Rome Italy Laquinimod is a potent arylhydrocarbon receptor dependent activator of natural killer cells (P2.355) Laquinimod是一种强效的芳香烃受体依赖性天然杀伤细胞激活剂（P2.355）。研究背景：自然杀伤（NK）细胞是大颗粒淋巴细胞，对病毒感染和肿瘤细胞提供先天免疫监视。最近的研究强调了它们直接或间接调节适应性免疫反应的潜力，后者主要通过NK细胞与树突状细胞的双向交流。结论：AhR介导的NK细胞激活对于维持laquinimod改善中枢神经系统自身免疫的疗效具有重要意义。研究支持：该项目得到Teva Pharmaceutical Industries Ltd的支持。设计：分析laquinimod的NK细胞激活特性，包括在B16F10黑色素瘤小鼠模型中对肿瘤细胞杀伤和在实验性自身免疫性脑脊髓炎（EAE）中对免疫调节的影响。目的：本研究旨在探讨laquinimod的免疫调节特性，一种对多发性硬化症具有疾病修饰活性的喹啉-3-羧酰胺衍生物，是否部分通过NK细胞激活介导，以及这是否依赖于芳香烃受体（AhR）。结果：Laquinimod直接激活NK细胞，这需要一个功能性的AhR。在B16F10黑色素瘤转移模型中，laquinimod治疗显著减少了肺转移的数量，而来自laquinimod治疗小鼠的NK细胞比来自水处理对照组的NK细胞更有效地杀死B16F10黑色素瘤细胞。Laquinimod在EAE中的保护作用部分依赖于NK细胞。在一个包括2D2 T细胞和骨髓来源的DCs的三重共培养系统中，来自laquinimod治疗小鼠的NK细胞抑制了针对MOG 35-55的T细胞增殖，比来自水处理对照组的分选NK细胞显著更好。这种NK细胞的抑制作用需要与聚病毒阳性DCs的直接细胞接触，并且出乎意料地并没有增加DC的杀伤，而是减少了MHC-II抗原呈递。药物发现/临床前 AAN 2017 2017-04-18 拉喹莫德 - Teva Pharmaceutical Industries Ltd. | Department of Neuropathology Laquinimod targets the aryl hydrocarbon receptor (AhR) pathway in periphery and brains of naïve and EAE mice (P2.365) Laquinimod是一种每日口服的治疗药物，目前正在临床试验中用于复发-缓解型和原发性进行性多发性硬化（MS）以及亨廷顿病（HD）。研究表明，Laquinimod在外周和中枢神经系统中诱导了AhR通路，对免疫细胞具有组织特异性影响。AhR在动物模型中对Laquinimod疗效起到关键作用，进一步研究正在进行以加深我们对这些机制及其在MS和HD治疗效果中的意义的理解。研究结果显示，Laquinimod在EAE和原始小鼠中不同程度地调节了与AhR相关的基因，同时也在NF-κB通路中调节了多个与疾病相关的基因。此外，Laquinimod在脑部特异性地减少了促炎单核细胞（M1）基因的表达，与先前的报告一致，证明了Laquinimod诱导了对中枢神经系统的M1细胞浸润的减少。药物发现/临床前 AAN 2017 2017-04-18 拉喹莫德原发性进行性多发性硬化 | 亨廷顿舞蹈病 Immuneering Corp. | Teva Pharmaceutical Industries Netanya Israel Laquinimod modulates central nervous system inflammation via the aryl hydrocarbon receptor and is effective in the chronic NOD progressive EAE model (P2.353) Laquinimod通过芳烃受体调节中枢神经系统炎症，在慢性NOD进行性EAE模型中有效。Laquinimod是一种一天一次的口服小分子药物，目前在临床上用于治疗多发性硬化症（MS）和亨廷顿病。最近，我们证明了AhR介导了Laquinimod对实验性自身免疫性脑脊髓炎（EAE）的抑制作用。研究显示，在DCs和星形胶质细胞中的AhR信号介导了Laquinimod对中枢神经系统炎症的抑制作用。研究设计采用条件性基因敲除小鼠来确定Laquinimod抑制EAE的细胞靶点。研究结果表明，Laquinimod对EAE的保护作用在AHRDC和AHRAst小鼠中丧失。另外，Laquinimod在NOD进行性EAE模型中也显示出了治疗效果。药物发现/临床前 AAN 2017 2017-04-18 拉喹莫德多发性硬化症 | Huntington’s disease Teva Pharmaceutical Industries Ltd. Laquinimod arrests experimental autoimmune encephalomyelitis by activating the aryl hydrocarbon receptor Laquinimod通过激活芳烃受体阻止实验性自身免疫脑脊髓炎。Laquinimod是一种口服药物，目前正在评估其治疗复发性、缓解性和原发性进行性多发性硬化症以及亨廷顿病的疗效。研究表明，Laquinimod对外周先天免疫系统和中枢神经系统内的细胞均有影响，但其确切作用机制尚未完全阐明。我们研究了Laquinimod治疗小鼠后的基因表达情况，并展示了芳烃受体激活后下游基因的诱导。本文探讨了芳烃受体在Laquinimod治疗实验性自身免疫脑脊髓炎中的作用，并证明芳烃受体是该模型中Laquinimod的分子靶点。靶点 Proc Natl Acad Sci U S A 2016-09-26 拉喹莫德多发性硬化症 Teva Pharmaceutical Laquinimod decreases Bax expression and reduces caspase-6 activation in neurons Laquinimod 是一种免疫调节化合物，在多发性硬化的临床试验中显示出神经保护的益处。它能改善人体白质和灰质损伤，并预防多发性硬化动物模型中的轴突退变。轴突损伤和白质丢失是不同神经退行性疾病共同特征。在分子水平上，caspase-6 活化在轴突退变中起着重要作用。我们的研究表明，Laquinimod 能减少Bax的表达，减轻神经元中caspase-6的活化。这是一种间接效应，不是通过直接抑制酶来实现。Laquinimod 能直接下调与轴突退变相关的神经元凋亡途径，除了其已知对中枢神经系统星形胶质细胞和微胶质细胞的影响。它靶向了与亨廷顿病的病理发病机制相关的途径，支持了Laquinimod 可能提供临床益处的假说。药物发现/临床前 Pubmed 2016-09-01 拉喹莫德神经退行性疾病 Centre for Molecular Medicine and Therapeutics (CMMT), CFRI, Department of Medical Genetics, University of British Columbia, 950 West 28(th) Avenue, Vancouver, BC, V5Z 4H4, Canada. Long-Term Follow-Up of Laquinimod 0.6 mg in Patients with Relapsing-Remitting Multiple Sclerosis 2 (P3.087) 长期随访Laquinimod 0.6毫克对于复发缓解型多发性硬化患者的疗效和安全性。Laquinimod 0.6毫克每日可使年复发率（ARR）减少21％，3个月确认的残疾进展（CDP）减少34％。安全性包括头痛、腹痛、背部/颈部疼痛和阑尾炎。在治疗的最初几个月出现了无症状、轻微、非进行性的实验室变化。研究目的是评估Laquinimod治疗多达10年的患者的长期疗效和安全性。疗效评估涉及Laquinimod治疗的患者，安全性评估涉及了'累积'和'≥2年'队列的患者。结果显示，延迟开始治疗的患者在开放标签阶段ARR较安慰剂对照阶段有所减少；早期开始治疗的患者继续表现出比延迟开始治疗的患者更低的ARR，并保持了在安慰剂对照阶段观察到的明显CDP效应。安全性方面，早期终止由于不良事件（AEs）在累积队列中发生在7％的患者中，而在≥2年队列中发生在＜3％的患者中。总体而言，Laquinimod的疗效和安全性在长达10年的随访中得到了维持。 3期临床研究 AAN 2016 2016-04-05 拉喹莫德复发-缓解型多发性硬化 Teva Pharmaceutical Industries Ltd. Laquinimod Disability Progression Effects Are Maintained with Increasingly Rigorous Confirmation Time Intervals (P3.069) 口服拉奎尼莫每日0.6毫克（QD）在ALLEGRO和BRAVO试验中表现出一致的3个月确认残疾进展（CDP）的减少。为了探索拉奎尼莫对CDP的持久效果，使用了越来越严格的残疾确认时间间隔进行了额外分析。结果显示，拉奎尼莫对6、9和12个月的CDP的治疗效果均得到维持。拉奎尼莫对减少残疾进展的深远影响得到了一致的证实。 3期临床研究 AAN 2016 2016-04-05 拉喹莫德 - San Raffaele Scientific Institute and University Vita-Salute Milan Italy Effects of laquinimod on microglia and monocytes following traumatic brain injury - 药物发现/临床前 SFN 2015 2015-10-17 拉喹莫德创伤性脑损伤 Cleveland Clin. A phase II study of laquinimod in Crohn's disease 该研究是一项关于拉奎尼莫在克罗恩病治疗中的Ⅱ期研究。研究旨在评估拉奎尼莫作为诱导治疗在活动性中度至重度克罗恩病患者中的安全性和有效性。研究结果显示，拉奎尼莫在0.5mg剂量下对缓解和临床反应有一定效果，且安全耐受。然而，1.0mg剂量显示较少益处，更高剂量未见效果。该研究为克罗恩病治疗提供了新的治疗选择。 2期临床研究 Pubmed 2015-08-01 拉喹莫德克罗恩病 Robarts Research Institute | Teva Pharmaceuticals, Netanya, Israel | Teva Pharmaceuticals, Frazer, Pennsylvania, USA | Academic Medical Center | Chiasma Pharma, Jerusalem, Israel Laquinimod regulates inflammatory gene induction in a human model of reactive astrogliosis (S20.005) Laquinimod是一种口服免疫调节剂，正在进行复发-缓解型多发性硬化症（MS）的III期临床试验。研究发现，Laquinimod在人体反应性星形胶质增生模型中显著影响促炎基因表达。Laquinimod通过干扰转录因子NF-κB的核转位来发挥作用。研究结果表明，Laquinimod能够限制星形胶质细胞产生细胞毒性和促炎介质，促进血脑屏障完整性，这些效应是通过抑制NFκB核转位介导的。这些发现揭示了Laquinimod在人体模型中作为反应性星形胶质增生的强效调节剂。药物发现/临床前 AAN 2015 2015-04-06 拉喹莫德 - Department of Neurology Icahn School of Medicine at Mount Sinai New York NY United States Laquinimod suppresses CNS autoimmunity by activation of natural killer cells (P1.161) 该研究发现拉奎尼莫在MOG35-55免疫的C57BL/6小鼠中通过激活自然杀伤细胞(NK细胞)来抑制中枢神经系统自身免疫。拉奎尼莫能显著减少复发-缓解型多发性硬化患者的残疾进展和脑萎缩。实验结果显示，拉奎尼莫能增加CD69+ NK细胞的百分比，并在NK细胞上特异性上调激活受体TACTILE、DNAM-1和NKG2D的表达。拉奎尼莫介导的NK细胞激活显著提高了对B16F10黑色素瘤细胞的杀伤能力，并在体外对IL-12和IL-18刺激产生细胞因子。此外，拉奎尼莫治疗的NK细胞显著抑制了MOG35-55诱导的T细胞增殖。研究结果表明，拉奎尼莫诱导NK细胞激活有助于抑制中枢神经系统自身免疫。在多发性硬化中，NK细胞功能受损，而拉奎尼莫可能恢复NK细胞功能。药物发现/临床前 AAN 2015 2015-04-06 拉喹莫德中枢神经系统狼疮血管炎 Teva Pharmaceutical Industries Netanya Israel | Department of Neuropathology, University Medical Center Goettingen Goettingen Germany Baseline characteristics of patients enrolled in CONCERTO - a study of 0.6 and 1.2 mg/day oral laquinimod for relapsing-remitting multiple sclerosis (P7.216) CONCERTO研究是一项关于0.6和1.2毫克/天口服拉奎尼莫治疗复发-缓解型多发性硬化症（RRMS）的研究。研究旨在评估拉奎尼莫在0.6毫克和1.2毫克每日剂量与安慰剂相比对RRMS患者的疗效、安全性和耐受性。研究结果将有助于测试拉奎尼莫对3个月确认的残疾进展的影响。研究纳入了1710名来自29个国家的患者，其中68%为女性。研究人群的特征与之前的拉奎尼莫试验人群相似，只是患者年龄稍轻，病程较短。 3期临床研究 AAN 2015 2015-04-06 拉喹莫德复发-缓解型多发性硬化 University Vita-Salute Milan Italy | Teva Pharmaceuticals Netanya Israel | Teva Pharmaceutical Industries Netanya Israel ARPEGGIO: A randomized, placebo-controlled study to evaluate oral laquinimod in patients with primary progressive multiple sclerosis (PPMS) (P7.210) 本研究旨在评估口服拉奎尼莫在原发性进行性多发性硬化症（PPMS）患者中的疗效、安全性和耐受性。拉奎尼莫在RRMS研究中显示出对确认的残疾进展（CDP）的效果更为显著，这表明其作用机制与其他DMTs不同，可能涉及中枢神经退行性过程的调节。本研究将招募约375名符合条件的患者，主要终点为MRI基线至第48周的脑容积变化百分比。预计本研究将于2015年第一季度开始招募。该研究将为拉奎尼莫在治疗进行性多发性硬化症患者中的中枢神经系统实质损失提供信息，这是一种目前没有证明的DMTs的疾病状态。 2期临床研究 AAN 2015 2015-04-06 拉喹莫德原发性进行性多发性硬化 Teva Pharma | Teva Pharmaceutical Industries Ltd. | The University of Colorado | University of Genoa | VU University Medical Centre | Barts and The London School of Medicine and Dentistry Laquinimod prevents disability progression in a model of spontaneous chronic EAE and interferes with the development of follicular helper T-cells. Laquinimod是一种口服免疫调节药物，对多发性硬化症（RRMS）等炎症和神经退行性疾病具有治疗作用。研究表明，Laquinimod可以减少疾病活动和进展。实验显示，Laquinimod能干预Tfh细胞的生成，抑制胚状中心B细胞的成熟和抑制抗-MOG IgG的产生，表明Laquinimod在调节T-B相互作用方面可能有益。研究发现，Laquinimod可降低Tfh细胞和GC B细胞的频率，抑制IL-21的产生，减少MOG IgG抗体的生成，以及改善病情。总之，这些发现表明Laquinimod可能对多发性硬化症的进展有益，对其发展具有重要意义。 3期临床研究 ECTRIMS 2014 2014-09-09 拉喹莫德复发-缓解型多发性硬化 University of California Effect of laquinimod on gray matter and white matter atrophy in relapsing-remitting multiple sclerosis: analysis of the BRAVO phase III trial. 本研究分析了BRAVO三期试验中拉奎尼莫对复发-缓解型多发性硬化灰质和白质萎缩的影响。结果显示，拉奎尼莫显著减少了与安慰剂组相比的灰质和白质萎缩率，且没有伪萎缩的证据。研究方法采用MRI测量了基线至第一年和第二年的灰质和白质体积百分比变化。拉奎尼莫组在第一年和第二年的灰质和白质萎缩率均显著低于安慰剂组。因此，拉奎尼莫对多发性硬化的治疗效果显著，有望成为一种有效的治疗药物。 3期临床研究 ECTRIMS 2014 2014-09-09 拉喹莫德复发-缓解型多发性硬化 McGill University | Teva Pharmaceutical Industries Ltd. | The University of Colorado | NeuroRx Research, Inc. Laquinimod disability progression effects are maintained with increasingly rigorous confirmation time intervals. 本研究使用ALLEGRO和BRAVO试验的数据，分析了口服laquinimod 0.6mg每日一次对6、9和12个月的确认残疾进展的影响。结果表明，laquinimod对残疾进展的效果在所有确认时间间隔内都得到了维持。治疗效果的危险比分别为0.66、0.54、0.53和0.55，p < .005。随着时间的推移，安慰剂组的残疾进展发生率也有所降低。在不同时间点上，基线人口统计学、临床或MRI因素均无法预测残疾进展。因此，laquinimod对残疾进展的效果具有持久性。 3期临床研究 ECTRIMS 2014 2014-09-09 拉喹莫德 - Teva Pharmaceutical Industries Ltd. | The University of Colorado | Vita - Salute San Raffaele University Temporal pattern of laboratory changes with laquinimod treatment. 本研究旨在探讨拉奎尼莫治疗后实验室指标的时间模式。研究发现，0.6mg拉奎尼莫治疗后，肝酶、纤维蛋白原、C-反应蛋白等指标呈现出特定的时间依赖性变化模式。这些变化是非进行性的、无症状的，并且通常在治疗的前几个月出现，然后趋于稳定或恢复到基线水平。研究结果有助于更好地了解拉奎尼莫的作用机制和治疗效果。药物发现/临床前 ECTRIMS 2014 2014-09-09 拉喹莫德 - Teva Pharmaceutical Industries Ltd. | The University of Colorado Ambulation benefit with laquinimod in patients with worsening MS (EDSS over 3) is consistent with reduction in confirmed disability progression. ALLEGRO和BRAVO阶段三研究显示，laquinimod对进行性加重的多发性硬化患者（EDSS大于3）的步行能力有益，有助于减少确认的残疾进展。使用LAQ的患者（pts）在步行功能上有显著效果，包括T25FW测试。与PBO相比，LAQ在EDSS大于3的患者中减少了确认的残疾进展，并且在MSFC方面也表现出了显著效果。在EDSS大于3的患者中，LAQ对T25FW的效果推动了整体MSFC的益处。但在PASAT和9HPT方面，LAQ效果并不明显。研究还发现，使用LAQ进行治疗的患者中，对T25FW效果的影响与残疾进展存在交互作用，PBO组的患者出现残疾进展时，T25FW时间的增加比LAQ组更多。 3期临床研究 ECTRIMS 2014 2014-09-09 拉喹莫德多发性硬化症 Teva Pharmaceutical Industries Ltd. Clinical efficacy of laquinimod 0.6mg once-daily in worsening relapsing-remitting multiple sclerosis defined by baseline EDSS over 3. 本研究旨在评估拉奎尼莫在基线EDSS超过3的加重型复发缓解型多发性硬化症（RRMS）患者中的临床疗效。研究结果显示，拉奎尼莫显著降低了复发率、残疾进展、步态和MRI结果。在基线EDSS超过3的RRMS患者中，拉奎尼莫对ARR、3个月CDP、6个月CDP和MSFC恶化均有显著改善。此外，拉奎尼莫还显著降低了PBVC和新T2病变的累积数量。因此，拉奎尼莫可能是这一患者群体的治疗选择。 3期临床研究 ECTRIMS 2014 2014-09-09 拉喹莫德复发-缓解型多发性硬化 Teva Pharmaceutical Industries Ltd. | The University of Colorado Laquinimod reduces CNS autoimmunity by activation of natural killer cells. 拉奎尼莫德通过激活自然杀伤细胞来降低中枢神经系统自身免疫。拉奎尼莫德是一种口服免疫调节剂，目前正在研究用于治疗复发-缓解型多发性硬化症（MS）。拉奎尼莫德显著降低了MS患者的年复发率、残疾进展和脑萎缩。实验数据显示，拉奎尼莫德对先天和适应性免疫细胞具有免疫调节作用。拉奎尼莫德诱导了类型II髓系细胞。在MS中，NK细胞功能受损，而拉奎尼莫德可能恢复NK细胞功能。我们的研究发现，拉奎尼莫德增加了NK细胞的活化，并提高了其激活受体的表达。此外，拉奎尼莫德改善了NK细胞的效应功能，并且在抑制EAE方面发挥了作用。拉奎尼莫德治疗的有效性分析表明，NK细胞的去除会影响其抑制EAE的功效。药物发现/临床前 ECTRIMS 2014 2014-09-09 拉喹莫德复发-缓解型多发性硬化 Teva Pharmaceutical Industries Ltd. | University Medical Center Goettingen Laquinimod treatment prevents cuprizone-induced demyelination independent of Toll-like receptor signaling via MyD88 and TRIF. Laquinimod（LAQ）治疗可以预防铜丝环诱导的脱髓鞘症，与Toll样受体信号传导无关。研究结果显示，LAQ可以降低多发性硬化患者的残疾进展、脑萎缩和复发率。在小鼠铜丝环诱导的脱髓鞘症模型中，LAQ可以减少脱髓鞘和轴突损伤，通过下调星形胶质细胞NFkB活化来介导这些效应。此外，LAQ对铜丝环诱导的脱髓鞘症具有预防作用，可能不涉及Toll样受体信号传导。这些发现表明LAQ可能在未来的多发性硬化治疗中发挥作用。药物发现/临床前 ECTRIMS 2014 2014-09-09 拉喹莫德多发性硬化症 Teva Pharmaceutical Industries Ltd. | University Medical Center Göttingen FC1.3 Long-term follow-up of laquinimod in patients with relapsing-remitting multiple sclerosis 长期随访显示，口服laquinimod（LAQ）0.6mg每日一次可减少多发性硬化患者的复发相关参数，并显著减少确认的残疾进展和脑容积损失。LAQ的风险包括背部和颈部疼痛、阑尾炎，以及治疗开始后很快出现的轻度无症状实验室变化。长期安全性评估显示，LAQ的安全性和益处在长期随访期间得到维持。长期疗效评估显示，患者继续保持低复发和残疾进展率。那些一直接受LAQ治疗的患者比从安慰剂转换到LAQ的患者有更少的复发和较少的残疾进展。 3期临床研究 ECTRIMS 2014 2014-09-09 拉喹莫德复发-缓解型多发性硬化 - Laquinimod regulates inflammatory gene induction in a human model of reactive astrogliosis. Laquinimod是一种口服免疫调节剂，目前正在进行复发-缓解型多发性硬化的第三阶段临床试验。研究发现，Laquinimod可以通过调节炎症基因在人体反应性星形胶质增生模型中的诱导来影响中枢神经系统炎症。在体外实验中，Laquinimod显著影响了人体反应性星形胶质细胞中的促炎基因表达，包括抑制炎症细胞趋化和迁移，拯救血脑屏障完整性等。这些数据表明，Laquinimod可能通过直接作用于免疫活性的中枢神经系统细胞，限制病变发生，从而在复发-缓解型多发性硬化和其他炎症性中枢神经系统疾病中发挥作用。 3期临床研究 ECTRIMS 2014 2014-09-09 拉喹莫德 - Teva Pharmaceutical Industries Ltd. | Icahn School of Medicine at Mount Sinai Consistent effect of laquinimod on relapse-related and disability progression-related endpoints. 本文总结了一项关于laquinimod（一种口服药物）在多发性硬化治疗中的疗效研究。研究发现，laquinimod能够稳定减少多发性硬化的复发率和残疾进展，并且对患者大脑组织容积损失有一定的治疗效果。研究还发现，不同人群的疗效结果一致，即使效果有一定差异。具体而言，对于患者的性别、年龄、疾病严重程度等特征，laquinimod对复发率和残疾进展均有一定的治疗效果。这项研究为laquinimod的临床应用提供了重要的数据支持。 3期临床研究 ECTRIMS 2014 2014-09-09 拉喹莫德 - Teva Pharmaceutical Industries Ltd. | San Raffaele Scientific Institute and Vita - Salute San Raffaele University, Milan, Italy Laquinimod effect on confirmed disability progression: minimal mediation by relapse or T2 lesions reduction. 口服拉奎尼莫（LAQ）0.6mg QD治疗的RRMS患者在ALLEGRO和BRAVO试验中，3个月和6个月的确认残疾进展（CDP）与安慰剂相比有显著减少。LAQ对神经退行性指标（CDP、脑组织损失）的影响比急性炎症指标（复发、新T2病变）更显著。LAQ对CDP的影响与减少急性炎症事件的机制有所不同，大部分LAQ对残疾减少的效应是由其他机制解释的。LAQ对CDP的影响仅在很小程度上由其对复发的影响介导（PTE=19%和PTE=11%）。在BRAVO试验中，与LAQ相比，IFNβ-1a的效应更多地由复发和新T2病变介导。LAQ对CDP的效应与新T2病变调整后相似（PTE=0%）。 3期临床研究 ECTRIMS 2014 2014-09-09 拉喹莫德 RRMS Teva Pharmaceutical Industries Ltd. | University of Genoa, Genoa, Italy Placebo-controlled trial of oral laquinimod in multiple sclerosis: MRI evidence of an effect on brain tissue damage 在《评估口服拉喹诺膜片预防多发性硬化症进展的ALLEGRO》中，研究了口服拉喹诺膜片对复发-缓解型多发性硬化症（RRMS）患者的疗效。结果显示，与安慰剂相比，拉喹诺膜片治疗组在12和24个月时白质和灰质脑萎缩的速度更慢，且在丘脑萎缩和病变数方面也表现出显著差异。MRI数据显示，拉喹诺膜片可能在初期治疗阶段减少了一些破坏性病理过程。 3期临床研究 Pubmed 2014-08-01 拉喹莫德 - Cornerstone Health Care PA | San Raffaele Scientific Institute Laquinimod Therapy in Multiple Sclerosis: A Comprehensive Review 多发性硬化症（MS）被认为是一种自身免疫性疾病，具有影响中枢神经系统的炎症和神经退行性过程。目前批准用于治疗MS的疾病修饰治疗（DMTs）仅在控制疾病进展方面显示出部分益处，主要是阻碍其炎症成分，而大多数这些治疗的皮下给药方式已经影响了患者的依从性。拉奎尼莫德是一种有前途的新型口服药物，最近在第三期III临床试验中显示出有益的效果，延缓了疾病进展并预防了脑萎缩，表明具有潜在的神经保护作用和良好的安全性。拉奎尼莫德已经在两个III期临床试验中显示出临床疗效和耐受性，第三个III期研究目前正在评估拉奎尼莫德在更高剂量下的安全性和疗效。新型口服治疗如拉奎尼莫德将为患者提供新选择，可以提高患者依从性并改善治疗效果。 3期临床研究 Pubmed 2014-06-01 拉喹莫德多发性硬化症 Department of Neurology, School of Medicine and Biomedical Sciences, State University of New York at Buffalo, New York, USA | Baird MS Center, Jacobs Neurological Institute, Buffalo General Medical Center, New York, USA. Laquinimod Modulates Genes Encoding Cell Migration in Multiple Sclerosis (P1.203) 该研究旨在探究口服Laquinimod治疗复发缓解型多发性硬化症（RRMS）患者可能涉及的分子途径。研究发现Laquinimod通过下调细胞粘附和迁移相关基因，特别是整合素家族成员，影响免疫细胞的迁移能力。这一发现表明Laquinimod可能通过减少免疫细胞向中枢神经系统的迁移，从而改善疾病症状。该研究为Laquinimod的分子机制提供了新的理解，为RRMS的治疗提供了新的思路。药物发现/临床前 AAN 2014 2014-04-08 拉喹莫德复发-缓解型多发性硬化 Sheba Medical Center | Teva Italia Srl Laquinimod Reduces Neuronal Injury Through Inhibiting Microglial Activation (I7-1.009) 该研究旨在探究拉奎尼莫德减少脑萎缩和多发性硬化（MS）患者残疾进展的机制。研究发现，拉奎尼莫德能够抑制微胶质细胞的活化，从而减少神经元损伤。实验结果显示，拉奎尼莫德能够降低微胶质细胞诱导的炎症因子分泌，减少神经细胞死亡，并在实验性自身免疫性脑脊髓炎（EAE）模型中减少轴突损伤和丧失。因此，拉奎尼莫德被证实为一种新型微胶质细胞活化抑制剂，对MS患者的治疗具有潜在的益处。 3期临床研究 AAN 2014 2014-04-08 拉喹莫德多发性硬化症 University of Calgary Calgary AB Canada Laquinimod Reduces Neuronal Injury Through Inhibiting Microglial Activation (P1.193) 本研究旨在探究拉奎尼莫德减少脑萎缩和多发性硬化（MS）两期三试验中观察到的残疾进展的机制。研究发现，拉奎尼莫德能够抑制人类微胶质细胞的活化，降低炎症分子水平，并减少微胶质细胞诱导的神经细胞死亡。在实验性自身免疫性脑脊髓炎（EAE）小鼠模型中，拉奎尼莫德能够减少微胶质细胞/巨噬细胞密度和轴突损伤，甚至在疾病进展时期停止进行性轴突丢失。此外，拉奎尼莫德还能降低EAE小鼠中诱导型一氧化氮合酶的水平，减少自由基毒性，并防止神经毒性。总之，拉奎尼莫德是一种新型微胶质细胞活化抑制剂，能够降低微胶质细胞诱导的促炎细胞因子分泌，减少神经细胞死亡，并减轻EAE中的轴突损伤和丢失。 3期临床研究 AAN 2014 2014-04-08 拉喹莫德多发性硬化症 University of Calgary | Teva Pharmaceutical Laquinimod Prevents NMOIg-Induced Disease Exacerbation in a Model of Neuromyelitis Optica. (P4.003) 本研究旨在探讨Laquinimod在神经脊髓炎免疫球蛋白(NMOIg)诱导的疾病恶化模型中的预防作用。研究发现，Laquinimod能够限制NMOIg进入中枢神经系统并减轻神经病理学和神经功能缺陷。实验结果显示，Laquinimod治疗能够阻止NMOIg引起的疾病恶化，减轻血脑屏障破坏，并调节星形胶质细胞产生的炎症因子，如VEGF-A。因此，Laquinimod可能成为NMO患者的联合治疗选择，限制自身抗体进入中枢神经系统，从而减轻神经病理学和神经功能缺陷。 3期临床研究 AAN 2014 2014-04-08 拉喹莫德视神经脊髓炎 Teva Italia Srl | Mount Sinai School of Medicine Safety and Tolerability of Escalating Doses of Laquinimod, an Oral Immunomodulatory Agent in Development for Treatment of Relapsing-Remitting Multiple Sclerosis (P2.205) 本研究旨在评估口服拉奎尼莫在多发性硬化症（RRMS）患者中的安全性和耐受性。研究结果表明，口服拉奎尼莫剂量逐渐增加至2.7mg对RRMS患者安全，并未发现剂量相关的安全信号。研究支持：Teva制药。 1期临床研究 AAN 2014 2014-04-08 拉喹莫德复发-缓解型多发性硬化 NeuroCure Clinical Research Center and Clinical and Experimental Multiple Sclerosis Research Center Berlin Germany | Universitatsklinik Ulm RKU Ulm Germany | Teva Pharmaceuticals Netanya Israel Pharmacokinetics of Laquinimod, an Oral Immunomodulatory Agent in Development for The Treatment of Relapsing-Remitting Multiple Sclerosis (P7.237) 该研究旨在对口服免疫调节剂拉奎尼莫在多发性硬化症治疗中的药代动力学进行表征。研究结果显示，拉奎尼莫在0.9-2.7mg剂量范围内的药代动力学呈线性关系，且在口服后迅速吸收，消除缓慢，连续每日给药两周后可达稳态。该研究由Teva Pharmaceuticals支持。药物发现/临床前 AAN 2014 2014-04-08 拉喹莫德复发-缓解型多发性硬化 NeuroCure | Teva Pharmaceutical Industries Ltd. | Universitatsklinik Ulm RKU Ulm A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Laquinimod 0.6mg or 1.2mg QD versus IFNβ-1a in Patients with Relapsing Remitting Multiple Sclerosis (P3.153) 本研究旨在评估口服拉奎尼莫0.6mg或1.2mg每日一次与肌内注射干扰素β-1a（IFNβ-1a IM）在缓解-复发型多发性硬化症（RRMS）患者中的疗效、安全性和耐受性。研究设计为多中心、随机、双盲、平行对照。研究将纳入18-55岁、RRMS患者，随机分配口服拉奎尼莫0.6mg（n=250）或1.2mg（n=250），或IM IFNβ-1a 30µg每周一次（n=100）治疗12个月。主要终点为MRI检查显示的脑体积变化百分比。预计研究结果将为拉奎尼莫在减少脑体积损失和新T2病变方面的疗效提供指导。 3期临床研究 AAN 2014 2014-04-08 拉喹莫德复发-缓解型多发性硬化 Università degli Studi di Genova Genoa Italy | Teva Pharmaceutical Industries Natanya Israel | Heinrich-Heine University Duesseldorf Düsseldorf Germany Laquinimod Regulates Inflammatory Gene Induction In A Human Model Of Reactive Astrogliosis. (P1.202) - 药物发现/临床前 AAN 2014 2014-04-08 拉喹莫德复发-缓解型多发性硬化 Teva Italia Srl | Mount Sinai School of Medicine Laquinimod Interferes With The Development Of Follicular Helper T Cells And Germinal Center B Cells In CNS Autoimmunity (P1.195) - 药物发现/临床前 AAN 2014 2014-04-08 拉喹莫德自身免疫性疾病 | 复发-缓解型多发性硬化 Neurology UCSF San Francisco CA United States | UCSF San Francisco CA United States P386 Pharmacokinetics of laquinimod in patients with active moderate to severe Crohn's disease 该研究评估了在活动性中重度克罗恩病患者中多剂量拉奎尼莫的药代动力学。结果显示，拉奎尼莫在1小时内达到最大浓度，并在24小时内保持稳态。药代动力学呈剂量线性，0.5至2.0毫克剂量范围内的系统曝光与剂量成比例。拉奎尼莫的药代动力学在克罗恩病患者中呈线性，并与健康志愿者和多发性硬化症患者相似。然而，药代动力学并不能解释为什么较低剂量的拉奎尼莫可以改善克罗恩病患者的临床症状，而较高剂量则无效。 2期临床研究 ECCO 2014 2014-02-01 拉喹莫德克罗恩病 Teva Branded Pharmaceutical Products R&D LLC DOP059 Reduction of fecal calprotectin levels and relationship to clinical parameters in the phase 2 study of laquinimod for the treatment of active moderate to severe Crohn's disease 该研究是一项关于拉奎尼莫治疗活动性中重度克罗恩病的二期研究。研究发现，0.5毫克和1.0毫克的拉奎尼莫剂量安全地诱导了患有活动性中重度克罗恩病的患者临床缓解。研究还探讨了拉奎尼莫是否能够降低患者的粪便卡尔保护蛋白浓度，这是一种肠道炎症的客观指标。研究结果显示，0.5毫克和1.0毫克的拉奎尼莫剂量增加了临床缓解和临床反应的患者比例，并且降低了粪便卡尔保护蛋白水平。因此，该研究表明，低剂量的拉奎尼莫在改善克罗恩病患者临床症状方面具有最强大和一致的效果。 2期临床研究 ECCO 2014 2014-02-01 拉喹莫德克罗恩病 Teva Branded Pharmaceutical Products R&D LLC Bayesian analysis of laquinimod’s effect on relapses and disability. 在Bayesian分析中使用拉昆莫对复发和残疾的影响。使用贝叶斯方法推测拉昆莫治疗复发的效果，并显示60%的可能性至少能减少30%的复发，并对减少残疾进展有更大的影响。拉昆莫对复发的平均减少率为21.3%，且几乎没有可能出现疾病恶化。对残疾进展分析显示，在拉昆莫治疗下存在60%的几率至少降低30%的残疾进展风险，90%的机会至少降低20%的残疾可能性。对残疾的影响在15.5%至45.5%之间。相关研究结果表明拉昆莫可以显著减少复发和残疾的风险。药物发现/临床前 ECTRIMS 2013 2013-09-30 拉喹莫德多发性硬化症 Teva Pharmaceuticals Netanya, IL | Teva Pharmaceuticals Petah Tikva, IL | University of Alabama - Birmingham School of Public Health Birmingham, US Preventive laquinimod treatment reduces cuprizone-induced pathology in wild type and TLR4-deficient mice. 本研究旨在测试Toll样受体4 (TLR4)信号在Laquinimod（LAQ）介导的对氧化铜诱导的脱髓鞘、炎症、轴突损伤和星形胶质增生的影响。结果显示LAQ对氧化铜模型的预防效果，星形胶质细胞在该模型和多发性硬化中的脱髓鞘中起关键作用，并且LAQ对星形胶质细胞的影响可能不涉及TLR4信号传导。此外，研究结果暗示LAQ可能在未来的多发性硬化治疗中发挥作用。Laquinimod是一种口服小分子药物，已被证明能减少多发性硬化患者的脑萎缩、残疾进展和复发率。最近的实验数据表明，LAQ能够减少氧化铜诱导的脱髓鞘和轴突损伤，主要通过下调星形胶质细胞NFkB活化来介导，独立于外周免疫细胞。研究结果显示，LAQ预防性治疗能减少氧化铜诱导的脱髓鞘、轴突损伤和星形胶质增生。药物发现/临床前 ECTRIMS 2013 2013-09-30 拉喹莫德多发性硬化症 Teva Pharmaceutical Industries Ltd. | University Medical Center Göttingen Laquinimod prevents NMOIg-induced disease exacerbation in a model of neuromyelitis optica. 本研究发现，Laquinimod能够成功限制NMOIg进入中枢神经系统并防止神经病理和神经功能缺陷的恶化。这项研究为NMO治疗提供了新的思路，Laquinimod可能作为联合治疗药物，限制神经病理和神经功能缺陷。这一发现为NMO患者带来了希望。药物发现/临床前 ECTRIMS 2013 2013-09-30 拉喹莫德视神经脊髓炎 The Johns Hopkins Hospital, Inc. | The Hospital Co. (Oxford John Radcliffe) Ltd. | Teva Pharmaceutical Industries Ltd. | Icahn School of Medicine at Mount Sinai Disease progression in relapse-free patients treated with laquinimod. 拉奎尼莫治疗无复发患者的疾病进展。拉奎尼莫观察到的临床益处表明其具有独特的疗效特点，对复发率有显著影响，对残疾进展有更大影响。拉奎尼莫对减少残疾和复发率的效果难以分离。拉奎尼莫对炎症和炎症外更广泛的潜在机制均有影响。拉奎尼莫相对安慰剂减少了残疾进展，对有复发患者的治疗效果为26.7％（P = 0.058），对无复发患者的治疗效果为38.9％（P = 0.036）。 3期临床研究 ECTRIMS 2013 2013-09-30 拉喹莫德疾病进展 - Laquinimod induces a shift in natural killer cell populations in mice with experimental autoimmune encephalomyelitis. 研究结果表明，拉奎尼莫处理能够在小鼠实验性自身免疫性脑脊髓炎（EAE）中诱导自然杀伤细胞（NK细胞）亚群向CD27+转变，并增加能抑制自反应T细胞增殖的MAC-1- NK细胞。这些拉奎尼莫介导的NK细胞功能影响可能有助于EAE的预防效果，同时在多发性硬化症（MS）患者中也可能发挥关键作用。拉奎尼莫同时可降低小鼠脾脏总核细胞和NK细胞数量，但不改变NK细胞频率。在体外实验中，拉奎尼莫处理导致的NK细胞亚群变化与其细胞杀伤能力和对特定T细胞抑制效果相关。这些发现为拉奎尼莫的免疫调节作用提供了进一步理解，也为在生物医药领域中的多发性硬化症治疗研究提供了重要依据。药物发现/临床前 ECTRIMS 2013 2013-09-30 拉喹莫德脑脊髓炎 Teva Pharmaceutical Industries Ltd. | University Medical Center Göttingen Multicentre, randomized, placebo controlled study to evaluate the efficacy, safety and tolerability of two doses of oral laquinimod (0. 本研究是一项多中心、随机、安慰剂对照的研究，旨在评估口服拉奎尼莫两种剂量（0.6mg和1.2mg）的疗效、安全性和耐受性。研究对象为多发性硬化症（RRMS）患者，共有1800名患者参与。研究的主要终点是确认疾病进展的时间（CDP），次要终点包括大脑体积变化、首次确认的复发时间等。研究已于2013年2月开始招募，最后一名患者于2015年2月入组。拉奎尼莫在两项3期试验中显示出临床益处，表明其具有较强的疗效和较大的残疾进展抑制效果。CONCERTO试验旨在提供额外的数据，以证实0.6mg/天剂量的拉奎尼莫对RRMS患者的治疗效果，并探讨1.2mg/天剂量是否具有更大的疗效，同时保持足够的安全性和耐受性。 3期临床研究 ECTRIMS 2013 2013-09-30 拉喹莫德复发-缓解型多发性硬化 T. Vollmer 1, X. Montalban 2, G. Comi 3, T. Ziemssen 4, A. Boyko 5, P. Vermersch 6, N. Sasson 7, T. Gorfine 7, V. Knappertz 8, M. Filippi 9 Laquinimod regulates inflammatory gene induction in a human model of reactive astrogliosis. Laquinimod是一种口服免疫调节剂，对先天免疫系统具有作用，并目前正在进行缓解-复发型多发性硬化（RRMS）的III期临床试验。Laquinimod能够穿过血脑屏障，进入中枢神经系统，除了在外周的作用外，也可能直接影响包括星形胶质细胞和微胶质细胞在内的中枢神经系统免疫相关细胞系，这些细胞系越来越多的证据显示是中枢神经系统炎症和修复的关键调节者。研究发现，Laquinimod对原代人体反应性星形胶质增生的细胞模型中的前炎症基因表达产生深远影响。在治疗浓度下，Laquinimod能有剂量依赖性地抑制IL-1β诱导的细胞因子和其他炎症介质的产生。这些效应表明Laquinimod可能通过对免疫能力中枢神经系统细胞的直接作用，限制病变的发生，在RRMS和其他炎症性中枢神经系统疾病中发挥作用。 3期临床研究 ECTRIMS 2013 2013-09-30 拉喹莫德 - Teva Pharmaceutical Industries Ltd. | Mount Sinai School of Medicine Evaluating the relationship between laquinimod’s effects on relapse and disability progression. 该研究使用Sormani等人在神经学杂志2010年发表的方程式，评估了拉奎尼莫对多发性硬化复发和残疾进展的影响。结果显示，拉奎尼莫对减少残疾进展的效果大于对减少复发率的效果。研究人员收到了来自多家公司的咨询和演讲费。研究方法包括使用已发表的回归方程，将拉奎尼莫对复发率的观察效果代入方程，评估其对残疾进展的预测值。研究结果显示，拉奎尼莫对残疾进展的观察效果与预测值存在明显差异，表明其对复发和残疾的影响存在显著分离。 3期临床研究 ECTRIMS 2013 2013-09-30 拉喹莫德 - Teva Pharmaceutical Industries Ltd. | The University of Colorado | University of Genoa Predicting brain volume loss at two years as a function of MRI activity in the first year with laquinimod. 生物医药领域教授总结如下：Laquinimod是一种口服药物，已证实能显著减少多发性硬化患者大脑体积的损失。研究发现，Laquinimod治疗第一年的GM和丘脑体积变化，以及新T1病变的累积数量，可以预测大脑体积损失。研究结果显示，GM和丘脑体积的变化与24个月内的大脑体积变化呈正相关，而基线T2病变体积与24个月内的大脑体积变化呈负相关。同时，第一年内新T1病变的累积数量也与12个月到24个月的大脑体积变化呈负相关。这些发现有助于预测Laquinimod治疗对大脑体积的影响。 3期临床研究 ECTRIMS 2013 2013-09-30 拉喹莫德 - Cornerstone Dental Care | Teva Pharmaceutical Industries Ltd. | University “Vita - Salute” Milan Mechanisms of laquinimod in multiple sclerosis: focus on microglia. - 药物发现/临床前 ECTRIMS 2013 2013-09-30 拉喹莫德多发性硬化症 University of Calgary The risk of disability progression is associated with multiple sclerosis functional composite (MSFC) scores in the laquinimod phase 3 trials. 多发性硬化功能组合（MSFC）得分与拉奎尼莫德第3期试验中的残疾进展风险相关。拉奎尼莫德是一种口服免疫调节剂，用于治疗多发性硬化的复发型，它在第3期试验中一致减少了脑体积损失百分比，并减缓了残疾进展，但与安慰剂相比，它并未显著改善整体MSFC z-分数。研究结果表明，MSFC的变化与残疾进展风险相关，拉奎尼莫德治疗组的进展速度最快，而与安慰剂组相比，这种关联更为显著。拉奎尼莫德组的风险最低，几乎是安慰剂患者的一半。总体MSFC z-分数与月份12和月份24的EDSS个体分数呈负相关关系。 3期临床研究 ECTRIMS 2013 2013-09-30 拉喹莫德多发性硬化症 Teva Pharmaceuticals Netanya, IL | Copenhagen University Hospital Copenhagen, DK | Teva Pharmaceuticals Petah Tikva, IL Laquinimod interferes with the development of follicular helper T cells and germinal center B cells in CNS autoimmunity. Laquinimod是一种新型口服免疫调节药物，用于治疗复发-缓解型多发性硬化（MS）和其他自身免疫疾病。研究表明，Laquinimod干预了中枢神经系统自身免疫中滤泡辅助T细胞和生发中心B细胞的发育。实验结果显示，Laquinimod治疗能够干扰Tfh细胞的生成，减少生发中心B细胞的成熟和抗-MOG IgG的产生，表明其可能有益于体液免疫性疾病。研究还发现，Laquinimod通过影响抗原呈递细胞（APC）来调节Tfh细胞的命运，而不是直接作用于T细胞。这些发现为Laquinimod在自身免疫疾病治疗中的潜在作用提供了新的证据。药物发现/临床前 ECTRIMS 2013 2013-09-30 拉喹莫德复发-缓解型多发性硬化 UCSF San Francisco, US A RANDOMIZED CONTROLLED STUDY OF LAQUINIMOD IN ACTIVE LUPUS NEPHRITIS PATIENTS IN COMBINATION WITH STANDARD OF CARE 本研究旨在评估拉奎尼莫（LAQ）与标准治疗（SoC）联合治疗对活动性狼疮肾炎（LN）患者的安全性、耐受性和临床效果。研究结果显示，与安慰剂相比，LAQ组的eGFR和蛋白尿水平改善更显著。LAQ组的肾功能改善率分别为0.5mg组为62.5%，1mg组为40%，安慰剂组为33.3%。在治疗期间，各组常见不良事件（AEs）发生率无显著差异，且LAQ剂量均耐受良好。虽然结果令人鼓舞，但这个小型IIa期试验并未有足够的统计学力量来明确区分各治疗组之间的差异。未来将进行更大规模的研究以确认本研究观察到的安全性和疗效。 2期临床研究 EULAR 2013 2013-06-12 拉喹莫德狼疮性肾炎 - Laquinimod suppression of lupus nephritis in BWF1 mice associates in renal tissue with increase of myeloid suppressor cells and switch of macrophages to anti-inflammatory type II (P5193) - 药物发现/临床前 AAI 2013 2013-05-01 拉喹莫德狼疮性肾炎 1 Medicine, UCLA, Los Angeles, CA Laquinimod Treatment Reverses Cortical and Hippocampus Pathology Due to Inflammatory Demyelination in a Chronic Mouse Model of Multiple Sclerosis (P06.126) 本研究旨在评估Laquinimod治疗对EAE大鼠的皮层和海马病理的影响。结果显示，Laquinimod治疗显著改善了EAE大鼠的临床疾病评分，减少了皮层和海马的病变数量、脱髓鞘、神经退行性变化和微胶质细胞活化。此外，Laquinimod治疗还增加了突触小体数量，改善了神经树突完整性，并显著减少了皮层和海马中的凋亡细胞数量。这些结果支持了Laquinimod在治疗EAE和可能的MS相关皮层和海马病理中的作用。药物发现/临床前 AAN 2013 2013-02-12 拉喹莫德多发性硬化症 Neurology UCLA School of Medicine Los Angeles CA Therapeutic Laquinimod Treatment Restores Axon Myelination, Callosal Conduction and Motor Deficit in a Chronic Mouse Model of Multiple Sclerosis (P05.197) 该研究证实，治疗性的拉奎尼莫德对多发性硬化慢性小鼠模型具有益处，能够恢复轴突髓鞘化、脑连合传导和运动功能缺陷。拉奎尼莫德治疗显著改善了实验性自身免疫性脑脊髓炎(EAE)疾病评分和Rotorod运动表现，减少了炎症因子和脑部活化细胞数量，增加了髓鞘化轴突和成熟寡突胶质细胞数量。这些结果进一步支持了拉奎尼莫德在治疗多发性硬化症中的潜在作用。药物发现/临床前 AAN 2013 2013-02-12 拉喹莫德多发性硬化症 Neurology UCLA School of MEdicine Los Angeles CA Comparison of Early and Delayed Oral Laquinimod in Patients with Relapsing-Remitting Multiple Sclerosis: Effects on Disability Progression at 36 Months in the ALLEGRO Trial (S41.004) 本研究比较了早期和延迟口服拉奎尼莫在复发缓解型多发性硬化患者中的效果。结果显示，在36个月的研究中，早期开始治疗的患者与延迟开始治疗的患者相比，残疾进展的风险显著降低。在接受拉奎尼莫治疗的患者中，没有出现新的安全问题。这项研究得到了 Teva Pharmaceuticals 的支持。 3期临床研究 AAN 2013 2013-02-12 拉喹莫德复发-缓解型多发性硬化 - Laquinimod Induces a Shift from Pro-inflammatory to Regulatory T Cells and Decreases Myeloid Dendritic Cells in Mice with Experimental Autoimmune Encephalomyelitis (P05.149) 新药拉奎尼莫（LAQ）在小鼠实验性自身免疫脑脊髓炎（EAE）模型中，能够通过减少炎症性T细胞、增加调节性T细胞，以及降低髓样树突状细胞的数量，从而抑制自身免疫反应。这些发现表明，LAQ可能在未来的多发性硬化治疗中发挥作用。药物发现/临床前 AAN 2013 2013-02-12 拉喹莫德脑脊髓炎 Department of Neuropathology Goettingen Germany P379 Safety and efficacy of laquinimod in inducing clinical and biochemical improvement in active Crohn's disease: Results of an exploratory trial 该研究评估了拉奎尼莫在活动性中重度克罗恩病患者中的安全性和有效性，并评估了该药物对粪便卡尔保护蛋白的影响作为肠道炎症的客观生物标志物。结果显示，拉奎尼莫治疗良好耐受，0.5和1毫克剂量可能对缓解和反应产生临床相关效果。所有剂量（0.5-2毫克）均降低了活动性克罗恩病的肠道炎症的客观指标。 2期临床研究 ECCO 2013 2013-02-01 拉喹莫德克罗恩病 - Laquinimod Treatment Reduces an Immunogenic Dendritic Cell Population and Protects from Autoimmune CNS Inflammation (P02.117) 该研究发现，利凯尼莫治疗能够减少免疫原性树突状细胞的数量，从而保护机体免受自身免疫性中枢神经系统炎症的侵害。利凯尼莫在临床试验中显示出0.6mg对缓解多发性硬化症患者病情活动具有益处，能够减缓残疾的进展、降低脑容积损失速率和复发率，并且具有良好的安全性和耐受性。研究结果表明，利凯尼莫可能通过调节树突状细胞和T细胞反应来发挥其抑制疾病的作用。该研究得到以色列特瓦制药工业公司的无限制赞助。 3期临床研究 AAN 2012 2012-04-23 拉喹莫德炎症 Institute for Molecular Medicine Mainz Germany Laquinimod Add on Effect on Glatiramer Acetate as Well as INFb Treatments (P04.142) Laquinimod是一种口服中枢神经系统活性免疫调节剂，对多发性硬化症（MS）患者的疾病进展和脑组织损失有明显影响。Laquinimod在实验性自身免疫脑脊髓炎（EAE）动物模型中显示出显著的疾病严重程度减轻作用。Laquinimod可能通过NFkB信号抑制发挥作用，影响星形胶质细胞和微胶质细胞，减少促炎细胞因子。Glatiramer acetate（GA）和IFNb是常用于RRMS治疗的药物，与Laquinimod联合治疗在EAE模型中显示出更好的疗效。这些结果表明联合使用这些药物可能成为RRMS患者的潜在治疗方案。 3期临床研究 AAN 2012 2012-04-23 拉喹莫德 RRMS Teva Italia Srl Treatment with Oral Laquinimod Augments the In Situ Expression of Brain-Derived Neurotrophic Factor and Reduces CNS Injury (P02.106) - 药物发现/临床前 AAN 2012 2012-04-23 拉喹莫德多发性硬化症 The Weizmann Institiute of Science Rehovot Israel Clinical Efficacy of Laquinimod for the Treatment of Multiple Sclerosis; Pooled Analyses from the ALLEGRO and BRAVO Phase III Trials (S01.007) Laquinimod对多发性硬化的临床疗效：ALLEGRO和BRAVO三期试验的汇总分析（S01.007）。背景：Laquinimod是一种口服的中枢神经系统免疫调节剂，用于治疗多发性硬化。其对残疾进展和脑萎缩的影响是多发性硬化患者长期结果的两个指标，在其三期试验中正在研究。结论：Laquinimod减缓了残疾进展和脑萎缩，安全性良好，表明它可能在改善多发性硬化患者的长期结果中发挥重要作用。支持者：以色列Teva制药公司。设计：多发性硬化患者（N=2437）被随机分配到laquinimod组（n=984）或安慰剂组（n=1006）。在两项试验中，患者在筛选、基线访视和每3个月直到停药或24个月结束时接受神经学检查，包括扩展的残疾状态量表（EDSS）。MRI扫描在筛选、基线、第12个月和第24个月访视时进行。年复发率是主要终点，3个月确认的残疾进展风险是次要终点。使用SIENA技术的脑容积百分比变化是ALLEGRO试验的探索性终点，BRAVO试验的次要终点。目的：本报告提供了对最近完成的ALLEGRO和BRAVO三期试验中laquinimod对复发、残疾和脑萎缩指标的汇总分析的详细信息。结果：年复发率的汇总分析发现，laquinimod将复发率降低了21.4%（laquinimod患者的年复发率为0.30，安慰剂患者为0.38，p=0.0005）。对3个月确认的残疾进展风险的汇总分析发现，laquinimod显著降低了风险，降低了34.2%（p=0.0017）。使用更严格的标准，即持续6个月的残疾，laquinimod显著减少了46%（p<0.0001）。脑容积百分比变化减少了30%（laquinimod患者为-0.835%，安慰剂患者为-1.188%，p<0.001）。 3期临床研究 AAN 2012 2012-04-23 拉喹莫德多发性硬化症 Cornerstone Coordinated Health Care LLC Pooled Analyses from the ALLEGRO and BRAVO Trials on the Safety and Tolerability of Laquinimod as a Multiple Sclerosis Treatment (P04.132) 两项临床试验ALLEGRO和BRAVO的综合分析显示，拉奎尼莫作为一种口服免疫调节剂，能够减少多发性硬化（MS）患者的疾病负担，减缓残疾进展，减少脑萎缩，并通过减少复发和MRI活性影响疾病活动。安全数据支持了拉奎尼莫在早期II期研究中建立的安全性和耐受性。结合疗效数据，拉奎尼莫有潜力成为一种安全的口服药物治疗多发性硬化。在综合分析中，拉奎尼莫组和安慰剂组患者报告的不良事件（AE）分别为81.8%和76.2%，常见的AE包括头痛、背痛、关节痛、肝酶增高、尿路感染、咳嗽和腹痛。拉奎尼莫组和安慰剂组的严重不良事件（SAEs）分别为9%和6.4%，早期终止由于不良事件的患者分别为6.4%和4.7%。主要的早期终止原因是胃肠道和腹痛。 3期临床研究 AAN 2012 2012-04-23 拉喹莫德多发性硬化症 Cornerstone Coordinated Health Care LLC Laquinimod Treatment Enhances Callosal Conduction in a Chronic Mouse Model of Multiple Sclerosis (P02.070) 该研究发现，低至5mg/kg/day剂量的拉奎尼莫在EAE模型中有显著的益处，能改善由于对寡突胶质细胞数量和髓鞘密度的积极影响而改进的轴突传导。这些结果进一步支持了拉奎尼莫在治疗多发性硬化症中的潜在作用。拉奎尼莫治疗显著降低了Th1细胞因子、Th2细胞因子和MMP9的水平，减少了大脑中的反应性星形胶质细胞、活化小胶质细胞和T细胞。此外，在脊髓和大脑中，拉奎尼莫治疗组的髓鞘密度、寡突胶质细胞和轴突数量均有所增加。拉奎尼莫治疗在疾病前后显著改善了髓帶传导，使轴突的不应期恢复到接近正常水平，这些结果为拉奎尼莫在多发性硬化症治疗中的潜在作用提供了进一步的支持。 3期临床研究 AAN 2012 2012-04-23 拉喹莫德多发性硬化症 Neurology UCLA School of Medicine Los Angeles CA Laquinimod Protects from Cuprizone-Induced Demyelination through Modulation of Astrocyte Activation Via Interfering with the NFκ-B Pathway (S31.002) 本研究证实了拉奎尼莫对杯螯状铜诱导的脱髓鞘具有保护作用，通过干预NFκ-B途径从而调节星形胶质细胞的活化。拉奎尼莫已在临床试验中证实对多发性硬化症（MS）具有显著疗效，主要作用是减少大脑萎缩和残疾进展。本研究结果表明，拉奎尼莫通过调节中枢神经系统内的炎症反应，保护了髓鞘、寡突胶质细胞和轴突。这一发现为探索治疗MS的新途径提供了重要参考。 3期临床研究 AAN 2012 2012-04-23 拉喹莫德 - Teva Pharmaceuticals Netanya Israel | Department of Neuropathology University Medical Center Göttingen Germany Analysis of Laquinimod Efficiency during Experimental Autoimmune Encephalomyelitis (P02.115) Laquinimod是一种口服的中枢神经系统免疫调节剂，已在多发性硬化患者中显示出积极效果。在实验性自身免疫脑脊髓炎（EAE）模型中，Laquinimod能够通过减少促炎性Th1细胞的细胞因子产生来发挥作用。研究结果显示，Laquinimod在预防和治疗EAE方面均表现出剂量依赖性的改善作用，能够减少MOG特异性T细胞的增殖，并降低促炎细胞因子的产生。这些发现有助于深入了解Laquinimod在EAE中的细胞作用机制。药物发现/临床前 AAN 2012 2012-04-23 拉喹莫德脑脊髓炎 Department of Neuroimmunology, Institute for Multiple Sclerosis Research, University of Göttingen Göttingen Germany Effects of Laquinimod on the Human Blood-Brain Barrier (P02.118) 该研究旨在评估拉奎尼莫在人类血脑屏障上的作用。研究结果表明，拉奎尼莫能够增强血脑屏障内皮细胞的紧密连接，减少炎症介质的分泌，并限制免疫细胞向中枢神经系统的迁移。这些发现为拉奎尼莫在治疗多发性硬化症中的作用机制提供了新的证据，也为其临床应用提供了理论支持。药物发现/临床前 AAN 2012 2012-04-23 拉喹莫德多发性硬化症 CHUM-Notre-Dame Hospital Laquinimod Promotes T Cell Immune Modulation in Central Nervous System Autoimmunity Via Type II (M2) Myeloid APC (P02.105) Laquinimod通过M2型髓样抗原呈递细胞促进中枢神经系统自身免疫调节（P02.105）。Laquinimod是一种新型口服药物，正在评估其治疗复发缓解型多发性硬化（MS）的效果。在MS模型EAE中，Laquinimod已被证明能减少中枢神经系统的浸润和脱髓鞘，同时促进T细胞免疫调节。我们的研究结果表明，Laquinimod并不直接作用于T细胞，而是通过对髓样抗原呈递细胞的影响来调节适应性T细胞免疫应答。Laquinimod的口服治疗逆转了已建立的RR-EAE，并伴随着减少中枢神经系统炎症、减少Th1和Th17反应以及增加调节性T细胞（Treg）。在体内Laquinimod治疗改变了髓样抗原呈递细胞的亚群，包括减少CD11c+CD11b+CD4+树突状细胞和增加CD11bhiGr1hi单核细胞。这些CD11b+细胞表现出抗炎的M2型表型，特征是减少STAT1磷酸化、减少IL-6、IL-12/23和TNF的产生，以及增加IL-10。在移植转移中，这些供体M2型单核细胞抑制了已建立EAE的受体的临床和组织学表现。我们的研究结果表明，Laquinimod对T细胞免疫调节的作用是通过改变髓样抗原呈递细胞的功能而不是直接作用于T细胞。药物发现/临床前 AAN 2012 2012-04-23 拉喹莫德 Central Nervous System Autoimmunity University of California | Neurology San Francisco Laquinimod Restricts Inflammatory Gene Expression in a Human Model of Reactive Astrogliosis (P02.111) Laquinimod是一种口服的中枢神经系统活性免疫调节剂，目前正在进行缓解-复发型多发性硬化症（RRMS）的III期临床试验。研究发现，Laquinimod在人体反应性星形胶质增生的模型中显著影响促炎基因的表达。在治疗浓度下，Laquinimod能够抑制IL-1β诱导的细胞因子，包括肿瘤坏死因子-α（TNFα）和IL-6，以及诱导型一氧化氮合酶。此外，Laquinimod还不同程度地调节IL-1β诱导的CXC和CC趋化因子的表达，表明其在星形胶质细胞培养中作为免疫调节剂而非免疫抑制剂。研究结果揭示了Laquinimod作为反应性星形胶质增生的调节剂，可能通过中枢神经系统细胞限制多发性硬化症病变的发展。 3期临床研究 AAN 2012 2012-04-23 拉喹莫德复发-缓解型多发性硬化 Mount Sinai School of Medicine | Teva Pharmaceuticals Netanya Israel Prolonged Incubation with Laquinimod Protects Hippocampal Cells from Oxidative Stress (P02.110) Laquinimod是一种口服的中枢神经系统活性免疫调节剂，已在多发性硬化（MS）患者中显示出有益效果。研究发现，Laquinimod能够保护海马HT22细胞免受氧化应激的损害，这种保护需要七天的时间才能发挥作用。结果表明Laquinimod可能通过改变基因转录来发挥作用，而不是通过NRF2介导的途径。此外，Laquinimod对谷氨酸半胱氨酸连接酶和xCT的转录活化也产生了相关影响。这些发现为Laquinimod作为一种新型口服治疗MS的药物具有抗氧化潜力提供了证据。 3期临床研究 AAN 2012 2012-04-23 拉喹莫德 - Neurology University Hospital Duesseldorf Duesseldorf Germany Placebo-Controlled Trial of Oral Laquinimod for Multiple Sclerosis 本研究是一项关于口服拉奎尼莫治疗多发性硬化症的安慰剂对照试验。研究结果显示，与安慰剂相比，口服拉奎尼莫能显著降低多发性硬化症患者的年复发率，减少残疾进展的风险，并降低磁共振成像中的病变数量。研究还发现，部分患者在服用拉奎尼莫后会出现临时的丙氨酸氨基转移酶水平升高。总之，这项研究表明口服拉奎尼莫能有效减缓多发性硬化症患者的残疾进展速度和复发率。 3期临床研究 Pubmed 2012-03-15 拉喹莫德复发-缓解型多发性硬化 Institute of Neurology | Department of Neurology and Institute of Experimental Neurology, Università Vita-Salute San Raffaele Mechanisms of laquinimod in reducing the accumulation of monocytoid cells in the CNS Laquinimod通过减少中枢神经系统中单核细胞的积聚来发挥作用。研究发现，Laquinimod能够减弱培养中的人单核细胞和微胶质细胞的活性。在小鼠EAE疾病模型中，Laquinimod能够显著减少激活的巨噬细胞/微胶质细胞的存在，并阻止M1型促炎单核细胞进入脊髓。此外，Laquinimod还通过减少细胞因子、MMPs和整合素的作用，以及调节与应激相关的MAPK的磷酸化状态，来减少单核细胞在中枢神经系统中的积聚。这些作用有助于解释Laquinimod在多发性硬化症患者中的治疗益处。药物发现/临床前 SFN 2011 2011-11-13 拉喹莫德 MS Clin. Neurosci Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study 在多发性硬化患者中，口服每日0.6毫克拉奎酰胺显著减少了MRI测量的疾病活性，并且耐受性良好。这是一个多中心、随机、双盲、安慰剂对照的IIb期研究，共有51个中心在九个国家参与。研究结果显示，与安慰剂相比，每日0.6毫克拉奎酰胺可显著降低最后四次扫描中基线调整后的GdE病灶数量（简单平均数4.2 [SD 9.2] vs 2.6 [5.3]，p=0.0048）；每日0.3毫克的剂量则没有显著效果。拉奎酰胺的两个剂量均耐受良好，但一例布-克-恰里综合征在接受0.6毫克拉奎酰胺的患者出现，经抗凝治疗后已恢复。这一研究结果表明，在复发缓解型多发性硬化患者中，每日0.6毫克拉奎酰胺可显著降低MRI测量的疾病活性，并且耐受性良好。 2期临床研究 Pubmed 2008-06-01 拉喹莫德复发-缓解型多发性硬化 Sheffield Teaching Hospitals NHS Foundation Trust | University Vita‐Salute Synthesis and Biological Evaluation of New 1,2-Dihydro-4-hydroxy-2-oxo-3-quinolinecarboxamides for Treatment of Autoimmune Disorders: Structure−Activity Relationship 本研究合成并评估了新的1,2-二氢-4-羟基-2-酮基-3-喹啉羧酰胺类化合物，用于治疗自身免疫性疾病。通过小鼠急性实验性自身免疫性脑脊髓炎模型和狗的炎症反应实验，评估了这些化合物的抑制疾病发展的效果。研究讨论了结构活性关系，发现化合物8c（拉奎尼莫德）相较于前体化合物罗奎尼酮（1b，利诺酰胺）具有更高的效力和更优越的毒理学特性，目前已被选定用于临床研究（目前处于II期）。药物发现/临床前 J Med Chem 2004-03-16 拉喹莫德自身免疫性疾病 Active Biotech AB

2026-05-07

·activebiotech.com

Active Biotech Interim Report Q1 2026

EVENTS DURING THE FIRST QUARTER The US Patent Office (US PTO) granted a patent related to a pharmaceutical formulation of tasquinimod (January) Active Biotech receives positive feedback on its clinical study with tasquinimod in myelofibrosis (February 10) EVENTS AFTER THE END OF THE PERIOD Annual Report 2025 Active Biotech AB (publ) published (April 1) Preclinical data with tasquinimod in myelodysplastic neoplasms published in HemaSphere (April 14) Active Biotech publishes results from the LION study on ocular absorption and distribution of laquinimod in the eye (April 20) FINANCIAL SUMMARY The report is also available at www.activebiotech.com The information was submitted, through the agency of the contact person below, for public disclosure on 2026-05-07 at 08:30 CEST. Active Biotech AB (Corp.Reg.no. 556223-9227) / Scheelevägen 22, SE-223 63 Lund / +46 46 19 20 00

专利到期

2026-04-20

·activebiotech.com

Active Biotech publishes results from the LION study on ocular absorption and distribution of laquinimod in the eye

“I am tremendously satisfied and gratified to learn that topical laquinimod, even at a low dose, can penetrate into the anterior chamber and, more importantly, the vitreous of human eyes. The potential applications of a topical formulation and delivery that reaches the posterior segment are quite significant and can lead to very important and novel therapeutic implications. Our talented team at Byers and Stanford is very excited with the outcomes of the study,” said Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology, Medicine and Pediatrics at the Byers Eye Institute and the Stanford University School of Medicine (Palo Alto, USA) and Principal Investigator of the LION Study. The article, titled Safety and Biodistribution of Topical Laquinimod, an Immunomodulator Targeting Aryl Hydrocarbon Receptor: The LION Study, was published in Ophthalmology Science with Dr. Dalia El Feky, a Visiting Scholar at the Byers Eye Institute, Stanford University as well as an ophthalmologist and uveitis specialist in the Faculty of Medicine, Tanta University in Egypt, as the lead author. There is an unmet need for a topical, non-steroidal therapy with a favourable safety profile for patients with non-anterior non-infectious uveitis. Previously, several steroidal and non-steroidal topical agents have failed to reliably demonstrate absorption to the posterior segment of the eye. LION was designed to study the ocular biodistribution of the topical hydrogel formulation of laquinimod and to evaluate its therapeutic potential for ocular inflammatory diseases involving the posterior segment of the eye. The article is the result of a collaboration between Active Biotech, clinician-researchers at the Byers Eye Institute at Stanford University and the Global Ophthalmic Research Center (GORC). The results showed that daily doses of either 0.6, 1.2 or 1.8 mg of laquinimod in the topical formulation resulted in dose related intraocular concentrations of laquinimod in the posterior as well as the anterior parts of the eye. Topical laquinimod was well tolerated, and no dose-limiting toxicities were reported. Such findings support investigating laquinimod’s therapeutic potential for inflammatory eye diseases affecting the posterior segment. Active Biotech’s focus for the laquinimod program is now directed towards identifying the best development partner for the continued clinical development of laquinimod in eye disorders. Link to article: https://www.ophthalmologyscience.org/article/S2666-9145(26)00124-7/fulltext

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100 项与拉喹莫德相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D08938	拉喹莫德	N07XX10	DB06685

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适应症	国家/地区	公司	日期
多发性硬化症	俄罗斯	Active Biotech AB	2018-08-22

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适应症	最高研发状态	国家/地区	公司	日期
复发性多发性硬化	临床3期	美国	Teva Branded Pharmaceutical Products R&D LLC	2009-11-10
复发性多发性硬化	临床3期	奥地利	Teva Branded Pharmaceutical Products R&D LLC	2009-11-10
复发性多发性硬化	临床3期	保加利亚	Teva Branded Pharmaceutical Products R&D LLC	2009-11-10
复发性多发性硬化	临床3期	加拿大	Teva Branded Pharmaceutical Products R&D LLC	2009-11-10
复发性多发性硬化	临床3期	捷克	Teva Branded Pharmaceutical Products R&D LLC	2009-11-10
复发性多发性硬化	临床3期	爱沙尼亚	Teva Branded Pharmaceutical Products R&D LLC	2009-11-10
复发性多发性硬化	临床3期	法国	Teva Branded Pharmaceutical Products R&D LLC	2009-11-10
复发性多发性硬化	临床3期	德国	Teva Branded Pharmaceutical Products R&D LLC	2009-11-10
复发性多发性硬化	临床3期	匈牙利	Teva Branded Pharmaceutical Products R&D LLC	2009-11-10
复发性多发性硬化	临床3期	以色列	Teva Branded Pharmaceutical Products R&D LLC	2009-11-10

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适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06161415 (LION, Pubmed \| Ophthalmol Sci)	临床1期	眼部疾病	10	Laquinimod 0.6 mg	鏇壓構淵簾鏇顧鏇淵襯(餘夢選鏇觸觸構製鑰製) = Laquinimod was well tolerated at all doses, with 3 adverse events unrelated to the study drug 夢製襯壓鹹遞築範簾鬱 (繭鹽鑰築襯廠壓觸衊獵 )	积极	2026-06-01
				Laquinimod 1.2 mg
NCT01085084 (CTgov)	临床2期	系统性红斑狼疮	82	Placebo (Placebo)	簾窪襯鹹簾餘襯顧築糧 = 蓋糧衊網壓簾壓襯淵選齋窪襯繭鑰憲醖鑰艱鹹 (繭願鬱醖膚簾艱積選衊, 遞鏇膚網壓膚選獵窪觸 ~ 築簾衊齋觸選製製齋衊) 更多	-	2022-07-07
				Placebo+Laquinimod (Laquinimod 0.5 mg)	簾窪襯鹹簾餘襯顧築糧 = 窪繭製艱醖廠鬱遞醖艱齋窪襯繭鑰憲醖鑰艱鹹 (繭願鬱醖膚簾艱積選衊, 簾鏇糧艱餘願鹹選蓋簾 ~ 夢構齋顧壓築鹹製鬱壓) 更多
NCT00605215 (BRAVO, CTgov)	临床3期	复发-缓解型多发性硬化	1,331	Placebo (Placebo)	鹹廠築鏇獵齋選憲獵膚(衊顧襯獵窪製齋壓製鹽) = 糧膚鏇襯衊衊膚齋鬱夢製製淵願遞鹽襯積廠構 (鹽襯壓遞觸築齋繭襯膚, 範鏇廠廠鹽遞築築製觸 ~ 膚築窪蓋鹽願遞壓夢齋) 更多	-	2022-04-21
				Laquinimod (Laquinimod)	鹹廠築鏇獵齋選憲獵膚(衊顧襯獵窪製齋壓製鹽) = 衊壓艱鬱願獵選鹹顧鹹製製淵願遞鹽襯積廠構 (鹽襯壓遞觸築齋繭襯膚, 艱築廠獵襯網襯構糧鹽 ~ 範窪觸鹽鑰願顧範鹽艱) 更多
NCT01085097 (CTgov)	临床2期	狼疮性肾炎	46	Placebo+Methylprednisolone+Prednisone+Prednisolone+mycophenolate mofetil (Placebo)	築醖膚淵遞鬱鑰糧壓觸 = 築範簾鏇糧餘廠餘築願願積醖鹹鹹鹽窪範膚觸 (鏇築鹹夢範夢艱鹽繭遞, 鹹繭鬱築網齋夢蓋淵艱 ~ 衊顧願製窪願廠餘鬱觸) 更多	-	2022-03-09
				Placebo+Methylprednisolone+Prednisone+Prednisolone+mycophenolate mofetil+Laquinimod (Laquinimod 0.5 mg)	築醖膚淵遞鬱鑰糧壓觸 = 鏇鹽衊醖積觸築壓廠鏇願積醖鹹鹹鹽窪範膚觸 (鏇築鹹夢範夢艱鹽繭遞, 繭網鏇餘鹹繭鏇壓衊壓 ~ 範鹹衊鏇憲壓鑰構襯淵) 更多
NCT00509145 (ALLEGRO, CTgov)	临床3期	复发-缓解型多发性硬化	1,106	Laquinimod (Laquinimod)	鹹鹽窪願膚衊範繭顧糧(製鹽鹽膚窪醖憲積窪網) = 積衊淵齋繭觸範憲積鬱願繭憲鬱廠鹹觸窪鏇憲 (鑰衊選醖憲獵膚積壓製, 0.88) 更多	-	2021-11-02
				Placebo (Placebo)	鹹鹽窪願膚衊範繭顧糧(製鹽鹽膚窪醖憲積窪網) = 糧觸鬱鏇衊憲憲鑰淵願願繭憲鬱廠鹹觸窪鏇憲 (鑰衊選醖憲獵膚積壓製, 0.92) 更多
NCT01707992 (CONCERTO, Pubmed \| Mult Scler)	临床3期	复发-缓解型多发性硬化	2,199	Laquinimod 0.6 mg	艱衊窪繭齋範網選淵願(憲襯製餘鑰廠鑰鹹觸積) = 鬱繭構繭齋蓋窪齋醖觸鬱簾憲夢鏇膚窪膚遞襯 (襯顧襯獵襯壓獵襯鹽齋 )	不佳	2021-08-11
NCT02284568 (ARPEGGIO, Pubmed \| Neurology)	临床2期	原发性进行性多发性硬化	374	Laquinimod 0.6 mg	範構蓋鏇餘構餘艱膚憲(選鬱願構遞廠夢積選蓋): risk ratio = 0.4 (95% CI, 0.26 ~ 0.69), P-Value = 0.001 更多	不佳	2020-08-25
				Placebo
NCT02215616 (LEGATO-HD, MDS2019)	临床2期	亨廷顿舞蹈病	-	Laquinimod 1.0 mg	觸壓蓋鹹鑰築糧憲壓憲(憲願夢遞範築衊選衊鑰) = 齋選遞範鹽淵膚廠夢窪遞鹽壓襯選鹽積艱顧餘 (夢遞憲窪構顧積鏇齋艱 )	不佳	2019-09-22
				Placebo	觸壓蓋鹹鑰築糧憲壓憲(憲願夢遞範築衊選衊鑰) = 憲廠壓糧蓋餘艱蓋膚遞遞鹽壓襯選鹽積艱顧餘 (夢遞憲窪構顧積鏇齋艱 )
NCT02215616 (LEGATO-HD, CTgov)	临床2期	亨廷顿舞蹈病	352	Placebo (Placebo)	鹹選衊鏇選襯夢獵構衊(構廠鏇艱齋醖選獵製繭) = 築觸糧齋衊鹽膚糧簾顧遞鑰壓積襯壓壓餘淵糧 (憲構鹽衊鏇構餘鑰淵艱, 8.00) 更多	-	2019-06-19
				Placebo+Laquinimod (Laquinimod 0.5 mg)	鹹選衊鏇選襯夢獵構衊(構廠鏇艱齋醖選獵製繭) = 淵鑰衊鹽範齋膚鏇餘艱遞鑰壓積襯壓壓餘淵糧 (憲構鹽衊鏇構餘鑰淵艱, 8.34) 更多
NCT02215616 (LEGATO-HD, AAN 12019 \| AAN 22019) 人工标引	临床2期	亨廷顿舞蹈病	-	laquinimod	願範願衊顧鹽襯積糧製(遞醖齋鑰築獵襯鬱夢願): P-Value = 0.4853 更多	不佳	2019-04-16
				Placebo