(Teplizumab) - 药物靶点：CD3_在研适应症：1型糖尿病_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

hOKT3-gamma-1-ala-ala、hOKT3-γ1-ala-ala、Teplizumab (USAN/INN)

+ [6]

靶点

CD3

作用机制

CD3抑制剂(T细胞表面糖蛋白CD3复合体抑制剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

National Institute of Diabetes & Digestive & Kidney Diseases

MacroGenics, Inc.National Institute of Allergy & Infectious Diseases

最高研发阶段批准上市

首次获批日期

美国 (2022-11-17),

1型糖尿病

最高研发阶段(中国)-

特殊审评优先审评 (美国)、突破性疗法 (美国)、优先药物（PRIME） (欧盟)

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序列信息

Sequence Code 9717228L

来源: *****

Sequence Code 9976075H

来源: *****

关联

19

项与 Teplizumab 相关的临床试验

NCT04598893 / Active, not recruitingN/A

A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Recent-Onset Type 1 Diabetes Mellitus

The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.

开始日期2020-10-26

申办/合作机构-

EUCTR2018-004926-26-DE / Unknown status临床3期

A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type1 Diabetes (T1D) - PROTECT

开始日期2019-10-07

申办/合作机构

Provention Bio, Inc.

NCT03875729 / Completed临床3期

Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks..
Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.

开始日期2019-04-05

申办/合作机构

Provention Bio, Inc.

100 项与 Teplizumab 相关的临床结果

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100 项与 Teplizumab 相关的转化医学

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100 项与 Teplizumab 相关的专利（医药）

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97

项与 Teplizumab 相关的文献（医药）

2024-02-01·Expert review of clinical immunology

Teplizumab: promises and challenges of a recently approved monoclonal antibody for the prevention of type 1 diabetes or preservation of residual beta cell function

Review

作者: Kotsa, Kalliopi ; Fanaropoulou, Nina Maria ; Koufakis, Theocharis ; Tsatsani, Georgia C

INTRODUCTION:

Type 1 diabetes (T1D) is a chronic autoimmune endocrinopathy with increasing incidence that results in the depletion of pancreatic beta cells and exogenous insulin dependence. Despite technological advances in insulin delivery, disease control remains suboptimal, while previous immunotherapy options have failed to prevent T1D. Recently, teplizumab, an immunomodulating monoclonal antibody, was approved to delay or prevent T1D.

AREAS COVERED:

Five randomized controlled trials have tested different regimens of administration, mostly 14-day schemes with dose escalation. In participants with new-onset T1D, teplizumab delayed C-peptide decline, improved glycemic control, and reduced insulin demand for a median of 1 or 2 years. Studies in at-risk relatives of patients showed a decrease in T1D incidence during 2 years of follow-up. Subgroups of responders with unique metabolic and immunological characteristics were identified. Mild to moderate adverse effects were reported, including transient rash, cytopenia, nausea, vomiting, and infections.

EXPERT OPINION:

Teplizumab marks a turning point in T1D therapy. Areas of future research include the ideal population for screening, cost-effectiveness, and challenges in treatment accessibility. More studies are essential to evaluate the ideal duration of the regimen, the potential benefit of combinations with other drugs, and to identify endophenotypes with a high probability of response.

2024-01-25·Current diabetes reviews

Journey of Teplizumab: A Promising Drug in the Treatment of Type 1 Diabetes Mellitus

Article

作者: Das, Debashree Debasish ; Chawla, Pooja A ; Sharma, Nikita

Abstract::

Type 1 diabetes (T1D) is a chronic autoimmune disease caused by CD4+ and CD8+ that are activated via CD3+ cells and finally lead to the macrophages destroying the beta cells in the pancreas thereby causing diabetes. The anti-CD3 humanized monoclonal antibody was approved on 17th November 2022 by the United States Food Drug Administration (USFDA) with the name teplizumab and the brand name TZIELD. This is the only approved drug that treats type 1 diabetes (T1D) by delaying the onset of stage 3 in type 1 diabetes (T1D). This review outlines essential features of teplizumab including its brief introduction to its mechanism and other therapies for the treatment and various risks as well as the pharmacokinetics and pharmacodynamics of this disease and the clinical trial reports for the completed and ongoing therapies.

2024-01-23·Current diabetes reviews

Future is Brighter: New Potential Paradigm-Shifting Medications and Regimens for Diabetes and Obesity

Article

作者: Aliter, Kholoud F ; Aliter, Hashem F ; Al-Horani, Rami A

Abstract::

Diabetes is a chronic illness that can become debilitating owing to its microvascular and macrovascular complications. Its prevalence is increasing and so is its cost. Diabetes, particularly type 2, appears to have a very close relationship with obesity. While lifestyle modifications, exercises, and current therapeutics have substantially improved clinical outcomes, the need for new therapeutics and regimens continue to exist. Several new medications and regimens for diabetes, obesity, and diabesity are showing promising results in advanced clinical trials. For type 1 diabetes mellitus (T1DM), they include teplizumab, ustekinumab, jakinibs, and cell therapies, whereas for type 2 diabetes mellitus (T2DM), they include once-weakly insulin, tirzepatide, high oral dose of semaglutide, orforglipron, retatrutide, CagriSema, and survodutide. Given their structural and mechanistic diversity as well as their substantial efficacy and safety profiles, these medications and regimens are paradigm shifting and promise a brighter future. They will likely enable better disease prevention and management. This review will provide details about each of the above strategies to keep the scientific community up to date about progress in the fields of diabetes and obesity

259

项与 Teplizumab 相关的新闻（医药）

2024-07-01

·美通社

百年突破 | 全球首个且唯一FDA获批的延缓1型糖尿病发病的创新药Tzield®获批先行先试，落地博鳌乐城

海南博鳌 2024年7月1日 /美通社/ -- 全球首个且唯一获美国食品药品监督管理局（FDA）批准用于延缓1型糖尿病发病的创新靶向疗法Tzield ® （Teplizumab，替利珠单抗（拟））近日获批先行先试，作为临床急需的进口药品，落地海南博鳌乐城国际医疗旅游先行区（以下简称"乐城先行区"）。Teplizumab适用于延缓成人和8岁及以上儿童1型糖尿病患者从2期进展为3期 [1] 。 1型糖尿病是危害儿童健康的重大儿科内分泌疾病，自幼发病的儿童始终面临健康成长的重大威胁。作为一种CD3靶向的单克隆抗体，Teplizumab从病因上实现对胰岛β细胞的保护，进而延缓1型糖尿病发病近3年 [2] ，填补了1型糖尿病领域疾病修饰疗法的治疗空白。以1型糖尿病患者每天至少接受4次胰岛素注射为例，3年累计高达4380次，Teplizumab延缓发病近3年，可延缓进入长期胰岛素的治疗阶段，让家庭有时间做好充分的生活和知识储备，为饱受困扰的患者和家庭带来更多希望可能。博鳌乐城国际医疗旅游先行区管理局局长贾宁表示，"乐城先行区作为中国医疗领域对外开放的窗口，积极推动先行先试等各项政策用好用足，充分释放政策活力，乐城正在成为开放创新的医药产业平台，汇聚国内外优质医疗资源，为医疗质量、服务不断提升提供了强有力的支撑。赛诺菲与乐城在创新药引进、真实世界研究等方面开展了一系列高效合作，此次创新药Teplizumab成功落地乐城，是双方进一步深化合作的体现。希望未来与赛诺菲等先进国际药械企业深入探索多样化合作路径，推动更多医疗医药领域创新成果落地，持续提升患者对创新药的可及性，为人民健康提供前沿领先的医疗方案。" 赛诺菲大中华区总裁施旺表示，"Teplizumab是赛诺菲在免疫介导领域及糖尿病领域的重要战略创新产品。得益于国家对于创新药的政策支持，我们以全球领先速度实现了在乐城先行区的快速准入。从基数庞大2型糖尿病群体到亟需关注的少数1型糖尿病群体，赛诺菲关注每一个亟待满足的未尽之需，为患者实现从治到防、全年龄、全病种的呵护和关爱。未来，我们将持续在免疫领域发力，把具有突破性的药物和疫苗加速引入中国，重塑疾病防治新生态。" 低龄化趋势明显，儿童患者平均预期寿命减少我国是糖尿病第一大国。不同于大众熟知的2型糖尿病，1型糖尿病是一种慢性自身免疫性疾病，由于产生胰岛素的胰岛β细胞遭受自身免疫系统破坏，导致胰岛素"匮乏"，影响人体自身调节血糖水平的能力，发病率为1.01/10万人年 [3] ，相当于每小时约有1位患者确诊。疾病高发于10-14岁，且呈明显低年龄化趋势 [4] 。有研究显示，1型糖尿病约占儿童期各型糖尿病总数的90% [5] 。由于我国人口基数大，儿童青少年1型糖尿病患病人数排名全球第四，15岁以下发病率在过去20年内增长近4倍 [3] 。由于儿童和青少年血糖管理难度较大，血糖达标率不到20% [6] ，这使得1型糖尿病发生并发症的风险会明显增加 [4] 。与此同时，发病年龄越小，死亡风险越大，预期寿命减少越多 [7] 。有研究显示，10岁之前诊断的患者预期寿命减少16年，20岁之后诊断发病的患者预期寿命减少10年 [8] 。防治关口前移，赢回成长关键期 1型糖尿病的进展有3个分期，1期、2期尚未出现明显症状，3期阶段，人体大部分胰岛β细胞受免疫破坏，血糖水平升高达到临床糖尿病诊断标准，很多患者会出现"三多一少"的典型症状（喝水多、吃得多、尿频及不明原因的体重减轻）。儿童青少年患者病情尤其隐匿，超过50%以上的患者在确诊时已伴有糖尿病酮症酸中毒（DKA） [9] 。此时患者已处于1型糖尿病3期，体内大部分胰岛β细胞已遭受破坏。1型糖尿病的防治关口前移迫在眉睫。 2024美国糖尿病协会（ADA）指南推荐通过检测胰岛自身抗体进行筛查症状前期1型糖尿病。对于年龄≥8岁的2期1型糖尿病患者，可考虑输注Teplizumab来延缓症状性1型糖尿病（3期）发病 [10] 。中华医学会糖尿病学分会 1型糖尿病学组组长翁建平教授表示："近年来，全球1型糖尿病发病率呈上升趋势，在儿童和青少年中尤其显著。目前我国1型糖尿病的临床诊疗水平不断提升，社会政策支持持续完善，已处于国际领先水平，这是同道们多年来持续努力的成果。Teplizumab的出现，是继胰岛素诞生100年以来，1型糖尿病治疗领域的又一重大突破。依托创新疗法，通过高危人群的早筛早诊和干预，可以实现预防或延缓疾病的发生，对促进1型糖尿病防治关口前移具有重要意义。未来，期待社会各界继续携手，推动1型糖尿病管理新生态的建立。" 国家代谢性疾病临床医学研究中心主任周智广教授表示："1型糖尿病患者每天至少接受4次胰岛素注射，3年累计高达4380次，加上日常频繁的血糖监测，患者长期承受‘扎针'的痛苦，对儿童和青少年而言，疾病负担更为严重。儿童和青少年的3年，是求学发展、个体身心健康成长的‘关键3年'，跨越幼儿入园、中考、高考等重要人生阶段。Teplizumab延缓疾病近3年，为患者赢回‘成长关键期'，为家庭带来‘过渡缓冲期'，减少治疗痛苦，做好生活及知识的储备，减轻对家庭经济收入的影响，早日‘带糖'回归正常生活轨道，为未来提供更多可能。" 2022年11月，Teplizumab获美国食品药品监督管理局（FDA）批准，是FDA批准的全球首个且唯一延缓1型糖尿病发病的创新靶向疗法 [11] 。TN-10研究显示，与安慰剂组相比，持续14天使用Teplizumab治疗，能将1型糖尿病的发病时间平均延缓近3年 [2] 。2023年10月，三期临床试验研究PROTECT达到主要终点，显示Teplizumab有潜力延缓新诊断的3期1型糖尿病儿童和青少年的疾病进展 [12] 。2023年底，Teplizumab获《时代》周刊"年度最佳发明" [13] 。目前，该药已被纳入我国第四批鼓励研发申报儿童药品清单。 * Tzield®（Teplizumab）尚未获得国家药品监督管理局的上市批准，目前仅在博鳌乐城国际医疗旅游先行区指定医疗机构获批使用。 [1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761183Orig1s000lbl.pdf [2] Herold KC, Bundy BN, Long SA, et al. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes [published correction appears in N Engl J Med. 2020 Feb 6;382(6):586]. N Engl J Med. 2019;381(7):603-613. doi:10.1056/NEJMoa1902226 [3] Weng J, Zhou Z, Guo L, et al. Incidence of type 1 diabetes in China, 2010‑13: population based study[J]. BMJ, 2018, 360:j5295. DOI: 10.1136/bmj.j5295. [4] 中华医学会糖尿病学分会,中国医师协会内分泌代谢科医师分会,中华医学会内分泌学分会,等. 中国1型糖尿病诊治指南（2021版）[J]. 中华糖尿病杂志,2022,14(11)：1143-1250. [5] 中华医学会儿科学分会内分泌遗传代谢学组 , 中华儿科杂志编辑委员会. 中国儿童1型糖尿病标准化诊断与治疗专家共识（2020版）[J] . 中华儿科杂志, 2020,58(06) : 447-454. [6] Petitti DB, Klingensmith GJ, Bell RA, et al. Glycemic control in youth with diabetes: the SEARCH for diabetes in Youth Study. J Pediatr. 2009;155(5):668-72.e723. doi:10.1016/j.jpeds.2009.05.025 [7] Gregory GA, Robinson TIG, Linklater SE, et al. Global incidence, prevalence, and mortality of type 1 diabetes in 2021 with projection to 2040: a modelling study [published correction appears in Lancet Diabetes Endocrinol. 2022 Oct 7;:]. Lancet Diabetes Endocrinol. 2022;10(10):741-760. doi:10.1016/S2213-8587(22)00218-2 [8] Rawshani A, Sattar N, Franzén S, et al. Excess mortality and cardiovascular disease in young adults with type 1 diabetes in relation to age at onset: a nationwide, register-based cohort study. Lancet. 2018;392(10146):477-486. doi:10.1016/S0140-6736(18)31506-X [9] Li GH, Huang K, Dong GP, et al. Clinical Incidence and Characteristics of Newly Diagnosed Type 1 Diabetes in Chinese Children and Adolescents: A Nationwide Registry Study of 34 Medical Centers. Front Pediatr. 2022;10:888370. Published 2022 Jun 15. doi:10.3389/fped.2022.888370 [10] American Diabetes Association Professional Practice Committee. Summary of revisions:Standards of Care in Diabetes–2024. Diabetes Care 2024;47(Suppl. 1):S5–S [11] https://www.fda.gov/media/164864/download [12] Ramos EL, Dayan CM, Chatenoud L, et al. Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes. N Engl J Med. 2023;389(23):2151-2161. doi:10.1056/NEJMoa2308743 [13] https://time.com/collection/best-inventions-2023/6326916/sanofi-tzield/

临床2期疫苗临床3期

2024-06-28

·GlobeNewswire-Health Care

Tiziana Receives $3.4 Million in Non-Dilutive Funding

NEW YORK, June 28, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough therapies in neurodegenerative disease secondary to active neuroinflammatory processes today announced that it had received non-dilutive funding of $3.4 million and issued a corporate update video available here. Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences commented, “Tiziana is pleased to receive $3.4 million in non-dilutive funding to support our ongoing Phase 2 trial of intranasal foralumab in non-active secondary progressive multiple sclerosis (na-SPMS) as well as our work in Alzheimer’s Disease. We continue to explore all avenues to pursue further non-dilutive funding in the near term.” About Foralumab Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For further inquiries: Tiziana Life Sciences LtdPaul Spencer, Business Development and Investor Relations+44 (0) 207 495 2379email: info@tizianalifesciences.com Investors:Irina KofflerLifeSci Advisors, LLC646.970.4681ikoffler@lifesciadvisors.com [1] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2220272120 [2] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2309221120

临床2期免疫疗法临床结果

2024-06-26

·BioSpace

Tiziana Life Sciences to Dose First Patient with Moderate Alzheimer’s Disease with Foralumab

NEW YORK, June 26, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer’s disease. Expanded access IND’s provide a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials. Howard L. Weiner, M.D., Principal Investigator, Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital, a founding member of Mass General Brigham healthcare system stated, “I am excited to treat this first patient with moderate AD with nasal foralumab as early as July. These patients have no other treatment options including newly approved anti-amyloid drugs and continue to deteriorate. Given that nasal foralumab dampens microglial inflammation in subjects with advanced progressive MS and microglial activation is a prominent feature of Alzheimer’s disease, Tiziana is hopeful that nasal foralumab will help slow the progression of cognitive decline in this first patient. We will work closely with FDA to evaluate the treatment responses in this patient with moderate AD while we initiate our Phase 2 study Alzheimer’s Disease in patients with early symptomatic disease.” Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences commented, “In addition to our previously announced IND clearance of the Phase 2a early symptomatic Alzheimer’s Disease study, this additional FDA clearance allows Tiziana to also study intranasal foralumab in patients with moderate Alzheimer’s Disease who do not qualify for approved therapies.” Gabriele Cerrone further commented, “Foralumab could be a potentially groundbreaking treatment for Alzheimer’s disease, given it targets the disease’s underlying pathology by addressing the resulting neuroinflammation caused by the accumulation of toxic proteins in the brain.” About Foralumab Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety pro clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information please visit our website: For further inquiries: Tiziana Life Sciences Ltd Paul Spencer, Business Development and Investor Relations +44 (0) 207 495 2379 email: info@tizianalifesciences.com Investors: Irina Koffler LifeSci Advisors, LLC 646.970.4681 ikoffler@lifesciadvisors.com [1] [2]

临床2期免疫疗法临床申请

100 项与 Teplizumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09013	Teplizumab	-	DB06606

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适应症	国家/地区	公司	日期
1型糖尿病	美国	Provention Bio, Inc.	2022-11-17

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适应症	最高研发状态	国家/地区	公司	日期
葡萄糖耐受不良	临床2期	美国	National Institute of Diabetes & Digestive & Kidney Diseases	2010-08-01
葡萄糖耐受不良	临床2期	加拿大	National Institute of Diabetes & Digestive & Kidney Diseases	2010-08-01
葡萄糖耐受不良	临床2期	德国	National Institute of Diabetes & Digestive & Kidney Diseases	2010-08-01
银屑病	临床2期	美国	MacroGenics, Inc.	2009-12-01
银屑病关节炎	临床2期	美国	National Institute of Allergy & Infectious Diseases	2006-03-16

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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


NCT03875729 (PROTECT, ADA2024) 人工标引	临床3期	1型糖尿病	275	Teplizumab	鹹繭鹽壓鏇廠齋鑰蓋選(獵網艱繭繭醖壓構餘構) = 餘構鬱淵蓋衊齋夢壓觸醖糧餘構構選鏇壓築鏇 (鏇衊繭鹽選觸壓鬱範鏇, -2.27 ~ -1.87) 更多	积极	2024-06-20
				Placebo	鹹繭鹽壓鏇廠齋鑰蓋選(獵網艱繭繭醖壓構餘構) = 遞壓廠窪構鬱鏇襯網蓋醖糧餘構構選鏇壓築鏇 (鏇衊繭鹽選觸壓鬱範鏇, -1.94 ~ -1.67) 更多
NCT03875729 (PROTECT, CTgov)	临床3期	1型糖尿病	328	Placebo (Placebo)	糧鹹艱鹹觸鹽淵蓋範觸(淵蓋壓淵網齋艱鏇鹽網) = 鹽顧鹹築鏇夢積衊齋築觸鹹鑰鹹觸鑰簾繭構窪 (築壓糧積糧觸範蓋鬱鬱, 範糧觸壓膚繭網醖網繭 ~ 鹹顧糧鏇鑰糧餘獵構鏇) 更多	-	2024-04-24
				teplizumab (Teplizumab)	糧鹹艱鹹觸鹽淵蓋範觸(淵蓋壓淵網齋艱鏇鹽網) = 糧鬱獵夢願鹽壓觸艱憲觸鹹鑰鹹觸鑰簾繭構窪 (築壓糧積糧觸範蓋鬱鬱, 積鏇衊構顧鑰鏇蓋積製 ~ 齋糧構蓋繭遞壓齋繭淵) 更多
NCT03875729 (PROTECT, Pubmed)	临床3期	1型糖尿病	-	Teplizumab	鏇糧選憲衊範繭壓獵構(壓築衊築醖艱願淵淵窪) = 鹽膚壓襯網鏇簾憲鑰壓鏇醖齋餘鹹築範鹹鑰壓 (鏇製願築遞積鏇網壓簾, 0.09 ~ 0.17)	-	2023-12-07
NCT00385697 (Protégé Study, CTgov)	临床2/3期	1型糖尿病	554	Teplizumab (Open-label Herold Regimen)	膚糧蓋淵遞鑰憲廠壓廠(廠壓膚鬱蓋觸鹽築鏇願) = 鹽簾淵範淵鏇窪鹽獵壓鹹壓製窪製齋鏇膚願壓 (簾顧積範蓋艱壓憲選積, 齋夢窪憲襯憲簾壓鏇衊 ~ 窪遞壓鏇齋膚鬱積積齋) 更多	-	2023-12-05
				Teplizumab (Double-blind Herold Regimen)	壓糧製餘繭鑰繭簾願齋(鹽觸遞餘鹽艱積製窪齋) = 糧築鹹鏇醖淵選選衊艱廠齋願餘顧鹹願艱淵淵 (積構觸築夢簾顧選鹽簾, 鏇鹹鏇鏇願築餘鹽艱廠 ~ 構製鹹鏇範鑰齋窪網夢) 更多
NCT03875729 (PROTECT, Pubmed \| Br Dent J) 人工标引	临床3期	1型糖尿病	-	Teplizumab	膚壓齋淵選廠積餘蓋鬱(獵襯襯夢憲範選鑰憲蓋) = Patients treated with teplizumab (217 patients) had significantly higher stimulated C-peptide levels than patients receiving placebo (111 patients) at week 78 (least-squares mean difference, 0.13 pmol per milliliter; 95% confidence interval [CI], 0.09 to 0.17; P<0.001), and 94.9% (95% CI, 89.5 to 97.6) of patients treated with teplizumab maintained a clinically meaningful peak C-peptide level of 0.2 pmol per milliliter or greater, as compared with 79.2% (95% CI, 67.7 to 87.4) of those receiving placebo. 繭廠窪襯淵餘夢願範膚 (築齋艱獵網積構衊網齋 ) 更多	积极	2023-10-18
				placebo
NCT03751007 (Phase 1b/2a, EASD2021)	临床1/2期	1型糖尿病 C-peptide \| preproinsulin (PPI)-	-	AG019 monotherapy	範鹹網齋積範齋築鏇淵(鏇願網醖鏇鹹憲膚鬱願) = AG019 was well tolerated and safe when administered for 8 weeks as monotherapy or in association with teplizumab. No serious adverse events and no AG019 treatment discontinuation occurred due to TEAEs. Most TEAEs reported were mild (72.3%) and sometimes moderate (24.3%). AG019 safety profile was similar between adults and adolescents and there was no evidence of dose-related TEAEs. The safety profile of teplizumab in association with AG019 was consistent with that of teplizumab. 鑰觸網艱鏇鬱願觸膚鏇 (鬱鹽淵觸範糧淵壓築繭 ) 更多	积极	2021-10-01
				AG019/teplizumab combination therapy
NCT01030861 (CTgov)	临床2期	1型糖尿病 \| 葡萄糖耐受不良	76	Teplizumab (Teplizumab)	鏇鬱願積獵鹹網範糧齋(築夢獵積齋夢範膚積獵) = 願鹽選廠蓋鑰繭窪鬱鏇觸夢構艱淵觸糧積積鏇 (範築廠築繭餘簾蓋窪製, 選襯簾顧夢窪顧憲醖襯 ~ 網鏇鑰齋積蓋觸觸顧範) 更多	-	2020-08-05
				Placebo infusion (Placebo Infusion)	鏇鬱願積獵鹹網範糧齋(築夢獵積齋夢範膚積獵) = 糧鑰蓋淵襯觸顧獵襯窪觸夢構艱淵觸糧積積鏇 (範築廠築繭餘簾蓋窪製, 糧顧選壓獵艱繭願積鹽 ~ 夢積鏇觸艱鬱範鹽糧構) 更多
TrialNet teplizumab prevention trial (ADA2020)	N/A	1型糖尿病	-	Teplizumab	蓋鏇襯鹽齋願鏇觸構夢(壓範蓋糧餘鹹鏇積構鹽) = 遞網鏇積繭襯製餘簾築築壓鏇構鬱鹽廠願憲憲 (選齋繭艱獵膚壓蓋夢築 )	-	2020-06-01
ADA2020	N/A	1型糖尿病	-	Teplizumab	糧廠夢築膚範膚觸衊襯(鑰製鑰獵膚壓艱顧構憲) = 壓窪壓積窪艱衊鬱鏇淵簾鑰顧鹽艱窪築糧選鑰 (餘鏇廠蓋構顧築齋簾觸 )	-	2020-06-01
				Placebo	糧廠夢築膚範膚觸衊襯(鑰製鑰獵膚壓艱顧構憲) = 齋淵遞鬱選願夢膚襯鬱簾鑰顧鹽艱窪築糧選鑰 (餘鏇廠蓋構顧築齋簾觸 )
NCT01030861 (Pubmed \| Br Dent J) 人工标引	临床2期	1型糖尿病	76	Teplizumab	糧簾簾艱窪選憲夢齋鏇(鬱選網鹽選築觸遞範遞) = 襯憲鑰膚膚糧鏇範築製鏇窪鑰積選鬱夢獵顧壓 (夢壓衊鏇衊遞觸壓糧窪 ) 更多	积极	2019-08-15
				Placebo	糧簾簾艱窪選憲夢齋鏇(鬱選網鹽選築觸遞範遞) = 顧選糧艱憲遞願淵膚積鏇窪鑰積選鬱夢獵顧壓 (夢壓衊鏇衊遞觸壓糧窪 ) 更多