A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in Participants With Moderate-to-Severe Active Thyroid Eye Disease

The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.

开始日期2024-07-05

申办/合作机构

Amgen, Inc.

JPRN-jRCT2031220730

/ Recruiting临床3期IIT

A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group Multicenter Trial to Evaluate the Efficacy and Safety of HZN-001 in Treating Japanese Participants with Chronic (Inactive) Thyroid Eye Disease

开始日期2023-03-29

申办/合作机构-

NCT06674941

/ Completed临床1期

A Phase 1, Open-label, Single-dose Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Volunteers

The primary objective of this trial are to assess the pharmacokinetics (PK) of a single subcutaneous (SC) administration of teprotumumab high-concentration formula (HCF) in healthy adult non-Japanese and Japanese participants and to assess the PK of teprotumumab delivered by syringe pump and by an injection device in non-Japanese participants.

开始日期2023-03-24

申办/合作机构

Amgen, Inc.

100 项与替妥木单抗相关的临床结果

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100 项与替妥木单抗相关的转化医学

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100 项与替妥木单抗相关的专利（医药）

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307

项与替妥木单抗相关的文献（医药）

2025-01-01·JOURNAL FRANCAIS D OPHTALMOLOGIE

Article

作者: Drui, D. ; Lebranchu, P ; Ghoufi, A ; Soethoudt, M ; Mouriaux, F. ; Ben Miloud, N. ; Mouriaux, F ; Soethoudt, M. ; Bienvenu, B. ; Lebranchu, P. ; Ghoufi, A. ; Ben Miloud, N ; Bienvenu, B ; Drui, D

INTRODUCTION:

This study investigates the management of Graves'orbitopathy (GO) in France, at 26 university medical centers (CHU) as well as the Rothschild Foundation and the Quinze-Vingts national eye hospital in Paris.

METHODS:

The 28 metropolitan university medical centers were contacted by telephone or e-mail. The authors devised a 5-item questionnaire that explored the scheduling of multidisciplinary meetings, the existence or lack of a dedicated Graves' consultation service, the place of hospitalization, and first- and second-line treatments.

RESULTS:

Eighty-nine percent of hospital departments had a dedicated service for patients with GO, with 36% organizing multidisciplinary meetings. Intravenous corticosteroid therapy is still used as first-line treatment, while mycophenolate is used much less (14.3%), despite the new EUGOGO (European Group on Graves' orbitopathy) 2021 recommendations. For second-line treatment, tocilizumab is most commonly used (64%). Teprotumumab is available in France only on a compassionate basis, and its use is limited (18%).

CONCLUSION:

This study highlights the variability in practices and the importance of a multidisciplinary approach, while calling for national standardization of practices. Despite disparities in the application of recommendations, the emergence of second-line treatments such as tocilizumab and teprotumumab indicates a steady evolution in therapeutic options, although obstacles in terms of accessibility and cost remain.

2025-01-01·OPHTHALMOLOGY

The Rate of Re-treatment in Patients Treated with Teprotumumab

Article

作者: Douglas, Raymond ; Wester, Sara T ; Parunakian, Emanuil ; Ugradar, Shoaib ; Freitag, Suzanne K ; Tolentino, Joseph ; Walsh, Hannah L ; Chiou, Carolina A ; Malkhasyan, Emil

PURPOSE:

To determine the rate of re-treatment in patients who receive a full course of teprotumumab therapy for thyroid eye disease (TED) and drivers of re-treatment.

DESIGN:

Multicenter retrospective study.

PARTICIPANTS:

All patients who received a full course of treatment and had available data at 1 year after initial treatment were included.

METHODS:

Charts were reviewed for the following information: age, sex, months since diagnosis of TED, smoking status, and prior treatments. Further, the clinical activity score (CAS), proptosis, and the Gorman diplopia score were reviewed at baseline, at the end of the first course, and at baseline for the second course in those who received it. A logistic regression model was created to review the drivers of re-treatment.

MAIN OUTCOME MEASURES:

Rate of re-treatment and the drivers of re-treatment.

RESULTS:

One hundred nineteen patients were included from 3 centers across the United States. The overall re-treatment rate was 24% (29/119). No difference was found among the 3 sites (P = 0.6). In univariable analyses, at baseline, no difference was found in proptosis (P = 0.07), diplopia score (P = 0.4), or duration of TED (P = 0.4) between patients who were re-treated and those not re-treated. From the re-treated group, 82% showed a significant proptosis response (≥ 2-mm reduction from baseline) after the initial course, whereas 68% of patients who were not re-treated showed a clinically significant proptosis response (P = 0.16). The mean ± standard deviation difference between the end of the first treatment and at baseline before the second treatment (in those who received it) was 2 ± 2 for CAS, 2 ± 4 mm for proptosis, and 1 ± 1 for diplopia score. Age was the only significant driver of re-treatment (P < 0.05). Re-treated patients were 7 years older than patients who were not re-treated (60 years vs. 53 years; P < 0.05).

CONCLUSIONS:

In patients receiving a full course of teprotumumab therapy, the rate of re-treatment was 24%. Age was the only driver of re-treatment.

FINANCIAL DISCLOSURE(S):

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

2025-01-01·OPHTHALMIC PLASTIC AND RECONSTRUCTIVE SURGERY

Effects of Teprotumumab on Eyelid Retraction in Thyroid Eye Disease

Article

作者: Zhou, Jason ; Shoji, Marissa K. ; Acuff, Kaela ; Kikkawa, Don O. ; Korn, Bobby S. ; Liu, Catherine Y. ; Al-Sharif, Eman M.

Purpose::

This study evaluates the efficacy of teprotumumab in reducing eyelid retraction in thyroid eye disease (TED) patients.

Methods::

This retrospective study included patients with active or chronic moderate-to-severe TED who completed at least 4 cycles of teprotumumab. Patients with upper and/or lower eyelid retraction, defined as margin-to-reflex distance (MRD) 1 and/or MRD2 of more than 5 mm, in one or OU were included. The main outcome measure was a change in MRD1 and MRD2 after treatment. Changes in MRD1 and MRD2 were each analyzed for correlation (r) with changes in exophthalmolmetry. Student t test was performed for each comparison, and p values <0.05 were considered significant.

Results::

The study included 91 patients, predominantly female (87%), with an average age of 52.02 ± 14.6 years. The mean baseline proptosis measurement was 21.8 ± 2.9 OD and 21.7 ± 3.3 OS. The average MRD1 was 5.5 ± 1.5 OD and 5.4 ± 1.7 OS, and the average MRD2 was 6.1 ± 1.1 OD and 6.2 ± 1.1 OS. The follow-up duration post-treatment was 37.5 ± 31.7 weeks. At first follow-up post-treatment, the mean change in proptosis, MRD1, and MRD2 were −2.6 ± 2.0 OD, −2.5 ± 2.1 OS, −0.8.5 ± 1.4 OD, −0.8 ± 1.0 OS, and −0.7 ± 0.9 OD, −0.8 ± 1.0 OS, respectively. Correlation analysis showed that proptosis reduction was positively correlated with MRD1 and MRD2 reduction at the first post-treatment follow-up (MRD1: r = 0.23, p value < 0.01; MRD2: r = 0.17, p = 0.03].

Conclusion::

Teprotumumab treatment improves upper and lower eyelid retraction. The improvement in MRD correlated positively with proptosis reduction, indicating the influence of globe position on eyelid position.

308

项与替妥木单抗相关的新闻（医药）

2025-01-09

·生物制药小编

一个支柱刚倒下，另一个站起来

一个支柱管线倒下后，Acelyrin很快找到了另一个支柱。上个月，支撑Acelyrin一路走来的支柱管线Izokibep被彻底放弃开发，这条管线让这家公司不论是不论在一级市场还是二级市场都获得了大力的支持，然而，在经历一次临床失败后，迅速引起了连锁反应，股价大跌、甩锅失败、CEO辞职、裁员重组....... 不过，Acelyrin很快调整状态，重整旗鼓，把希望倾注在剩下的管线上—lonigutamab。近日，这家公司宣布，基于其lonigutamab在甲状腺眼病(TED)中的II期临床表现，公司即将开展III期临床试验，名为LONGITUDE的III期临床试验计划于今年第一季度启动，顶线数据预计2026年下半年公布。 lonigutamab是Acelyrin经历了支柱管线倒下之后唯一剩下的在研管线，也是公司能不能实现翻盘的关键。支柱管线的失败作为一家以License in为主要经营模式的Biotech公司，Acelyrin不论是在一级市场还是二级市场都相当受欢迎。 Acelyrin在成立的两年多以来完成了三轮融资，融资总额达到5.58亿美元。在二级市场，Acelyrin仍然得到了投资人的高度青睐。在2023年，以5.4亿美元融资额创下近两年来生物技术初创公司募资规模最大的一次IPO。上市当日，Acelyrin股价也大涨30.56%，市值达到21亿美元。令人诧异的是，Acelyrin如此备受资本青睐，是仅仅凭借着一条管线Izokibep。 Izokibep是一种IL-17A抑制剂，是Acelyrin于2021年11月以从Affibody收购得来（2500万美元首付款+3亿美元里程碑付款），围绕Izokibep，Acelyrin进行了银屑病关节炎 (PsA) 、化脓性汗腺炎（HS）、葡萄膜炎、中轴型脊柱关节炎 (AxSpA)多个适应症的临床开发。然而风光IPO之后几个月，这条支柱管线就遭遇临床挫折。2023年9月，Acelyrin报告了第一个临床失败消息，Izokibep治疗化脓性汗腺炎的Ⅱb/Ⅲ期临床达到临床反应（HiSCR）主要终点，这个临床失败令公司大受打击，加上之后甩锅CRO公司失败，大大的失去了投资人的信心。之后便是一系列的公司动荡，2024年5月，Acelyrin的创始人兼首席执行官Shao-Lee Lin辞职，并随之进行了33%的裁员重组。在这个重组方案中，Acelyrin对izokibep已有舍弃之心，Izokibep在的开发优先级被下调，并且在银屑病关节炎和化脓性汗腺炎两个适应症上的任何资金投入被暂停。上个月，葡萄膜炎的IIb/III期试验的失败成为了压死izokibep的最后一根稻草，最终Acelyrin宣布彻底放弃对izokibep的开发。寻找一个新支柱支柱管线的失败对Acelyrin无疑是个相当大的打击，公司的股价也从当初上市的29.8美元/股跌至3.49美元/股，下跌了89%。不过Acelyrin很快振作了起来，因为公司找到了新的希望支撑—Lonigutamab，一种靶向IGF-1R单抗，这是公司在2023年年初通过收购ValenzaBio公司所获得的管线。而能让公司对其产生信心的原因在于，Acelyrin团队对该靶点已经有了成功临床开发和商业化的先列。 Acelyrin的前创始人兼首席执行官为Shao-Lee Lin博士之前曾担任Horizon公司的首席科学官兼研发主管。而Horizon的畅销产品—Tepezza正是一款IGF-1R单抗2020年1月21日获得FDA批准上市，是目前唯一一种获得FDA批准的甲状腺眼病治疗药物。鉴于对TED患者的突眼症状效果非常显著，Tepezza进入市场后迅速实现大卖，Tepezza上市首年便斩获8.2亿美元的销售额，第二年便跻身重磅炸弹，创造了16.6亿美元的年销售额。因为手握这样的重磅产品，Horizon也成为了收购标的中的香饽饽，三大制药巨头强生、安进、赛诺菲均有意收购，最终安进在三方角逐中脱颖而出，以278亿美元巨资收购将之收入囊中，该笔收购创下了安进历年的收购记录。买进的时候，Lonigutamab尚处于临床Ⅰ期阶段，适应症也是甲状腺眼病。Acelyrin的临床推进动作也是比较快。最新公布的II期临床试验结果显示，lonigutamab在TED的眼球突出、临床活动性评分、以及Graves眼病生活质量量表都有临床意义的改善。即将开展的两项双盲、安慰剂对照的两项III期试验LONGITUDE-1和LONGITUDE-2中评估皮下注射给药lonigutamab（100mg ）后，每两周一次50mg的安全性和有效性，主要终点皆为24周的眼球突出反应率。所幸Acelyrin前期融到的钱可以支撑lonigutamab的临床开发，截至公司第三季度财报，Acelyrin持有现金5.624亿美元，预计现金储备可持续到2027年年中，足以覆盖临床试验的支出。Acelyrin还计划以3100万美元买断lonigutamab的全球权益。参考出处 https://investors.acelyrin.com/news-releases/news-release-details/acelyrin-inc-announces-additional-phase-2-data-and-phase-3 https://endpts.com/acelyrin-reports-mid-stage-win-for-potential-tepezza-challenger-in-thyroid-eye-disease/

临床3期临床2期IPO并购临床失败

2025-01-06

·EndPoints

Updated: Acelyrin’s stock drops due to mixed Phase 2 data in thyroid eye disease

Acelyrin has offered a more detailed look at mid-stage results for its thyroid eye disease drug candidate as it tees up its next development steps. In the latter part of a Phase 1/2 trial , Acelyrin’s monoclonal antibody dubbed lonigutamab produced “clinically meaningful” improvements in several TED symptoms. Out of eight patients given a 50 mg loading dose followed by 25 mg weekly administration, five had a minimum 2mm reduction from baseline in bulging of the eyeball at 12 weeks, according to a company presentation. Patients also saw improvements in double vision, Acelyrin said in Monday’s release, adding that lonigutamab was effective at lower levels of drug exposure than with other medications that also target IGF-1R. But the company’s stock $SLRN fell about 18% in after-hours trading after the data were disclosed. The results were “hardly definitive,” Jefferies analysts wrote in a Tuesday note. Patients who were treated weekly had variable eye bulging responses from weeks eight through 12 and some cohorts didn’t even achieve effective drug concentrations in the blood plasma, they explained. The dosing regimen in the Phase 2 is also different from that chosen for further development, they added. Acelyrin is gearing up for a pair of Phase 3 trials which are set to enroll a total of around 350 patients. Both LONGITUDE-1 and LONGITUDE-2 will evaluate double the loading dose given in the Phase 2, followed by a higher maintenance dose of 50 mg given at a less frequent interval of once every two weeks. Both trials will measure eyeball bulging response rates at 24 weeks as a primary endpoint. The company plans to start both studies this quarter with topline data expected in the second half of 2026. Lonigutamab’s main selling point is its subcutaneous injection approach, which could offer more convenience for patients compared with the current treatment option — Amgen’s Tepezza, which is given as an infusion. The drug could also be safer than Tepezza, which has been associated with hearing loss side effects that haven’t been seen with lonigutamab so far. Acelyrin’s Monday Phase 2 data follow positive six-week results from 12 subjects reported in March 2024. Half of those participants were given a 50 mg loading dose followed by 25 mg weekly, while the remainder were dosed with 40 mg once every three weeks. Last month, lonigutamab became Acelyrin’s lead asset after the company’s other drug candidate, izokibep, failed to hit the primary and secondary endpoints in a Phase 2b/3 trial of people with an eye disease called uveitis. Editor’s note: The headline and article were updated to add more context to the data and the company’s stock movement . It was also changed to note that Tepezza is now part of Amgen.

临床2期临床结果临床3期临床失败

2024-12-19

·求实药社

跌幅近90%！支柱管线崩塌，买买买也不管用了！

近日，Acelyrin公司宣布，其用于治疗葡萄膜炎的izokibep药物在IIb/III期试验中未能达到主要及次要终点，统计学上无显著差异，因此决定终止该药物的进一步开发。Izokibep是一种白细胞介素-17a（IL-17A）的小蛋白抑制剂，旨在通过其高效和小分子大小来克服单克隆抗体的局限性。当前，Acelyrin针对Izokibep主要研究的疾病有化脓性汗腺炎、银屑病关节炎、中轴性脊椎关节炎和葡萄膜炎。 Izokibep曾作为Acelyrin的核心支柱，极大地推动了公司的发展，并使其在资本市场，无论是一级还是二级市场，都备受投资者的青睐。然而，这次的临床挫败以及随后的一系列责任归属争议，严重削弱了投资者对Acelyrin的信心。公司股价因此遭受重创，从上市之初的29.8美元/股暴跌至3.4美元/股，跌幅高达89%。 Acelyrin曾是2023年IPO规模最大的生物医药企业，为何一年之内Acelyrin从市场宠儿成为资本弃子？买手型biotech Acelyrin成立于2020年12月，由Horizon Therapeutics（被安进以260亿美元收购）的前研发负责人Shao-Lee Lin和前首席商务官Robert F. Carey共同创立。 Horizon Therapeutics的发展史是一部成功买手的晋级之路，最为知名的药物Tepezza也是从外部买入，最终成为一款年销售额20亿美元的blockbuster，而Horizon的其他管线也是大多源自外部收购。或许是继承了Horizon的买手基因，Acelyrin采取了同样的策略，寻找并购买具有市场前景的潜在颠覆性药物，复制Tepezza的成功故事。公司目前的在研管线全部都是从外部买入： Izokibep：该药物最初是由Affibody公司研发，Acelyrin于2021年11月以2500万美元首付款和3亿美元里程碑付款的价格，引进了Izokibep的部分权益。而此前的2020年5月，国内的创响生物也引进Izokibep在大中华区、韩国的独家开发和商业化权利，以及日本外亚太地区的临床开发权利。 Lonigutamab与SLRN-517：这两款药物是Acelyrin于2023年，以收购ValenzaBio公司的形式获得。与大多数药企引进早期管线不同的是，Acelyrin公司的管线以后期为主，且均集中于自身免疫系统疾病领域，其中： Izokibep：一款白细胞介素 17A (IL-17A) 抑制剂，可以特异性结合IL-17A的两个亚基以及血清中的白蛋白，对靶点的亲和力高，分子量仅为单抗的十分之一，可以通过皮下注射，达到传统单抗静脉给药的吸收水平，同时还拥有不输于单抗的半衰期，在皮肤、关节等组织器官领域有着独特优势。 Lonigutamab ：一款皮下给药的抗IGF-1R单抗药物，通过靶向IGF-1R的一个独特表位，可以增加疗效的持久性和耐受性，目前正在开展甲状腺眼病的临床2期试验。 SLRN-517：一种靶向 c-KIT 的全人源IgG1单克隆抗体，目前处于IND申报阶段。两年累计融资11亿 2023年5月5日，Acelyrin在纳斯达克交易所上市，以每股18美元的价格发行了3000万股，募集资金5.4亿美元，是自2021年2月上市的Sana (NASDAQ:SANA)（5.88亿美元）之后，又一家募集金额超过5亿美元的Biotech公司，二者相隔达26个月之久。上市后，公司股价首日暴涨30.56%。无论是定价、发行规模，还是首日涨幅，均显示出市场对公司的高度热情，Acelyrin一定程度上带动了生物医药行业的回暖，同日生物医药科技指数（ARCA:XBI）大涨1.65%。在一级市场，Acelyrin也是受到多家知名机构追捧，完成5.58亿美元的融资，连同IPO的部分，公司在成立之后的短短25个月内，累计获得10.98亿美元的融资，Acelyrin成为Biotech行业寒冬之下的资本宠儿。 Acelyrin也是近些年为数不多的在一级市场屡创融资记录的Biotech公司。自成立以来，Acelyrin共完成了3轮融资，总融资金额达到5.58亿美元，股东不乏Venbio、Orbimed、RTW等知名机构。 Acelyrin从成立到上市，仅有短短25个月，累计获得近11亿美元的融资，且完成在纳斯达克上市，不仅融资规模上，而且在上市速度上，都是Biotech行业所罕见，尤其是在过去一年多时间的Biotech行业下行阶段，更加难能可贵，为什么Acelyrin获得资本市场的追捧？独特的商业模式。与其他专注于自研药物管线的公司不同，Acelyrin采用买手模式，收购有潜力的药物，一定程度上加快了药物研发进度。在管线的选择方面，Acelyrin不仅选择了银屑病关节炎、化脓性汗腺炎等有较大市场潜力的适应症，而且管线的研发阶段偏后期，可以在较短时间内实现药物的商业化，而商业化预期正是当下加息环境中，资本市场最为看重的亮点。甩锅CRO 加剧市场不信任 2023年9月，上市后一路高歌上涨的Acelyrin发布了izokibep治疗中度至重度化脓性汗腺炎(HS)的2b/3期试验的B部分的主要结果，数据没有实现统计学意义上的改善。不过，Acelyrin仍坚持认为izokibep显示出了早期的HiSCR100应答，且没有证据表明安全性或耐受性受到限制，但市场并不满意，股价当日暴跌54.12%。 Izokibep虽然在化脓性汗腺炎领域数据不佳，但Izokibep还在探索银屑病关节炎等其他适应症，预计在2024年一季度获得银屑病关节炎2b/3期临床数据，部分投资人依然有所期待。然而，Acelyrin的噩梦并未就此结束。去年11月，Acelyrin在更新Izokibep临床研发进展时宣称，公司发现负责临床试验的CRO公司Fortrea及其雇佣的供应商在执行时出现了重大失误，导致分组出错，剂量顺序有误，两组患者未按计划给药。其中，公司明确指出Fortrea在正进行的银屑病关节炎临床试验中存在执行错误，同时引发了Acelyrin 合理怀疑此前失败的化脓性汗腺炎3期试验是不是也存在临床执行错误。消息一出，公司股价当日暴跌32.41%。市场对于生物医药公司“谴责”CRO已经司空见惯，大多数情况下，这种谴责无非是掩盖数据不佳的托词，此外，更为重要的是Acelyrin此举对于即将发银屑病关节炎的试验数据蒙上阴影，市场也会进一步加深对Acelyrin公司的不信任。结语 Acelyrin公司在核心管线折戟后，目前已将重点转向 Lonigutamab，这是一种针对 IGF-1R 的皮下单克隆抗体，正在开发用于治疗甲状腺眼病 (TED)，并有望于 2025 年第一季度启动 Lonigutamab 的 3 期项目。截至 2024 年 9 月 30 日，ACELYRIN 还拥有强劲的财务状况，拥有 5.624 亿美元的现金、现金等价物和短期有价证券，预计将维持该公司到 2027 年中期。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。本公众号发布的各类文章重在分享，如有侵权请联系我们，我们将会删除。联系我们 I-RNA 2025 展位火热预定中！扫码立即咨询电话：13816031174 （同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多！

并购临床2期IPO临床3期

100 项与替妥木单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	替妥木单抗	L01XC	DB06343

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
格雷夫斯眼病	美国	Horizon Therapeutics Ireland DAC	2020-01-21

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
晚期乳腺癌	临床2期	美国	Hoffmann-La Roche, Inc.	2009-01-28
晚期非小细胞肺癌	临床2期	美国	Hoffmann-La Roche, Inc.	2008-11-10
晚期非小细胞肺癌	临床2期	澳大利亚	Hoffmann-La Roche, Inc.	2008-11-10
晚期非小细胞肺癌	临床2期	比利时	Hoffmann-La Roche, Inc.	2008-11-10
晚期非小细胞肺癌	临床2期	加拿大	Hoffmann-La Roche, Inc.	2008-11-10
晚期非小细胞肺癌	临床2期	法国	Hoffmann-La Roche, Inc.	2008-11-10
晚期非小细胞肺癌	临床2期	德国	Hoffmann-La Roche, Inc.	2008-11-10
晚期非小细胞肺癌	临床2期	爱尔兰	Hoffmann-La Roche, Inc.	2008-11-10
晚期非小细胞肺癌	临床2期	意大利	Hoffmann-La Roche, Inc.	2008-11-10
晚期非小细胞肺癌	临床2期	波兰	Hoffmann-La Roche, Inc.	2008-11-10

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临床结果

适应症

分期

评价

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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


OPTIC and OPTIC-X (ENDO2024)	临床2期	格雷夫斯眼病	112	Teprotumumab	艱醖鬱鑰鹽襯壓壓鹽選(蓋選餘鬱廠鬱製選淵製) = 範築淵網簾簾選齋糧膚願築廠壓膚襯鏇築醖鏇 (窪鹹餘夢廠鹽醖鬱夢壓 ) 更多	积极	2024-06-01
OPTIC and OPTIC-X (ENDO2024)	临床2期	格雷夫斯眼病	112	Teprotumumab	積觸網膚齋築簾糧積鹽(鏇艱淵範衊鹹憲蓋觸簾) = 憲鬱觸鏇憲築膚餘醖構選願壓艱衊膚築構艱鏇 (觸壓廠簾鹹淵繭齋窪積 ) 更多	积极	2024-06-01
NCT01868997 \| NCT03298867 \| JPRN-jRCT2031210453 (Three Global Randomized, Double-masked, Placebo-controlled Trials, ENDO2024)	N/A	格雷夫斯眼病	-	Teprotumumab	願簾窪築選鏇範願鬱衊(製夢淵鑰艱繭構夢範憲) = 遞鏇蓋鬱糧膚鬱遞膚膚衊壓壓構積膚範淵夢簾 (繭淵襯鑰夢鹽願築蓋範 )	积极	2024-06-01
				Placebo	願簾窪築選鏇範願鬱衊(製夢淵鑰艱繭構夢範憲) = 蓋遞鏇鹹餘鑰衊窪顧糧衊壓壓構積膚範淵夢簾 (繭淵襯鑰夢鹽願築蓋範 )
NCT04478994 (CTgov)	临床1期	弥漫性硬皮病	3	Placebo	積衊觸壓夢膚衊餘顧夢(簾顧膚繭艱鹹糧淵膚夢) = 繭製窪艱衊齋淵淵鹹襯廠鑰鏇蓋觸選艱糧壓糧 (願艱獵築衊襯選繭餘築, 憲獵構齋窪簾積膚願選 ~ 築蓋顧衊鹹襯遞範憲衊) 更多	-	2024-04-19
NCT04583735 (OR27-04, ENDO2023)	临床4期	格雷夫斯眼病	62	Teprotumumab	鏇餘獵艱繭繭醖糧鏇積(廠襯遞鏇遞繭製願膚構) = two AE discontinuations: teprotumumab (left ear conductive hearing loss with congenital anomaly) and PBO (infusion related) 餘窪鏇廠糧選鏇鏇夢窪 (遞窪醖襯選觸繭憲鏇鹽 ) 更多	积极	2023-10-05
				Placebo
ARVO2023	N/A	格雷夫斯眼病	19	Teprotumumab	鑰鬱鹹遞鏇窪蓋廠壓獵(築積廠顧簾遞簾醖鏇範) = 窪網顧夢壓糧觸蓋廠鹹齋膚簾築窪鹽鬱鹽觸憲 (簾壓膚艱鹽廠淵鑰範窪 ) 更多	-	2023-04-23
RF35 \| PSAT268 (ENDO2022)	N/A	格雷夫斯病 IGF-1R	-	Teprotumumab	窪製蓋鑰顧壓鑰鑰窪齋(齋淵製窪壓醖艱齋壓襯) = 獵鹽獵膚蓋網夢鏇窪糧淵鑰鹹壓選鹽積衊顧衊 (衊憲齋觸鏇繭夢構鹽艱, 12)	积极	2022-11-01
				Placebo	窪製蓋鑰顧壓鑰鑰窪齋(齋淵製窪壓醖艱齋壓襯) = 獵餘製構顧簾膚鏇廠遞淵鑰鹹壓選鹽積衊顧衊 (衊憲齋觸鏇繭夢構鹽艱, 15)
RF35 \| PSAT263 (ENDO2022)	临床2/3期	格雷夫斯眼病 low baseline FT4 levels	17	Teprotumumab	窪鏇餘築壓夢憲網糧醖(餘簾淵範餘網願遞餘鏇) = 顧鏇觸淵繭築選艱襯鹽襯蓋簾醖艱簾鏇遞淵築 (壓獵鏇願憲膚餘糧夢選 ) 更多	积极	2022-11-01
				Placebo	窪鏇餘築壓夢憲網糧醖(餘簾淵範餘網願遞餘鏇) = 範襯網艱襯夢積簾齋壓襯蓋簾醖艱簾鏇遞淵築 (壓獵鏇願憲膚餘糧夢選 ) 更多
PSAT261 (ENDO2022)	N/A	格雷夫斯眼病	565	Steroid Use Pre-Teprotumumab	壓鬱簾繭夢範積糧鹽網(齋積鹽繭鹽餘觸鬱製鏇) = 網繭壓齋壓鏇獵鹹壓遞鑰選顧簾範網顧餘獵獵 (構範衊鬱築艱憲鏇淵構 )	积极	2022-11-01
				Steroid Use Post-Teprotumumab	壓鬱簾繭夢範積糧鹽網(齋積鹽繭鹽餘觸鬱製鏇) = 積顧蓋壓衊鹽齋餘獵憲鑰選顧簾範網顧餘獵獵 (構範衊鬱築艱憲鏇淵構 )
ENDO2022	N/A	格雷夫斯眼病 IGF-1R antibody	-	Teprotumumab	積鬱範願糧窪獵壓廠繭(窪衊夢範網齋鏇觸襯廠) = 醖積鹽製範構鹹齋衊範餘襯廠糧齋構鹹鏇選艱 (夢製願襯獵窪網糧製範, 1358) 更多	积极	2022-11-01
				Placebo	積鬱範願糧窪獵壓廠繭(窪衊夢範網齋鏇觸襯廠) = 蓋廠獵製鏇鏇膚積積獵餘襯廠糧齋構鹹鏇選艱 (夢製願襯獵窪網糧製範, 1927) 更多