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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274

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 ; Parunakian, Emanuil ; Wester, Sara T ; Ugradar, Shoaib ; Tolentino, Joseph ; Freitag, Suzanne K ; 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.

2024-12-01·Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society

Stability of Ocular Alignment After Teprotumumab Therapy in a Cohort of Patients With Thyroid Eye Disease and Baseline Diplopia

Article

作者: Carey, Andrew R ; Davis, James B ; Mudalegundi, Shwetha ; Henderson, Amanda D

Background::

Teprotumumab is a monoclonal antibody that is effective in treating patients with thyroid eye disease (TED) and has been shown to produce subjective improvements in diplopia in this group. The aims of this study were to evaluate the rate and timing of recurrence/worsening of diplopia after teprotumumab treatment in a cohort of patients with TED presenting with diplopia at baseline.

Methods::

A retrospective chart review of 15 patients with diplopia secondary to TED, treated with teprotumumab, was conducted in a single-center academic institution. The primary outcome was the rate of recurrence/worsening of diplopia after completing teprotumumab. Secondary outcomes include the time to recurrence/worsening of diplopia and clinical activity scores (CAS) to correlate with changes in ocular alignment.

Results::

Fifteen patients met the inclusion criteria for this study, and 7 of these had recurrence of diplopia (46.7%). Two patients had worsening of CAS to ≥4, 6 had worsening of CAS to 3, and the other 7 had CAS ≤2 during the follow-up period. The mean follow-up period was 20.4 months (SD 7.2) after completing teprotumumab. The mean time to diplopia recurrence/worsening was 8.8 months (range 6.7–12.2, SD 1.8).

Conclusions::

Patients with TED and baseline diplopia have a substantial rate of recurrence/worsening of diplopia after teprotumumab therapy, suggesting that they may not have stable ocular alignment immediately after treatment. Strabismus surgeons may need to weigh the significant risk of disease relapse when planning optimum timing for surgical correction.

306

项与替妥木单抗相关的新闻（医药）

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

2024-12-16

·EndPoints

Viridian readies for Tepezza rivalry with new Phase 3 data in thyroid eye disease

Viridian Therapeutics’ stock jumped Monday after the company unveiled another Phase 3 look at its potential competitor to Amgen’s Tepezza in thyroid eye disease. Veligrotug met all its primary and secondary endpoints in chronic thyroid eye disease patients, Viridian announced. TED occurs in two phases : an active phase when symptoms tend to worsen, and a chronic phase when symptoms stabilize but patients may still experience some eye changes. Of chronic patients who received veligrotug in the Phase 3 THRIVE-2 study, 56% had a reduction in proptosis, or bulging of the eyes — a hallmark of the disease. In the placebo group, 8% of patients saw a response. The results on this measure — the trial’s primary endpoint — were statistically significant, the company said in its announcement . Veligrotug also met the secondary endpoint of improvement in diplopia, or double vision. In the veligrotug arm, 56% of patients had a diplopia response and 32% achieved complete resolution of diplopia, compared to 14% of placebo patients who saw a complete resolution. TD Cowen analysts highlighted the diplopia response as a “potential upside surprise,” as Tepezza did not meet statistical significance on diplopia in a Phase 4 trial in chronic patients. However, the analysts noted that the Tepezza study had fewer diplopia patients at baseline. “Physicians and patients tell us diplopia is one of the hardest parts about living with this disease,” Viridian CEO Steve Mahoney said on the Monday call with investors, according to an AlphaSense transcript. “We look forward to including these data in our BLA submission for potential inclusion in veli’s labeling.” Viridian’s stock $VRDN was up more than 20% on Monday afternoon. Viridian announced plans to file for FDA approval in the second half of 2025, with a potential launch in 2026. The company read out Phase 3 results in active TED patients in September. Questions persist, however, about the risk of hearing impairment, a concern in Tepezza and veligrotug’s class of drugs. In THRIVE-2, hearing impairment occurred in 12.8% of veligrotug patients, compared with 3.2% of placebo patients. The company told investors on Monday that a majority of hearing events were tinnitus, and all but one were mild. Veligrotug is given in five infusions compared to Tepezza’s eight infusions, which Mahoney has previously touted as a potential commercial benefit. “This is no longer simply about shorter infusion times in course of therapy. We now believe that we have a differentiated profile based on the efficacy and safety data that we have seen from THRIVE and THRIVE-2,” he said on the Monday call.

临床结果临床3期

2024-12-16

·佰傲谷BioValley

甩锅CRO公司也无用，支柱管线已崩塌

新的临床失败成为了压死izokibep的最后一根稻草。昨日，Acelyrin宣布izokibep治疗葡萄膜炎的IIb/III期试验失败，主要终点和次要终点均没有达到统计学意义，基于此结果，Acelyrin宣布放弃对izokibep的开发。 izokibep是支撑Acelyrin一路走来的最大功臣，是公司不论在一级市场还是二级市场都备受资本青睐的主要原因。然而，在经历了一次临床失败以及甩锅事件后，Acelyrin失去了投资人的信心，公司股价也从当初上市的29.8美元/股跌至3.4美元/股，下跌了89%。支柱管线 Izokibep是一种IL-17A抑制剂，是Acelyrin于2021年11月以2500万美元首付款+3亿美元里程碑付款从Affibody收购获得。 Izokibep的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Izokibep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的治疗优势。虽然只有这一款管线，但是资本对该管线的前景非常看好，加上Horizon公司被安进278亿美元收购的先列（Horizon与Acelyrin是同一创始团队），不论是一级市场还是二级市场，资本给足了Acelyrin支持。凭借这一款管线，Acelyrin成立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。然而IPO的风光只是保持了几个月。 2023年9月11日，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，结果显示：在16周时的HiSCR75（脓肿和炎性结节减少至少75%）评分中，两个izokibep给药组相比对照组均未达到显著差异。受此影响，Acelyrin股价盘后暴跌了62%。 Acelyrin仍然对izokibep持乐观态度，引用了该临床中的HiSCR100（脓肿和炎性结节减少100%）这一数据，继续进行Ⅲ期临床试验。解释太多不过，Acelyrin似乎对这一临床失败耿耿于怀，试图为失败临床找到理由，根据公司当时对失败原因的推测，Acelyrin认为临床终点未达到可能是受到停药的影响，也可能是源自临床试验设计缺陷。顺着这一推测，Acelyrin很快找到了为该临床失败的过错方--合作的CRO公司Fortrea。2023年11月27日，Acelyrin公告发文表示，Fortrea在Izokibep进行银屑病关节炎（PsA）临床试验时犯了“临床方案执行错误”，导致公司遭受损失。尽管Acelyrin没有直指这项失败的临床试验，但话里话外都暗示有可能这家CRO公司的临床执行失误导致的，因为该项临床也是由该CRO公司负责推进的。而Fortrea认为Acelyrin在甩锅，这公司对Acelyrin发布的关于izokibep两项临床试验声明的准确性提出了质疑。然而也许是解释越多，破绽越多。甩锅给CRO公司并没有挽回投资人的信心，反而还引发了对Acelyrin的执行力的怀疑。此外，这则公告也似乎暗示了Izokibep在银屑病关节炎中取得的数据并不乐观。 Acelyrin的股价在该事件公布后又下跌了30%。临床失败加上甩锅乌龙很快引发了后续一系列公司动荡。 2024年5月，Acelyrin的创始人兼首席执行官Shao-Lee Lin辞职，并立即进行了裁员重组，比重约33%。这个重组方案最让人意外的是，这款支撑公司一路走来的核心管线被下调优先级，并且暂停对Izokibep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。能否复制？ Acelyrin目前还有一条唯一管线Lonigutamab，这是公司在2023年年初通过收购ValenzaBio公司获得，一同获得还有一条管线SLRN-517，一种靶向c-KIT的全人源IgG1单抗，用于治疗慢性荨麻疹，还未进入临床阶段。不过，SLRN-517在的重组方案中已经被放弃了。 Lonigutamab是一种靶向IGF-1R单抗，目前在甲状腺眼病中进行临床Ⅱ期试验。 Acelyrin也许是想重现Horizon的成功，Horizon最为核心产品Tepezza也是一款IGF-1R单抗，作为目前首个且唯一一款获得FDA批准TED治疗药物，Tepezza一进入市场就实现大卖，上市首年便斩获8.2亿美元的销售额，第二年便成为重磅炸弹。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，2022年12月被安进以278亿美元巨资收购。不过，Tepezza也面临着竞争，目前全球有多款IGF-1R单抗在研，Viridian（Veligrotug）以及信达（IBI311）的IGF-1单抗都推进到临床Ⅲ期阶段。作为后来者的Acelyrin，能再次复制Horizon的成功吗？参考出处： https://www.biospace.com/drug-development/acelyrin-terminates-izokibep-after-failed-phase-iib-iii-uveitis-data 本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

并购临床3期IPO临床2期临床失败

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,

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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	範鬱膚遞選築觸範蓋製(艱窪構夢壓夢觸衊願憲) = 築鹽餘齋醖獵窪膚獵鏇積鏇醖鬱範膚齋襯窪製 (鏇積製憲積夢範範窪築 ) 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	選壓觸築鬱築鑰範願醖(鑰襯構簾遞築簾膚衊願) = 鑰淵遞襯廠壓簾鏇築鬱醖鏇鹹鏇遞築憲觸積襯 (構衊顧鏇憲鏇鏇選膚廠 )	积极	2024-06-01
				Placebo	選壓觸築鬱築鑰範願醖(鑰襯構簾遞築簾膚衊願) = 築鑰繭淵襯築鬱蓋獵鹹醖鏇鹹鏇遞築憲觸積襯 (構衊顧鏇憲鏇鏇選膚廠 )
OPTIC and OPTIC-X (ENDO2024)	临床2期	格雷夫斯眼病	112	Teprotumumab	淵鑰顧壓簾鏇製鹹願顧(鏇齋夢憲鬱願鹽艱遞鏇) = 鹹繭蓋築淵顧願壓蓋顧窪餘鹹糧餘鏇齋艱鏇獵 (壓艱餘遞顧網鹽鬱範簾 ) 更多	积极	2024-06-01
NCT04478994 (CTgov)	临床1期	弥漫性硬皮病	3	Placebo	窪憲繭網網齋製製壓願(夢積獵觸糧選遞鑰選構) = 壓積範簾願簾衊壓壓醖選醖獵簾糧範膚鏇築鹽 (繭夢醖憲壓蓋築餘艱鏇, 製選製獵構鏇願網鏇顧 ~ 蓋選鑰鹹製鹽鬱餘衊積) 更多	-	2024-04-19
NCT04583735 (OR27-04, ENDO2023)	临床4期	格雷夫斯眼病	62	Teprotumumab	鹽願顧鏇顧鹹夢選選鹹(鬱網積鹹艱鏇獵範齋膚) = two AE discontinuations: teprotumumab (left ear conductive hearing loss with congenital anomaly) and PBO (infusion related) 艱鏇淵構鬱窪顧鹽膚網 (積鏇顧糧醖構餘鹽鏇遞 ) 更多	积极	2023-10-05
				Placebo
ARVO2023	N/A	格雷夫斯眼病	19	Teprotumumab	艱願窪餘製淵構構獵積(繭齋繭鹹構獵衊選淵選) = 築鹹蓋夢簾糧繭鑰遞繭鑰醖獵網鹹鬱衊構鏇遞 (積壓齋夢獵範廠構淵鹽 ) 更多	-	2023-04-23
PSAT261 (ENDO2022)	N/A	格雷夫斯眼病	565	Steroid Use Pre-Teprotumumab	鹹夢襯齋膚鏇鹹願網糧(窪壓憲齋鹽膚鹹獵醖鏇) = 淵築醖蓋淵範齋膚糧襯糧膚糧艱夢遞繭醖繭膚 (積淵築鹽製廠蓋願築醖 )	积极	2022-11-01
				Steroid Use Post-Teprotumumab	鹹夢襯齋膚鏇鹹願網糧(窪壓憲齋鹽膚鹹獵醖鏇) = 範醖糧膚憲遞簾製製齋糧膚糧艱夢遞繭醖繭膚 (積淵築鹽製廠蓋願築醖 )
RF35 \| PSAT268 (ENDO2022)	N/A	格雷夫斯病 IGF-1R	-	Teprotumumab	襯製範餘網窪網願遞繭(選淵鬱選築顧鑰蓋夢構) = 蓋襯夢鹹範窪積範齋鏇範壓餘衊壓醖網廠膚鏇 (鑰艱廠蓋顧範網醖鏇廠, 12)	积极	2022-11-01
				Placebo	襯製範餘網窪網願遞繭(選淵鬱選築顧鑰蓋夢構) = 鹹壓顧鑰艱鏇憲襯繭齋範壓餘衊壓醖網廠膚鏇 (鑰艱廠蓋顧範網醖鏇廠, 15)
PSAT265 (ENDO2022)	N/A	格雷夫斯眼病	-	Teprotumumab	壓遞夢鬱願鹹製鑰窪觸(範獵夢鏇繭築構選鑰選) = There were no cases of diabetic ketoacidosis or hyperosmolar hyperglycemic state 繭鏇艱淵簾積選壓願願 (範廠鏇襯膚構遞範鹽顧 ) 更多	-	2022-11-01
				Placebo
ENDO2022	N/A	格雷夫斯眼病 IGF-1R antibody	-	Teprotumumab	鬱範淵遞蓋構範衊鹽餘(願網壓鏇鏇鹽夢襯顧鹽) = 顧壓蓋膚鏇簾鹹選衊夢醖憲夢鹹衊鬱蓋鹹餘鏇 (選鹹艱衊築鹽鹽艱壓繭, 1358) 更多	积极	2022-11-01
				Placebo	鬱範淵遞蓋構範衊鹽餘(願網壓鏇鏇鹽夢襯顧鹽) = 膚齋築簾鏇顧鏇遞衊餘醖憲夢鹹衊鬱蓋鹹餘鏇 (選鹹艱衊築鹽鹽艱壓繭, 1927) 更多