排名前五的靶点	数量

PANX1(pannexin 1)	4
CD40L(CD40配体)	1
HER2(受体蛋白酪氨酸激酶 erbB-2)	1
CD206(巨噬细胞甘露糖受体-1)	1
CTLA4(细胞毒性T淋巴细胞相关抗原4)	1

关联

项与 Vrije Universiteit Brussel 相关的药物

Ipilimumab

伊匹木单抗

靶点

CTLA4

作用机制

CTLA4抑制剂

在研机构

Bristol Myers Squibb Co. [+17]

原研机构

Bristol Myers Squibb Co.

在研适应症

晚期肝细胞癌 [+291]

非在研适应症

复发性急性淋巴细胞白血病 [+127]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2011-03-25

TriMixDC-MEL

靶点-

作用机制-

在研机构

Universitair Ziekenhuis Brussel

原研机构

Universitair Ziekenhuis Brussel [+1]

在研适应症

黑色素瘤

非在研适应症-

最高研发阶段临床2期

首次获批国家/地区-

首次获批日期-

TriMix MEL

靶点-

作用机制

细胞毒性T淋巴细胞刺激剂 [+1]

在研机构

Vrije Universiteit Brussel

原研机构

Vrije Universiteit Brussel

在研适应症

乳腺癌 [+2]

非在研适应症

转移性黑色素瘤

最高研发阶段临床2期

首次获批国家/地区-

首次获批日期-

645

项与 Vrije Universiteit Brussel 相关的临床试验

NCT07006623

/ Not yet recruitingN/AIIT

A Multicenter Study of the Cognitive Model for Behavioral Interventions (CoMBI) as a Personalized Cognitive Behavioral Intervention for Patients With Severe Mental Illness

This observational multicenter study aims to evaluate whether the Cognitive Model for Behavioral Interventions - Severe Mental Illness (CoMBI-SMI) can reduce challenging behaviors and psychological symptoms in adults (aged 18 and older) with severe mental illness (SMI). The study is conducted across multiple sites in the Netherlands, Belgium, and the Caribbean, using a stepped-wedge design. All participating departments initially continue their usual care. At different time points, each team receives training in the CoMBI-SMI approach and begins implementing the intervention. This design allows for a comparison between standard care and CoMBI-SMI-based care.
Participants first receive their usual treatment, during which baseline data are collected on their behavior and psychological symptoms. After the care team is trained in CoMBI-SMI, participants receive CoMBI-SMI-based care for four weeks. They complete questionnaires on behavior, psychological symptoms, and quality of life before and after the intervention. The study aims to assess whether CoMBI-SMI helps reduce challenging behaviors such as aggression or repetitive actions, improve quality of life, and reduce stress for both caregivers and treatment teams. Findings from this study may help improve care for individuals with severe mental illness and provide better support for mental health professionals managing complex behaviors.

开始日期2025-09-01

申办/合作机构

Vrije Universiteit Brussel

ISRCTN45800298

/ RecruitingN/AIIT

Evaluation of the ICLEAR-EU intervention to integrate palliative care in the treatment of people with advanced chronic obstructive pulmonary disease and their family caregivers: an international stepped wedge cluster randomised controlled trial in six European countries

开始日期2025-08-01

申办/合作机构

Vrije Universiteit Brussel

NCT06879665

/ Not yet recruitingN/AIIT

TANDem-2: Closing the Gap to Interventions for TAND

The goal of this pilot study is to determine the feasibility, acceptability and impact of a brief behavioral intervention - the "Well-Beans for Caregivers" program, for adult caregivers of individuals with tuberous sclerosis complex (TSC) of any age. The main questions of the study are:
1. Can this innovative, ultra-brief caregiver well-being intervention be delivered feasibly to caregivers via an online modality?
2. How do the caregivers experience the program (acceptability)?
3. Does limited efficacy testing suggest the program has an impact on caregiver's well-being?

开始日期2025-07-15

申办/合作机构

Vrije Universiteit Brussel

[+1]

100 项与 Vrije Universiteit Brussel 相关的临床结果

登录后查看更多信息

0 项与 Vrije Universiteit Brussel 相关的专利（医药）

登录后查看更多信息

22,390

项与 Vrije Universiteit Brussel 相关的文献（医药）

2025-12-31·International Journal of Qualitative Studies on Health and Well-Being

More than meets the eye: phenomenological insights into the functioning of people with lipoedema

Article

作者: Hendrickx, Ad ; Jager-Wittenaar, Harriët ; Scafoglieri, Aldo ; Dekker, Rienk ; Eilers, Renske ; Kloosterman, Lise Maren

PURPOSE:

The aim of this study was to explore the functioning of people with lipoedema from their perspective.

METHODS:

This was a qualitative study following a phenomenological perspective using individual in-depth interviews with a convenience sample of 13 Dutch people with lipoedema. The data were analysed by using an interpretative phenomenological approach.

RESULTS:

Two overarching group experiential themes (GETs) were identified: (1) "physical complaints are only a part of their problems", and (2) "longing for improved appearance and functioning". The GETs were composed of the following subordinate GETs: "disproportionate functioning of the lower body", "navigating daily life with lipoedema", "coping with uncertainty", "the toll of shame and stigmatization", "consequences of a very negative self-image", "desire for change and improved appearance and functioning", and "an ongoing journey of acceptance".

CONCLUSIONS:

Participants experience that physical complaints affect daily activities, but with adequate adaptability, participation issues are relatively limited. Instead, shame about their appearance and (fear of) stigmatization mainly leads to social avoidance. Additionally, participants long for freedom to do what they want, wear what they want, and desire a different appearance. Therefore, the experienced level of acceptance of the condition is context- and situation-dependent and not straightforward, which is complicated by the burden of knowing that the condition is chronic.

2025-12-31·European Journal of General Practice

From trainee to general practitioner: A qualitative study of transition experiences of Flemish GP trainees

Article

作者: Tisseghem, Ellen ; Fleer, Joke ; Horlait, Melissa ; Lauwerier, Emelien ; Pype, Peter

BACKGROUND:

The transition from trainee to professional marks a key milestone in a family doctor's career, bringing both emotional and mental challenges. This critical period of specialisation shapes how young doctors adapt and influences their future career choices.

OBJECTIVES:

We explored trainees' experiences during their first year of advanced medical training in family medicine/general practice, including barriers and facilitators.

METHODS:

Using qualitative methodology, we conducted ten focus group interviews with 111 trainees. These group interviews were held as part of small-group sessions integrated into a self-guided reflection course. All interviews were held between February 2021 and March 2021, conducted online via MS Teams, recorded, and transcribed verbatim for analysis.

FINDINGS:

Our analysis uncovered two adaptational processes during this transition period: personal adaptation and professional socialisation. We interpreted this as a complex balancing act, with impact on mental health aspects such as energy, exhaustion, and self-confidence. Multiple elements at different levels influenced these processes, including the workplace (e.g. interactions with colleagues and patients), the educational program (e.g. assignments, courses), and societal expectations (e.g. role expectations, support).

CONCLUSION:

The findings highlight the importance of understanding both personal adaptation and professional socialisation to support trainees effectively during their transition into practice. Future studies should validate these findings and explore their evolution over time, particularly in relation to adaptation and career choices.

2025-12-31·BLOOD PRESSURE

Prevalence, awareness and therapeutic control of hypertension in Belgium: an opportunistic screening of nearly 6,000 participants during the May Measurement Month campaigns 2017–23

Article

作者: Delmotte, P ; Vanparys, J ; Bayet, S ; Van Der Beken, E ; Krzesinski, J. M. ; Van Nieuwenhuyse, B ; Brouwers, S ; Carlier, A ; Heuten, H ; Bondue, A ; Chabot, M ; Vanassche, T ; Van de Borne, Ph ; Robberechts, T ; Huart, J ; De Bacquer, D ; Brohée, F ; Falque, B ; Persu, A ; De Backer, T. ; Van der Niepen, P

BACKGROUND:

The May Measurement Month (MMM) initiative is an annual global screening campaign started in 2017 by the International Society of Hypertension highlighting the importance of regular measurements of blood pressure (BP). Here we report on the results of the MMM campaign done in Belgium during the month of May in 2017, 2018, 2019, 2022 and 2023.

METHODS:

Participants ≥18 years were recruited through opportunistic sampling in 12 sites (mostly hospital entrances) across Belgium. Apart from standardised BP recordings by trained staff, data were collected on demographics, lifestyle factors and comorbidities. Hypertension was defined as raised BP (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg) and/or taking antihypertensive medication.

RESULTS:

Data were collected from 5,926 participants aged 51.5 years on average. Mean (SD) systolic and diastolic BP were 125.9 (17.6) mmHg and 79.4 (10.9) mmHg with 25.8% exceeding the 140/90 mmHg threshold. Age-standardised prevalences of hypertension were 45.4% in men and 36.9% in women. Among the 2,468 individuals with hypertension, 78.5% had been previously diagnosed and 1,578 of those with known hypertension, received antihypertensive treatment. Only about half of those being treated (56.3%) did achieve the target of systolic/diastolic BP <140/90 mmHg. Inadequate therapeutic control was independently associated with increasing age and higher body mass index. Untreated hypertension was significantly associated with male sex, age, body mass index and alcohol use.

CONCLUSION:

Despite the limited representativeness of the sample, these data suggest that the 'rule of halves' for hypertension no longer holds true in Belgium and that therapeutic control of hypertension is still suboptimal.

项与 Vrije Universiteit Brussel 相关的新闻（医药）

2025-06-15

·ioncology

ASCO 巅峰对话丨殷咏梅教授、王坤教授深度对话，ASCENT-04开启TNBC一线治疗新篇章

编者按：三阴性乳腺癌（TNBC）是当前预后最差的乳腺癌亚型之一。随着近年来诊疗技术的发展，免疫治疗、抗体偶联药物（ADC）为TNBC带来了新的选择，其中靶向Trop-2 的ADC戈沙妥珠单抗（SG）已成为TNBC二线治疗的标准方案[1]。2025年美国临床肿瘤学会（ASCO）年会上，戈沙妥珠单抗联合帕博利珠单抗一线治疗PD-L1阳性TNBC的III期ASCENT-04/KEYNOTE-D19研究作为LBA，重磅披露了阳性结果，显示较标准的化疗联合免疫方案降低了35%的疾病进展或死亡风险，安全可控，奠定了ADC+免疫治疗一线应用于TNBC的基础[2]。因此，《肿瘤瞭望》于ASCO会议现场邀请江苏省人民医院殷咏梅教授与广东省人民医院王坤教授展开对话，分享对ASCENT-04研究结果的评价，展望未来TNBC一线治疗格局的发展前景。01肿瘤瞭望：此次ASCO大会公布了ASCENT-04研究的初步结果，显示了Trop-2 ADC戈沙妥珠单抗联合帕博利珠单抗一线治疗晚期TNBC的优势。首先，请您分享一下该研究的设计及主要结果。殷咏梅教授江苏省人民医院ASCENT-04研究[2]是一项全球性、多中心、开放标签、随机Ⅲ期临床研究，主要针对既往未经晚期系统治疗、无法手术的PD-L1阳性（CPS≥10）局部晚期或转移性三阴性乳腺癌（TNBC）患者，评估戈沙妥珠单抗联合帕博利珠单抗vs化疗联合帕博利珠单抗一线应用的疗效和安全性。该研究的主要终点是经盲法独立中央审查（BICR）使用RECIST v1.1确定的无进展生存期（PFS）。次要终点包括总生存期（OS）、客观缓解率（ORR）、缓解持续时间（DOR）、缓解开始时间（TTR）、患者报告结局（PROs）和安全性（图1）。图1. 研究设计该研究共纳入了443名PD-L1阳性TNBC患者，按1:1随机分组后予以戈沙妥珠单抗联合帕博利珠单抗和化疗联合帕博利珠单抗方案。该研究达到了PFS的主要研究终点，与化疗联合帕博利珠单抗相比，戈沙妥珠单抗联合帕博利珠单抗降低了疾病进展或死亡风险达35%，具有统计学显著性和临床意义（11.2个月 vs 7.8个月; HR 0.65, 95%CI 0.51-0.84; P = 0.0009）（图2上）。OS尚不成熟，但也展现了早期获益的趋势。戈沙妥珠单抗联合帕博利珠单抗方案具有更高的ORR（60% vs 53%），并显示出深度且持久的缓解（完全缓解：13% vs 8%；DOR 16.5个月 vs 9.2个月）（图2，下）。安全性方面，与既往戈沙妥珠单抗及帕博利珠单抗研究一致，未见新的不良事件信号。患者耐受性较好，戈沙妥珠单抗联合帕博利珠单抗组与化疗联合帕博利珠单抗组的不良事件相关停药率为12% vs 31%，为更多患者可以完整接受治疗带来了保障。图2. ASCENT-04研究BICR评估的PFS（上）、缓解状况（下）该研究是首次证实了ADC联合免疫治疗方案可一线应用于TNBC的Ⅲ期临床研究，为TNBC一线治疗带来了新的选择。02肿瘤瞭望：ASCENT-04研究是首次确立ADC联合免疫治疗一线应用地位的Ⅲ期研究。您如何评价该研究结果？将为晚期TNBC治疗格局带来怎样的变化？王坤教授广东省人民医院随着近年来免疫治疗的发展，国内外指南愈加强调免疫治疗联合化疗在TNBC应用的重要性，特别是对于PD-L1阳性患者，免疫治疗联合化疗已成为标准治疗方案[3,4]。此次ASCENT-04研究数据的披露，证实了对于PD-L1阳性（CPS≥10）的患者，一线戈沙妥珠单抗联合免疫治疗优于化疗联合免疫治疗。该结果既确证了Trop-2 ADC联合免疫治疗一线应用的可行性，又标志着Trop-2 ADC从此正式从TNBC二线及其后线治疗迈入一线。在免疫联合化疗作为目前TNBC一线标准治疗方案的背景下，ASCENT-04研究的阳性结果必将改写指南，改变临床实践。随着ASCENT-04研究的成功，我也期待在中国人群中开展相应的桥接研究或类似的临床研究，来验证戈沙妥珠单抗联合免疫治疗的疗效。目前江泽飞教授牵头的多中心、随机、对照的ASCENT-C04研究（图3）正在进行中，旨在探索戈沙妥珠单抗联合特瑞普利单抗对比特瑞普利单抗联合化疗一线治疗TNBC的表现，期待其结果能早日披露，为临床提供更多可能。图3. ASCENT-C04研究设计此外，近日ASCENT-03研究（NCT 05382299）披露信息显示已达到主要终点，取得了高度显著且具有临床意义的PFS改善[5]。该研究旨在验证戈沙妥珠单抗对比化疗在不适合接受PD-1/PD-L1单抗治疗的TNBC患者一线治疗的地位。戈沙妥珠单抗在TNBC一线治疗的全面突破，必将改变一线治疗的临床格局，期待戈沙妥珠单抗能够早日获批该适应症，为患者带来更多的临床治疗选择。03肿瘤瞭望：在ASCENT-04研究的基础上，您对戈沙妥珠单抗联合免疫治疗应用于中国临床实践有哪些期待？殷咏梅教授江苏省人民医院ASCENT-04研究在全球人群中确立了戈沙妥珠单抗联合帕博利珠单抗一线治疗PD-L1阳性乳腺癌的地位。该研究主要针对PD-L1阳性的TNBC患者，我相信对于该人群而言，ASCENT-04研究提供的戈沙妥珠单抗联合帕博利珠单抗方案将替代当前的化疗联合免疫治疗方案。我非常期待未来Trop-2 ADC联合免疫治疗不仅能够为患者带来ORR改善，还能为患者带来更好的总体生存获益。04肿瘤瞭望：在临床实践中，安全性管理直接影响患者生活质量及生存时间。ADC联合免疫治疗存在哪些常见的不良事件？应如何管理？王坤教授广东省人民医院ASCENT-04研究中，戈沙妥珠单抗联合帕博利珠单抗最常见不良事件为中性粒细胞减少和腹泻，未见其他新的安全信号，与既往文献报告一致，也未见间质性肺病（ILD）、眼毒性、口腔炎等不良事件，临床应用安全可控（图4）。图4. ASCENT-04研究的常见不良事件对于中性粒细胞减少，可使用粒细胞刺激因子（G-CSF）等二级预防；对于存在中性粒细胞减少高风险患者，可以使用G-CSF一级预防；若出现了严重的中性粒细胞减少伴发热，则须开始抗感染治疗。对于腹泻，可通过及时监测并对症补液、补充电解质、使用洛哌丁胺等止泻治疗有效控制[6]。此外，还需要通过患教活动等提高患者对不良事件的认知，做到早发现、早处理。参考文献：（滑动查看）[1] Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021;384(16):1529-1541. doi:10.1056/NEJMoa2028485[2] Sara M. Tolaney, et al. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. 2025 ASCO LBA 109.[3] 中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会（CSCO）乳腺癌诊疗指南2025. 人民卫生出版社-北京. 2025.04.[4] ESMO Living Guideline Metastatic Breast Cancer 2025v1.2. Available at：https://www.esmo.org/guidelines/living-guidelines/esmo-living-guideline-metastatic-breast-cancer/triple-negative-breast-cancer/de-novo-mbc-or-recurrence-6-12-months-after-the-end-of-neo-adjuvant-ici[5] Gilead Sciences, Inc. ASCENT-03: Trodelvy® Demonstrates Highly Statistically Significant & Clinically Meaningful Improvement in Progression Free Survival in Patients With First-line Metastatic Triple-Negative Breast Cancer Who Are Not Candidates for Checkpoint Inhibitors. Available at：https://www.gilead.com/news/news-details/2025/ascent-03-trodelvy-demonstrates-highly-statistically-significant--clinically-meaningful-improvement-in-progression-free-survival-in-patients-with-first-line-metastatic-triple-negative-breast[6] 中国医师协会肿瘤医师分会乳腺癌学组,中国抗癌协会国际医疗交流分会. 中国乳腺癌抗体药物偶联物安全性管理专家共识[J]. 中华肿瘤杂志,2022,44(09)：913-927.殷咏梅教授教授，主任医师，博士生导师江苏省人民医院（南京医科大学第一附属医院、江苏省妇幼保健院）副院长中国临床肿瘤学会(CSCO)副理事长北京市希思科临床肿瘤学研究基金会副理事长第19届St.Gallen国际乳腺癌大会专家团成员CSCO乳腺癌专家委员会秘书长中国抗癌协会乳腺癌专业委员会常委CSCO患者教育专家委员会主任委员CSCO BC指南执笔专家荣获2021年度，2023年度中国生物医药产业链创新风云榜“Leading Pl桂冠奖”王坤教授广东省人民医院肿瘤医院副院长博士研究生导师CSCO和CBCS乳腺癌专委会常委2019年国之名医获得者2021年NeoCART研究入选美国NCCN乳腺癌指南2023年人民好医生-乳腺癌领域杰出贡献奖获得者（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议临床结果抗体药物偶联物临床3期

2025-06-05

·医学新视点

每周一次，强效降糖！《柳叶刀》子刊：新药包含两大明星药成分，低血糖风险更低

尽管临床已有多种降糖药可选择，但仍有部分2型糖尿病患者的血糖未能得到有效控制。IcoSema是基础长效胰岛素依柯胰岛素（insulin icodec）与司美格鲁肽的固定比例联合制剂。Icodec胰岛素可与白蛋白牢固、可逆结合，形成“循环存储库”，半衰期长达196小时，从而持续稳定地释放胰岛素，从而满足患者一整周的基础胰岛素需求。业内知名机构科睿唯安（Clarivate）发布的最新Drugs to Watch™报告指出，icodec有望在五年内成为糖尿病领域的重磅创新疗法。司美格鲁肽是一种胰高糖素样肽-1（GLP-1）类似物，目前已在糖尿病治疗等代谢领域展现出亮眼疗效，备受关注。近日，IcoSema的3期临床试验（COMBINE 1）结果发表于《柳叶刀-糖尿病与内分泌学》（The Lancet Diabetes & Endocrinology），表明对于每日基础胰岛素治疗后血糖仍不达标的2型糖尿病成人患者，相比于单用基础胰岛素，每周一次的IcoSema治疗52周，糖化血红蛋白（HbA1c）水平可显著降低1.55%，且低血糖发生风险更低。有望为临床医生提供潜在有效且安全性更优的胰岛素强化治疗新策略。截图来源：The Lancet Diabetes & EndocrinologyCOMBINE 1是为期52周、开放标签、多中心、达标治疗（treat-to-target）的随机3a期试验，在全球20个国家和地区的192家医疗中心开展。研究纳入年龄≥18岁、体重指数（BMI）≤40 kg/m²、正在接受每日基础胰岛素联合或不联合口服降糖药治疗但血糖控制不佳（HbA1c在7.0%~10.0%）的成年患者1291例。研究人员将患者随机分配（1：1比例）接受每周一次皮下注射的IcoSema（含icodec 700 U/ml和司美格鲁肽2 mg/ml，646例）或单独基础胰岛素icodec（700 U/ml，645例）。基线时，患者HbA1c水平为8.22%。主要疗效终点为治疗第52周时HbA1c水平较基线的变化情况。结果显示，治疗第52周时，IcoSema组和基础胰岛素组HbA1c水平分别较基线降低了1.55%和0.89%，相比于基础胰岛素组，IcoSema组HbA1c水平多降低了0.66%（95%CI：-0.76%~-0.57%，P＜0.0001）。安全性方面，基线至第57周时，IcoSema组患者临床显著或严重低血糖事件发生率显著低于基础胰岛素组（0.14次/人-年 vs. 0.63次/人-年），IcoSema组低血糖发生风险显著降低78%（RR=0.22，95%CI：0.14~0.36，P＜0.0001）。IcoSema组常见的不良反应为胃肠道不适，而基础胰岛素组为感染。IcoSema组和基础胰岛素组的严重不良事件发生率分别为9%（59例）和11%（69例）。两组均未发生治疗相关的死亡事件。总之，本次研究结果表明，相比于基础胰岛素治疗，每周一次的IcoSema能更明显地降低HbA1c水平，且未增加严重低血糖的发生风险，有望为每日基础胰岛素治疗但血糖仍不达标的2型糖尿病患者带来有效且安全的治疗方案。点击文末“阅读原文/Read more”，即可访问The Lancet Diabetes & Endocrinology官网阅读完整论文。推荐阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料[1]Mathieu C, Lind M, Del PratoS, et al. Once-weekly IcoSema versus once-weekly insulin icodec in type 2 diabetes management (COMBINE 1): an open-label, multicentre, treat-to-target, randomised, phase 3a trial. The Lancet Diabetes & Endocrinology. Advance online publication. https://doi.org/10.1016/S2213-8587(25)00096-8[2]Clarivate Identifies Eleven Potential Blockbuster and Transformative Drugs in Annual Drugs to Watch Report. Retrieved January 9, 2025 from https://clarivate.com/news/clarivate-identifies-eleven-potential-blockbuster-and-transformative-drugs-in-annual-drugs-to-watch-report/免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com分享，点赞，在看，传递医学新知

临床结果临床3期临床成功

2025-05-12

·Firstwordpharma

Novo flexes upbeat Phase III data to support additional filings for once-weekly Sogroya in paediatric growth disorders

Novo Nordisk presented positive findings from a late-stage basket study of once-weekly Sogroya (somapacitan) at the joint congress of the European Society for Paediatric Endocrinology (ESPE) and the European Society of Endocrinology (ESE) on Monday, bolstering the growth hormone analogue’s label expansion filings in the US and EU for certain paediatric growth disorders.Specifically, Sogroya demonstrated clinical non-inferiority to once-daily Norditropin (somatropin) in pre-pubertal children born small for gestational age (SGA), or with Noonan syndrome (NS), or idiopathic short stature (ISS). The drug also showed superiority over Norditropin in children with NS and against lower doses of Norditropin in children born SGA.Highlighting the cumulative negative impact of regularly missing doses of growth hormone, Martin Lange, Novo’s executive VP for development, said: “We are committed to providing…therapies with flexibility in administration timing and missed doses, which may better suit the needs of children with growth failure.”The Phase III REAL8 trial — part of the broader REAL programme — employed a basket design to evaluate once-weekly Sogroya across four paediatric growth disorders — SGA, NS, ISS and Turner syndrome (TS). Children with NS, TS, or ISS were randomised to receive either weekly Sogroya or daily Norditropin, while those with SGA were assigned to Sogroya, or two different Norditropin doses — lower and higher than the standard dose.Results showed the study achieved its primary endpoints across three indications. In children born SGA, Sogroya demonstrated superior estimated mean height velocity compared with a lower dose of Norditropin (11.0 vs 9.4 cm/year) and non-inferior results compared with a higher dose (11.0 vs 11.1 cm/year). In children with NS, Sogroya showed superior results (10.4 vs 9.2 cm/year), while in those with ISS, it demonstrated non-inferiority (10.5 vs 10.5 cm/year) compared with Norditropin.Meanwhile, the weekly therapy showed no safety and tolerability issues compared with the daily formulation, with similar insulin-like growth factor 1 responses observed across treatment groups. Novo noted that based on the data from REAL8 and another ongoing study REAL9, it submitted marketing applications with the FDA and the EMA for the three indications last month. Results from the TS participants are expected later this year.Sogroya is currently approved to treat growth failure due to inadequate secretion of endogenous growth hormone in children aged 2.5 years and above and as a replacement for endogenous growth hormone in adults with growth hormone deficiency.

临床结果临床3期上市批准

100 项与 Vrije Universiteit Brussel 相关的药物交易

登录后查看更多信息

100 项与 Vrije Universiteit Brussel 相关的转化医学

登录后查看更多信息

组织架构

使用我们的机构树数据加速您的研究。

或

查看完整样例数据

管线布局

2025年06月25日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

药物发现

临床前

临床2期

其他

登录后查看更多信息

当前项目

药物(靶点)	适应症	全球最高研发状态

68GaNOTA-Anti-MMR-VHH2(Universitair Ziekenhuis Brussel) ( CD206 )	头颈部肿瘤更多	临床2期
TriMixDC-MEL	黑色素瘤更多	临床2期
伊匹木单抗 ( CTLA4 )	晚期恶性实体瘤更多	临床1/2期
Autologous CD1c (BDCA-1)+ myDC(Universitair Ziekenhuis Brussel)	晚期恶性实体瘤更多	临床1/2期
TriMix MEL	肝癌更多	临床1期