<p><img src="https://imageproxy.pbkrs.com/https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2025/12/argenxdiscta16dec-shutterstock_2108613743-428x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="428" height="241" original-src="https://imageproxy.pbkrs.com/https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2025/12/argenxdiscta16dec-shutterstock_2108613743-428x241.jpg"/></p>
<p>argenx 计划在试验结束和数据库锁定后进行全面的数据分析。来源：Wirestock Creators / Shutterstock.com。</p>
<p>argenx 已宣布停止针对中重度甲状腺眼病（TED）成人患者的 efgartigimod 皮下（SC）（efgartigimod alfa 和 hyaluronidase-qvfc）III 期 UplighTED 试验。</p>
<p>这一停止决定是基于独立数据监测委员会（IDMC）的建议，该委员会在审查了预先指定的中期分析的中期数据后，建议因无效性停止研究。</p>
<p>该建议是基于对在 III 期试验中完成 24 周的参与者的非盲数据的分析。</p>
<p><img src="https://imageproxy.pbkrs.com/https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="130" height="183" original-src="https://imageproxy.pbkrs.com/https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png"/></p>
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<p>然而，该疗法显示出令人鼓舞的耐受性和安全性，并未观察到新的安全信号。</p>
<p>公司计划在研究结束和数据库锁定后进行全面的数据分析。</p>
<p>该分析旨在提高对研究结果的理解，并识别可能为未来 TED 研究提供信息的生物学见解。</p>
<p>公司还指出，来自已停止研究的数据将在即将召开的医学会议上进行展示。</p>
<p>III 期安慰剂对照、双盲、多中心、随机试验旨在评估 efgartigimod PH20 SC 通过预填充注射器在 TED 患者中的安全性、有效性、药代动力学、耐受性、药效学和免疫原性。</p>
<p>参与研究的患者有与自身免疫性甲状腺疾病相关的活动性中重度 TED，包括格雷夫斯病或桥本甲状腺炎。</p>
<p>他们被随机分配为 2:1 的比例，接受治疗或安慰剂 PH20 SC，在双盲治疗阶段进行。</p>
<p>在第 24 周时，反应性突眼症参与者的百分比是主要目标。</p>
<p>关键次要终点包括研究眼从基线到第 24 周的突眼测量变化、从基线到第 24 周的总格雷夫斯眼眶病生活质量（GO-QoL）评分变化，以及在同一期间内双视症状消失的受试者百分比。</p>
<p>argenx 首席医学官 Luc Truyen 表示：“我们对研究未能达到预期结果感到失望，特别是对那些生活在 TED 中的患者表示同情，他们在寻求这种具有挑战性的疾病的新疗法。”</p>
<p>“我们预先计划了这项无效性分析，因为它提供了对观察到的患者结果的有意义的中期评估，并使我们能够负责任地评估研究未来成功的可能性。这种方法是我们在临床开发项目中对投资和资源进行有序和负责任管理的基础。”</p>
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ARGX

<p>argenx 宣布因独立数据监测委员会的建议，因无效性停止对中重度甲状腺眼病（TED）成人患者进行的 III 期 UplighTED 试验。尽管试验中止，该疗法显示出良好的安全性。将对试验数据进行全面分析，以获取未来研究的见解。相关数据将在即将举行的医学会议上发布</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2025/12/argenxdiscta16dec-shutterstock_2108613743-428x241.jpg" alt="" original-src="https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2025/12/argenxdiscta16dec-shutterstock_2108613743-428x241.jpg"/></p>
<p>argenx plans to carry out a comprehensive analysis of the trial data after the close out and the database lock. Credit: Wirestock Creators / Shutterstock.com.</p>
<div class="lb-trans"><p>argenx 计划在试验结束和数据库锁定后进行全面的数据分析。来源：Wirestock Creators / Shutterstock.com。</p>
</div><p>argenx has announced the discontinuation of the Phase III UplighTED trials of efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adult patients with moderate to severe thyroid eye disease (TED).</p>
<div class="lb-trans"><p>argenx 已宣布停止针对中重度甲状腺眼病（TED）成人患者的 efgartigimod 皮下（SC）（efgartigimod alfa 和 hyaluronidase-qvfc）III 期 UplighTED 试验。</p>
</div><p>The discontinuation follows advice from an Independent Data Monitoring Committee (IDMC), which recommended halting the studies for futility after reviewing interim data from a pre-specified interim analysis.</p>
<div class="lb-trans"><p>这一停止决定是基于独立数据监测委员会（IDMC）的建议，该委员会在审查了预先指定的中期分析的中期数据后，建议因无效性停止研究。</p>
</div><p>This recommendation was based on an analysis of unblinded data from those who had completed 24 weeks in the Phase III trials.</p>
<div class="lb-trans"><p>该建议是基于对在 III 期试验中完成 24 周的参与者的非盲数据的分析。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png" alt="" original-src="https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png"/></p>
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</div><p>However, the therapy demonstrated an encouraging tolerability and safety profile, and no new safety signals were observed.</p>
<div class="lb-trans"><p>然而，该疗法显示出令人鼓舞的耐受性和安全性，并未观察到新的安全信号。</p>
</div><p>The company plans to perform a comprehensive analysis of the trial data after the study closes out and the database is locked.</p>
<div class="lb-trans"><p>公司计划在研究结束和数据库锁定后进行全面的数据分析。</p>
</div><p>This analysis aims to improve understanding of the study results and identify biological insights that could inform future research in TED.</p>
<div class="lb-trans"><p>该分析旨在提高对研究结果的理解，并识别可能为未来 TED 研究提供信息的生物学见解。</p>
</div><p>The company also noted that data from the discontinued studies will be presented at an upcoming medical meeting.</p>
<div class="lb-trans"><p>公司还指出，来自已停止研究的数据将在即将召开的医学会议上进行展示。</p>
</div><p>The Phase III placebo-controlled, double-masked, multi-centre, randomised trials are aimed at assessing the safety, efficacy, pharmacokinetics, tolerability, pharmacodynamics, and immunogenicity of efgartigimod PH20 SC administered via prefilled syringe in those with TED.</p>
<div class="lb-trans"><p>III 期安慰剂对照、双盲、多中心、随机试验旨在评估 efgartigimod PH20 SC 通过预填充注射器在 TED 患者中的安全性、有效性、药代动力学、耐受性、药效学和免疫原性。</p>
</div><p>Participants in the studies had active, moderate-to-severe TED linked to autoimmune thyroid conditions, including Graves’ disease or Hashimoto’s thyroiditis.</p>
<div class="lb-trans"><p>参与研究的患者有与自身免疫性甲状腺疾病相关的活动性中重度 TED，包括格雷夫斯病或桥本甲状腺炎。</p>
</div><p>They were randomised into a 2:1 ratio and given either the therapy or placebo PH20 SC during the double-blinded treatment phase.</p>
<div class="lb-trans"><p>他们被随机分配为 2:1 的比例，接受治疗或安慰剂 PH20 SC，在双盲治疗阶段进行。</p>
</div><p>The percentage of participants who were proptosis responders at week 24 is the primary goal.</p>
<div class="lb-trans"><p>在第 24 周时，反应性突眼症参与者的百分比是主要目标。</p>
</div><p>Key secondary endpoints included changes in proptosis measurement in the study eye from baseline to week 24, changes in the total Graves’ Orbitopathy Quality of Life (GO-QoL) score from baseline to week 24, and the percentage of subjects with resolution of diplopia during the same period.</p>
<div class="lb-trans"><p>关键次要终点包括研究眼从基线到第 24 周的突眼测量变化、从基线到第 24 周的总格雷夫斯眼眶病生活质量（GO-QoL）评分变化，以及在同一期间内双视症状消失的受试者百分比。</p>
</div><p>argenx chief medical officer Luc Truyen said: “We are disappointed the studies did not meet our desired outcome, and we especially empathise with patients who are living with TED and seeking new therapies for this challenging disease.</p>
<div class="lb-trans"><p>argenx 首席医学官 Luc Truyen 表示：“我们对研究未能达到预期结果感到失望，特别是对那些生活在 TED 中的患者表示同情，他们在寻求这种具有挑战性的疾病的新疗法。”</p>
</div><p>“We had pre-planned this futility analysis as it provides a meaningful interim evaluation of observed patient outcomes and enables us to responsibly evaluate the study’s future likelihood of success. This approach is fundamental to our disciplined and responsible stewardship of investment and resources in our clinical development programmes.”</p>
<div class="lb-trans"><p>“我们预先计划了这项无效性分析，因为它提供了对观察到的患者结果的有意义的中期评估，并使我们能够负责任地评估研究未来成功的可能性。这种方法是我们在临床开发项目中对投资和资源进行有序和负责任管理的基础。”</p>
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Argenx 将终止甲状腺相关眼病治疗的三期临床试验