<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 計劃在試驗結束和數據庫鎖定後進行全面的數據分析。來源：Wirestock Creators / Shutterstock.com。</p>
<p>argenx 已宣佈停止針對中重度甲狀腺眼病（TED）成人患者的 efgartigimod 皮下（SC）（efgartigimod alfa 和 hyaluronidase-qvfc）III 期 UplighTED 試驗。</p>
<p>這一停止決定是基於獨立數據監測委員會（IDMC）的建議，該委員會在審查了預先指定的中期分析的中期數據後，建議因無效性停止研究。</p>
<p>該建議是基於對在 III 期試驗中完成 24 周的參與者的非盲數據的分析。</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，該療法顯示出令人鼓舞的耐受性和安全性，並未觀察到新的安全信號。</p>
<p>公司計劃在研究結束和數據庫鎖定後進行全面的數據分析。</p>
<p>該分析旨在提高對研究結果的理解，並識別可能為未來 TED 研究提供信息的生物學見解。</p>
<p>公司還指出，來自已停止研究的數據將在即將召開的醫學會議上進行展示。</p>
<p>III 期安慰劑對照、雙盲、多中心、隨機試驗旨在評估 efgartigimod PH20 SC 通過預填充注射器在 TED 患者中的安全性、有效性、藥代動力學、耐受性、藥效學和免疫原性。</p>
<p>參與研究的患者有與自身免疫性甲狀腺疾病相關的活動性中重度 TED，包括格雷夫斯病或橋本甲狀腺炎。</p>
<p>他們被隨機分配為 2:1 的比例，接受治療或安慰劑 PH20 SC，在雙盲治療階段進行。</p>
<p>在第 24 周時，反應性突眼症參與者的百分比是主要目標。</p>
<p>關鍵次要終點包括研究眼從基線到第 24 周的突眼測量變化、從基線到第 24 周的總格雷夫斯眼眶病生活質量（GO-QoL）評分變化，以及在同一期間內雙視症狀消失的受試者百分比。</p>
<p>argenx 首席醫學官 Luc Truyen 表示：“我們對研究未能達到預期結果感到失望，特別是對那些生活在 TED 中的患者表示同情，他們在尋求這種具有挑戰性的疾病的新療法。”</p>
<p>“我們預先計劃了這項無效性分析，因為它提供了對觀察到的患者結果的有意義的中期評估，並使我們能夠負責任地評估研究未來成功的可能性。這種方法是我們在臨牀開發項目中對投資和資源進行有序和負責任管理的基礎。”</p>
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ARGX

<p>argenx 宣佈因獨立數據監測委員會的建議，因無效性停止對中重度甲狀腺眼病（TED）成人患者進行的 III 期 UplighTED 試驗。儘管試驗中止，該療法顯示出良好的安全性。將對試驗數據進行全面分析，以獲取未來研究的見解。相關數據將在即將舉行的醫學會議上發佈</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 計劃在試驗結束和數據庫鎖定後進行全面的數據分析。來源：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 已宣佈停止針對中重度甲狀腺眼病（TED）成人患者的 efgartigimod 皮下（SC）（efgartigimod alfa 和 hyaluronidase-qvfc）III 期 UplighTED 試驗。</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>這一停止決定是基於獨立數據監測委員會（IDMC）的建議，該委員會在審查了預先指定的中期分析的中期數據後，建議因無效性停止研究。</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>該建議是基於對在 III 期試驗中完成 24 周的參與者的非盲數據的分析。</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 class="lb-trans"><p>探索我們為您精心挑選的報告樣本，獲取內部見解的預覽。今天就下載您的免費副本。</p>
</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，該療法顯示出令人鼓舞的耐受性和安全性，並未觀察到新的安全信號。</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>公司計劃在研究結束和數據庫鎖定後進行全面的數據分析。</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>該分析旨在提高對研究結果的理解，並識別可能為未來 TED 研究提供信息的生物學見解。</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>公司還指出，來自已停止研究的數據將在即將召開的醫學會議上進行展示。</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 期安慰劑對照、雙盲、多中心、隨機試驗旨在評估 efgartigimod PH20 SC 通過預填充注射器在 TED 患者中的安全性、有效性、藥代動力學、耐受性、藥效學和免疫原性。</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>參與研究的患者有與自身免疫性甲狀腺疾病相關的活動性中重度 TED，包括格雷夫斯病或橋本甲狀腺炎。</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>他們被隨機分配為 2:1 的比例，接受治療或安慰劑 PH20 SC，在雙盲治療階段進行。</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 周時，反應性突眼症參與者的百分比是主要目標。</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>關鍵次要終點包括研究眼從基線到第 24 周的突眼測量變化、從基線到第 24 周的總格雷夫斯眼眶病生活質量（GO-QoL）評分變化，以及在同一期間內雙視症狀消失的受試者百分比。</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 首席醫學官 Luc Truyen 表示：“我們對研究未能達到預期結果感到失望，特別是對那些生活在 TED 中的患者表示同情，他們在尋求這種具有挑戰性的疾病的新療法。”</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>“我們預先計劃了這項無效性分析，因為它提供了對觀察到的患者結果的有意義的中期評估，並使我們能夠負責任地評估研究未來成功的可能性。這種方法是我們在臨牀開發項目中對投資和資源進行有序和負責任管理的基礎。”</p>
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Argenx 將終止甲狀腺相關眼病治療的三期臨牀試驗