{"id":32724,"date":"2025-07-09T16:09:08","date_gmt":"2025-07-09T10:39:08","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=32724"},"modified":"2025-07-09T16:09:09","modified_gmt":"2025-07-09T10:39:09","slug":"eptinezumab-phase-iii-sunrise-trial","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/eptinezumab-phase-iii-sunrise-trial","title":{"rendered":"SUNRISE Trial: Eptinezumab Delivers Robust Migraine Prevention in Predominantly Asian Population"},"content":{"rendered":"\n<ul class=\"wp-block-list\">\n<li><em>The SUNRISE trial underscores eptinezumab\u2019s preventive efficacy and consistent tolerability profile in a largely Asian chronic migraine population, <\/em><strong><em>filling a critical data gap<\/em><\/strong><em> in global neurology care.<\/em><\/li>\n\n\n\n<li><em>Patients receiving eptinezumab were <\/em><strong><em>four times more<\/em><\/strong><em> likely to achieve a <\/em><strong><em>reduction of \u226575%<\/em><\/strong><em> in MMDs within the first 4 weeks, compared to placebo.<\/em><\/li>\n<\/ul>\n\n\n\n<p>At <strong>EAN 2025<\/strong>, Lundbeck presented new results from the <strong>SUNRISE trial (NCT04921384)<\/strong>, a pivotal Phase III randomized, placebo-controlled study evaluating eptinezumab for preventive treatment of chronic migraine in a <strong>predominantly Asian patient population<\/strong>. The trial addresses a critical unmet need, as migraine-specific treatment use and adherence remain low in Asia despite available options. SUNRISE supports expanding access to VYEPTI, approved by the FDA in <strong>2020<\/strong> and the European Commission in <strong>2022<\/strong> for adults with frequent migraines.<\/p>\n\n\n\n<p><strong>EAN 2025 Coverage: Efficacy and Safety of Eptinezumab in Chronic Migraine: Randomized Controlled Trial in a Predominantly Asian Population<\/strong><\/p>\n\n\n\n<p>SUNRISE enrolled <strong>983 adults<\/strong> (aged 18\u201375) with chronic <strong>migraine mean baseline (MMDs): 17.4 days<\/strong>, randomizing them 1:1:1 to receive a single IV dose of eptinezumab 100 mg, 300 mg, or placebo. The trial population was <strong>63.5% Asian<\/strong>, 36.5% European. All patients entered a 12-week double-blind period, followed by a 12-week dose-blind extension and an 8-week safety follow-up.<\/p>\n\n\n\n<p>Both eptinezumab doses met the primary efficacy endpoint, demonstrating significantly greater reductions in monthly migraine days compared to placebo.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td colspan=\"2\"><strong>Primary Endpoint at Week 12<\/strong><\/td><\/tr><tr><td><strong>Treatment Arm<\/strong><\/td><td><strong>Mean Change in MMDs (Weeks 1\u201312)<\/strong><\/td><\/tr><tr><td><strong>Eptinezumab 300 mg<\/strong><\/td><td>\u20137.5 days<\/td><\/tr><tr><td><strong>Eptinezumab 100 mg<\/strong><\/td><td>\u20137.2 days<\/td><\/tr><tr><td><strong>Placebo<\/strong><\/td><td>\u20134.8 days<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Patients receiving eptinezumab (300 mg or 100 mg) were four times more likely to achieve a <strong>\u226575% reduction<\/strong> in monthly migraine days within the first 4 weeks compared to placebo. Eptinezumab also showed rapid preventive efficacy, with more patients migraine-free as early as Day 1, along with greater, clinically meaningful improvements in patient-reported outcomes.<\/p>\n\n\n\n<p><strong>Safety and Tolerability<\/strong><\/p>\n\n\n\n<p>The safety profile of eptinezumab in the SUNRISE trial remained consistent with previous studies. <strong>TEAEs<\/strong> were comparable across all groups, and serious adverse events were infrequent.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Safety Endpoint<\/strong><\/td><td><strong>100 mg<\/strong><\/td><td><strong>300 mg<\/strong><\/td><td><strong>Placebo<\/strong><\/td><\/tr><tr><td><strong>Any TEAE<\/strong><\/td><td>37.6%<\/td><td>32.2%<\/td><td>33.5%<\/td><\/tr><tr><td><strong>Serious TEAEs leading to discontinuation<\/strong><\/td><td>&lt;2%<\/td><td>&lt;2%<\/td><td>&lt;2%<\/td><\/tr><tr><td><strong>Most common TEAE: COVID-19<\/strong><\/td><td>5.5%<\/td><td>4.6%<\/td><td>4.3%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Importantly, no new safety signals emerged, and eptinezumab was well tolerated, supporting its use in diverse populations.<\/p>\n\n\n\n<p><strong>KOL Views<\/strong><\/p>\n\n\n\n<p>\u201cSUNRISE reinforces eptinezumab\u2019s preventive efficacy and tolerability in chronic migraine, now validated in a predominantly Asian cohort\u2014a population historically underrepresented in migraine trials.\u201d <strong>\u2013 Expert Opinion.<\/strong><\/p>\n\n\n\n<p>\u201cRapid onset from Day 1 and sustained MMD reduction through Week 12 are important for real-world management. These results further support eptinezumab\u2019s role in high-burden chronic migraine patients globally.\u201d <strong>\u2013 Expert Opinion.<\/strong><\/p>\n\n\n\n<p><strong>Conclusion<\/strong><\/p>\n\n\n\n<p>The SUNRISE trial provides compelling new evidence that <strong>eptinezumab 100 mg and 300 mg<\/strong> are effective, well-tolerated preventive options for <strong>chronic migraine<\/strong>, with demonstrated benefit in a predominantly <strong>Asian population<\/strong>. The trial strengthens eptinezumab\u2019s global clinical profile and underscores the need for <strong>geographically inclusive research<\/strong> in neurology. With rapid onset, sustained efficacy, and quarterly dosing convenience, eptinezumab continues to set a high standard in migraine prevention.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>At EAN 2025, Lundbeck presented new results from the SUNRISE trial (NCT04921384), a pivotal Phase III randomized, placebo-controlled study evaluating eptinezumab for preventive treatment of chronic migraine in a predominantly Asian patient population. The trial addresses a critical unmet need, as migraine-specific treatment use and adherence remain low in Asia despite available options. SUNRISE supports [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":32726,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17126],"tags":[22601],"industry":[17225],"therapeutic_areas":[17245],"class_list":["post-32724","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-others","tag-ean-annual-congress","industry-pharmaceutical","therapeutic_areas-neurology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Eptinezumab Phase III SUNRISE Trial | EAN 2025<\/title>\n<meta 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