Lundbeck announced that Vyepti (eptinezumab) met the primary and all key secondary endpoints in SUNRISE, a phase III pivotal trial predominantly conducted in Asia evaluating the efficacy and safety in patients with chronic migraine. SUNRISE (NCT04921384) was an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled phase III trial, to confirm the efficacy and safety of Vyepti in participants with chronic migraine who were eligible for preventive treatment- that started in May 2021..

Lundbeck宣布Vyepti（eptinezumab）符合SUNRISE的主要和所有关键次要终点，这是一项主要在亚洲进行的III期关键试验，评估慢性偏头痛患者的疗效和安全性。SUNRISE（NCT04921384）是一项介入性，多区域，多地点，随机，双盲，安慰剂对照的III期临床试验，旨在确认Vyepti对符合预防性治疗条件的慢性偏头痛患者的疗效和安全性-始于2021年5月。。

Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days. Participants were randomly allocated to one of three treatment groups: Vyepti 300 mg, Vyepti 100 mg, or placebo. The double-blind, placebo-controlled treatment period wias followed by an extension period where all participants received active treatment to further assess the safety and tolerability of Vyepti.

慢性偏头痛定义为每月≥8天发生的偏头痛和>14天发生的头痛。参与者被随机分配到三个治疗组之一：Vyepti 300 mg，Vyepti 100 mg或安慰剂。双盲，安慰剂对照治疗期wias，然后是延长期，所有参与者均接受积极治疗，以进一步评估Vyepti的安全性和耐受性。

The total trial duration from the Screening Visit to the Safety Follow-up Visit was approximately 36 weeks and included a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Extension Period (12 weeks), and a Safety Follow-up Period (8 weeks). Participants in Japan completing the SUNRISE trial were offered to continue in the SUNSET trial (NCT05064371) which consisted of an open-label treatment of 60 weeks (five infusions),and a Safety Follow-up Period (8 weeks)..Based on the trial results Lundbeck plans to initiate discussions with relevant regulatory authorities with the aim of making Vyepti available for people suffering from migraine across Asia.

从筛查访视到安全随访访视的总试验时间约为36周，包括筛查期（28-30天），安慰剂对照期（12周），延长期（12周）和安全随访期（8周）。日本完成SUNRISE试验的参与者被要求继续进行SUNSET试验（NCT05064371），该试验包括60周的开放标签治疗（五次输注）和安全随访期（8周）。。根据试验结果，伦贝克计划与相关监管机构展开讨论，旨在为亚洲各地的偏头痛患者提供Vyepti。

In the SUNRISE trial, .

在SUNRISE审判中。

Vyepti met the primary endpoint showing statistically significant reductions in monthly migraine days (MMD) as compared with placebo. From baseline (average of 17 days) over weeks 1 through 12, mean reductions in MMDs were -7.5 for 300 mg and -7.2 for 100 mg compared to -4.8 days for placebo (p<0.0001 and p<0.0001 for 300 mg and 100 mg vs placebo, respectively).

与安慰剂相比，Vyepti达到了主要终点，显示每月偏头痛天数（MMD）在统计学上显着减少。从第1周至第12周的基线（平均17天），300 mg和100 mg的MMD平均减少为-7.5和-7.2，而安慰剂组为-4.8天（分别为300 mg和100 mg与安慰剂相比，p<0.0001和p<0.0001）。

In addition, significantly greater proportions of patients achieved ≥50% reduction in monthly migraine days over weeks 1-12 with Vyepti 300 mg and 100 mg compared to placebo. Also confirming previous efficacy findings with Vyepti, more patients treated with Vyepti achieved ≥75% reduction in MMDs compared to placebo, and the SUNRISE trial confirmed early onset of preventive effects with significantly lower proportion of patients experiencing migraine on the day following infusion with Vyepti compared to placebo.

此外，与安慰剂相比，服用Vyepti 300 mg和100 mg的患者在第1-12周每月偏头痛天数减少≥50%的比例显着增加。同样证实了Vyepti之前的疗效发现，与安慰剂相比，更多接受Vyepti治疗的患者MMD降低≥75%，SUNRISE试验证实了预防作用的早期发作，与安慰剂相比，输注Vyepti后第二天偏头痛患者的比例显着降低。

The observed safety profile of Vyepti in the SUNRISE trial was generally similar to placebo, with the most common treatment-emergent adverse events (TEAEs) being COVID-19 and nasopharyngitis. The safety profile and the rates of TEAEs with Vyepti were consistent with previously reported trials..

SUNRISE试验中观察到的Vyepti的安全性与安慰剂相似，最常见的治疗紧急不良事件（TEAE）是COVID-19和鼻咽炎。。。

Condition: Migraine/Headache

病情：偏头痛/头痛

Type: drug

类型：药物