臨床研究等提出・公開システム

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine

Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine (Sunrise)

983

The treatment groups were generally comparable with respect to demographics and baseline disease characteristics. Overall, the mean age of the participants was 42 years, 86% of participants were women, and 64% were enrolled at sites in Asia. At baseline, the mean number of monthly migraine days (MMDs) ranged from 17 to 18 days across treatment groups, and the mean number of monthly headache days (MHDs) was 20 days in each treatment group. Headache had a substantial impact on participants daily functioning, with a mean baseline HIT-6 score of 65 points in all treatment groups.

A total of 983 participants were randomized, and 978 participants received study treatment (APTS). By treatment group, 328 participants were randomized to placebo, 328 to eptinezumab 100 mg, and 327 to eptinezumab 300 mg; of these, 325, 327, and 326 participants, respectively, received study treatment. A total of 939 participants (96.0%) completed the placebo-controlled period, including 314 participants (96.6%) in the placebo group, 316 participants (96.6%) in the eptinezumab 100 mg group, and 309 participants (94.8%) in the eptinezumab 300 mg group. Overall, 39 participants (4.0%) withdrew from the trial. The primary reasons for withdrawal were adverse events (n=9), lack of efficacy (n=1), protocol violations (n=2), withdrawal of consent (n=12), and other reasons (n=15). The Full Analysis Set (FAS) comprised 972 participants, and the All-Participants-Treated Set (APTS) comprised 978 participants.

During the placebo-controlled period, the incidence of adverse events was generally similar across treatment groups. Treatment-emergent adverse events (TEAEs) were reported in 109 participants (33.5%) of participants in the placebo group, 123 participants (37.6%) in the eptinezumab 100 mg group, and 105 participants (32.2%) in the eptinezumab 300 mg group. Serious adverse events (SAEs) occurred in 4 participants (1.2%), 5 participants (1.5%), and 3 participants (0.9%) of participants, respectively, and TEAEs leading to withdrawal occurred in 2 participants (0.6%), 4 participants (1.2%), and 4 participants (1.2%) of participants, respectively. No deaths were reported. The most common TEAEs were COVID-19, nasopharyngitis, upper respiratory tract infection, and urinary tract infection. A small number of treatment-related serious adverse events, including anaphylactic reactions and hypersensitivity reactions, resulted in withdrawal from the trial. Overall, the safety, tolerability, and immunogenicity profile of eptinezumab was consistent with that previously observed, and no new safety signals were identified.

For the primary endpoint, both doses of eptinezumab demonstrated statistically significant effects relative to placebo (p<0.0001). The mean change from baseline in the number of monthly migraine days (MMDs) over Weeks 1-12 was -4.8 days in the placebo group, -7.2 days in the eptinezumab 100 mg group, and -7.5 days in the eptinezumab 300 mg group. The mean difference versus placebo was -2.4 days and -2.7 days in the eptinezumab 100 mg and 300 mg groups, respectively. For the key secondary endpoints, both doses of eptinezumab demonstrated a >=2-fold higher odds ratio versus placebo for a >=50% reduction from baseline in MMDs over Weeks 1-12 (OR=2.2 and 2.7, respectively; p<0.0001 for both) and for a >=75% reduction from baseline in MMDs over Weeks 1-4 (OR=3.9 and 4.4, respectively; p<0.0001 for both) and Weeks 1-12 (OR=2.9 and 3.0, respectively; p<0.0001 for both). Both doses of eptinezumab also demonstrated a lower Day 1 migraine rate compared with placebo (p<0.01 for both). Furthermore, improvements across patient-reported outcomes (PGIC and MBS) were greater for both doses of eptinezumab compared with placebo. The pharmacoeconomic endpoints, including HIT-6, MSQ v2.1 sub-scores, EQ-5D-5L VAS, health care resource utilization, and WPAI scores, consistently showed greater improvements in the eptinezumab groups than in the placebo group.

In this randomized, double-blind, placebo-controlled Phase III trial in chronic migraine, both doses of eptinezumab demonstrated statistically significant effects versus placebo for the primary endpoint, change from baseline in monthly migraine days over Weeks 1-12, and for all key secondary endpoints. The safety, tolerability, and immunogenicity profile was comparable to that observed previously with eptinezumab, with no new safety signals identified.

Oct. 15, 2025

https://pubmed.ncbi.nlm.nih.gov/41091746/

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031210093

Yazawa Masanari

Lundbeck Japan K.K.

Kamiyacho Prime Place, 4-1-17 Toranomon, Minato-ku, Tokyo

mnya@lundbeck.com

Narita Takanori

PPD-SNBL K.K.

Nakanoshima Daibiru 16F 3-3-23 nakanoshima, Kita-ku, Osaka

+81-80-8027-6361

Takanori.Narita@ppd.com

Complete

May. 31, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- The patient has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at screening visit with a history of migraine onset at least 12 months prior to the Screening Visit.
- The patient has had a diagnosis of migraine at <=50 years of age.
- The patient has >= 8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
- The patient fulfils the following criteria for migraine in prospectively collected information in the eDiary during the screening period:
- Migraine occurring on >=8 days and headache occurring on >=15 to <=26 days.
- The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
- The patient is aged >=18 (>=20 for Taiwan) and <=75 years at the Screening Visit.

- The patient has received any medication targeting the calcitonin generelated peptide (CGRP) pathway as preventive treatment of migraine.
- The patient has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
- The patient has a diagnosis of acute or active temporomandibular disorder.
- The patient has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
- The patient has a lifetime history of psychosis, bipolar mania, or dementia.
- Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded.
- The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Both

Migraine

Eptinezumab 100 mg, eptinezumab 300 mg or placebo administered intravenously

Change from baseline in the number of monthly migraine days (MMDs) (Weeks 1-12)
[Time Frame: Weeks 1-12]

+81-92-691-3881

Mar. 17, 2021

China/Republic of Korea/Spain/Taiwan/Georgia/Poland/Slovakia