Biomarker and Genetic Predictors of Erenumab Treatment Response, a Phase 4 Investigational Open-label Study (INTERROGATE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 1,406
- 试验地点
- 2
- 主要终点
- Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Mean MMDs Over Months 4, 5, and 6 in Relation to mPRS
研究概览
简要总结
To explore the relationship between clinical response to erenumab and genetic biomarkers
详细描述
This is a phase 4 open-label study aiming to explore the relationship between clinical response to erenumab and genetic biomarkers.
Subjects with episodic or chronic migraine will be treated with Erenumab 70mg or 140mg for a 4-week baseline/screening period, followed by a 24-week treatment period.
Subjects will collect migraine-related parameters daily using an eDiary and blood samples will be collected for biomarker research. All analysis will be descriptive in nature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- •Age greater than or equal to 18 years upon entry into screening
- •History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self report
- •Greater than or equal to 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening After baseline period
- •Must have demonstrated greater than or equal to 75% compliance in eDiary usage during baseline period
排除标准
- •Subjects are excluded from the study if any of the following criteria apply:
- •Disease Related
- •Greater than 50 years of age at migraine onset
- •History of cluster headache or hemiplegic migraine headache
- •Inability to differentiate between migraine from other headaches. Other Medical Conditions
- •The subject is at risk of self-harm or harm to others as evidenced by past suicidal behaviour
- •History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- •Prior/Concomitant Therapy
- •Previously received erenumab (Aimovig®)
- •Received an anti-CGRP monoclonal antibody within 3 months prior to the start of the baseline period
- •Initiation, discontinuation, or change of dosing of migraine prophylactic medications within 2 months prior to the start of the baseline period, during the baseline period or planned during the study.
- •Prior/Concurrent Clinical Study Experience
- •Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study (ies). Other investigational procedures while participating in this study are excluded.
- •Other Exclusions
- •Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test
- •Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product
- •Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product
- •Evidence of current pregnancy or breastfeeding per subject self-report or medical records
- •Subject has known sensitivity to any of the products or components to be administered during dosing
- •Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge
研究组 & 干预措施
Single arm
Erenumab packed in a SureClick® Autoinjector Pen (AI)
干预措施: Erenumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Mean MMDs Over Months 4, 5, and 6 in Relation to mPRS
时间窗: 4-week Baseline Period and the last 3 months (Months 4, 5, and 6) of the 24-week Open-label Treatment Period
A migraine day was defined as a calendar day (00:00 to 23:59) in which the participant reports any migraine headache or takes any triptan-based acute migraine-specific medication. At least a 50% reduction from Baseline in MMDs was determined if: (average number of migraine days per month during the last 3 months \[months 4, 5, and 6\] of the 24-week Open-label Treatment Period minus number of migraine days during the 4-week Baseline Period) / number of migraine days during the 4-week Baseline Period \* 100, was less than or equal to -50%.
次要结局
未报告次要终点