Biomarker and Genetic Predictors of Erenumab Treatment Response

Phase 4

Completed

Conditions: Migraine

Interventions: Drug: Erenumab

Registration Number: NCT04265755

Lead Sponsor: Amgen

Brief Summary: To explore the relationship between clinical response to erenumab and genetic biomarkers

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1406

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Erenumab	Erenumab packed in a SureClick® Autoinjector Pen (AI)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Mean MMDs Over Months 4, 5, and 6 in Relation to mPRS	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%.

Secondary Outcome Measures