Biomarker and Genetic Predictors of Erenumab Treatment Response

NCT ID: NCT04265755

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2023-01-18

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.

Conditions

Migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

Erenumab packed in a SureClick® Autoinjector Pen (AI)

Group Type: EXPERIMENTAL

Erenumab

Intervention Type: DRUG

Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI).

Interventions

Erenumab

Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI).

Intervention Type: DRUG

Other Intervention Names

AIMOVIG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Glostrup Hospital

Glostrup Municipality, , Denmark

Thjonustumidstod Rannsoknaverkefna

Reykjavik, , Iceland

Countries

Denmark; Iceland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

2019-002331-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20190006

Identifier Type: -

Identifier Source: org_study_id