Biomarker and Genetic Predictors of Erenumab Treatment Response

NCT04265755 | Completed Phase 4 Results

• 2 other identifiers: 201900062019-002331-28
• Study Type: interventional
• Target: 1,406
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Migraine

Keywords

Episodic and Chronic Migraine; Link between clinical response and biomarker; Phase 4

Outcome Measures

Primary Outcomes (1)

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

  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%.

  4-week Baseline Period and the last 3 months (Months 4, 5, and 6) of the 24-week Open-label Treatment Period

Study Arms (1)

Single arm

EXPERIMENTAL

Erenumab packed in a SureClick® Autoinjector Pen (AI)

Drug: Erenumab

Interventions

Erenumab DRUG

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

Also known as: AIMOVIG

Single arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (2)

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Thjonustumidstod Rannsoknaverkefna

Reykjavik, 101, Iceland

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Migraine Disorders; Recurrence

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: October 26, 2020
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: June 7, 2024
• Results First Posted: June 7, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); IC (1)