Biomarker and Genetic Predictors of Erenumab Treatment Response

Migraine Clinical Trial

— INTERROGATE  

Official title:

Biomarker and Genetic Predictors of Erenumab Treatment Response, a Phase 4 Investigational Open-label Study (INTERROGATE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265755
• Other study ID #: 20190006
• Secondary ID: 2019-002331-28
• Status: Completed
• Phase: Phase 4
• Start date: October 26, 2020
• Est. completion date: January 18, 2023

Study information

• Verified date: December 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 1406
• Est. completion date: January 18, 2023
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
Denmark	Glostrup Hospital	Glostrup
Iceland	Thjonustumidstod Rannsoknaverkefna	Reykjavik

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Denmark,  Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   AmgenTrials clinical trials website