Biomarker and Genetic Predictors of Erenumab Treatment Response (INTERROGATE)

January 18, 2023 updated by: Amgen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1406

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Glostrup Hospital
  • Iceland
      • Reykjavik, Iceland, 101
        • Thjonustumidstod Rannsoknaverkefna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
Erenumab packed in a SureClick® Autoinjector Pen (AI)
Drug: Erenumab
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of at least a 50% reduction from baseline in mean monthly migraine days (MMD) in relation to each individual genome-wide significant single-nucleotide polymorphism (SNP) contributing to the migraine polygenic risk score (mPRS)
Time Frame: From baseline over months 4, 5, and 6
To explore the relationship between clinical response to erenumab and genetic biomarkers
From baseline over months 4, 5, and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2020

Primary Completion (Actual)

January 18, 2023

Study Completion (Actual)

January 18, 2023

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 12, 2020

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190006
  • 2019-002331-28 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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