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    Summary
    EudraCT Number:2019-003646-33
    Sponsor's Protocol Code Number:20190008
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-03-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-003646-33
    A.3Full title of the trial
    Comprehensive Assessment of Erenumab Efficacy in Subjects With High Frequency Episodic Migraine With at Least 1 Previously Failed Preventive Treatment: a Global, Double-blind, Placebo-controlled Phase 4 Study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Erenumab – Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine.
    A.3.2Name or abbreviated title of the trial where available
    EMBRACE
    A.4.1Sponsor's protocol code number20190008
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen Biotechnologia Sp. z o.o.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street Addressul. Pulawska 145
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code02-715
    B.5.3.4CountryPoland
    B.5.4Telephone number+48 22 581 30 00
    B.5.5Fax number+48 22 581 30 01
    B.5.6E-mailmedinfo-pol@amgen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Aimovig
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAMG 334 PFS
    D.3.2Product code AMG 334
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1582205-90-0
    D.3.9.2Current sponsor codeAMG 334
    D.3.9.4EV Substance CodeSUB74690
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    High frequency episodic migraine
    E.1.1.1Medical condition in easily understood language
    Migraine
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027599
    E.1.2Term Migraine
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key inclusion criteria include:
    • Age ≥ 18 years upon entry into initial screening
    • Documented history of migraine with or without aura according to the
    International Headache Society (IHS) International Classification of
    Headache Disorders, Third Edition (ICHD-III) for ≥ 12 months
    • Have HFEM: Defined as history of ≥ 7 to < 15 migraine days and < 15
    headache days per month on average during the 3 months prior to
    screening
    • History of ≥ 4 migraine attacks of at least moderate severity per
    month on average during the 3 months prior to screening
    • History of treatment failure with at least 1 preventive treatment for
    migraine. Failure of preventive treatment for migraine is defined as
    treatment discontinuation due to lack of efficacy, adverse event, or
    general poor tolerability.
    • Regular use of an oral triptan (using only eletriptan, rizatriptan,
    sumatriptan, or zolmitriptan) for acute migraine treatment, and typically
    initiating acute treatment with an oral triptan on > 50% of attacks of at
    least moderate pain intensity. Regular use is defined as ≥ 4 days of oral
    triptan use per month during the 3 months prior to screening.
    E.4Principal exclusion criteria
    Key exclusion criteria include:
    • History of hemiplegic migraine, cluster headache, or other trigeminal autonomic cephalalgia
    • Has any medical contraindication to the use of an oral triptan
    • Previously treated with erenumab
    • Previously treated with a gepant (small molecule calcitonin gene
    related peptide receptor [CGRP-R] antagonist) in a preventive fashion
    • Previously treated with a ligand-based anti-CGRP monoclonal antibody
    (ie, fremanezumab, galcanezumab and/or eptinezumab) in a manner
    consistent with migraine prevention that either:
    (a) in the opinion of the investigator, did not offer any evidence of a
    therapeutic response
    OR
    (b) was discontinued for less than 12 weeks from the date of initial
    screening
    OR
    (c) was previously discontinued due to a known adverse drug reaction
    • Currently being treated with lasmiditan and/or a gepant in the acute
    setting
    • No therapeutic response with > 4 of the defined medication categories
    after an adequate therapeutic trial
    • Currently has a history of consistent excellent response to oral
    triptans, defined as achievement of pain-freedom in ≤ 1 hour for ≥ 50%
    of treated attacks of at least moderate pain intensity during the 3
    months prior to screening
    • Use of triptans administered via a non-oral (eg, subcutaneous [SC] or
    intranasal delivery systems) or sublingual route at the time of screening,
    during the run-in and baseline periods, and throughout the study
    duration
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in mean monthly hours of at least moderate headache pain intensity over months 1, 2, and 3
    E.5.1.1Timepoint(s) of evaluation of this end point
    Months 1, 2, and 3
    E.5.2Secondary end point(s)
    - Change from baseline in mean monthly function domain score as
    measured by the Migraine Functional Impact Questionnaire (MFIQ) over
    months 1, 2, and 3:
    − Impact on physical functioning
    − Impact on usual activities
    − Impact on emotional functioning
    − Impact on social functioning
    - Change from baseline in mean monthly average duration of at least
    moderate pain intensity in qualifying migraine attacks occuring over
    months 1, 2, and 3
    - Change from baseline in mean monthly average peak migraine pain
    intensity as assessed by the 11-point Numeric Rating Scale (NRS) over
    months 1, 2, and 3
    E.5.2.1Timepoint(s) of evaluation of this end point
    Months 1, 2, and 3
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days19
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 386
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 190
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 576
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-26
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